Third annual meeting of New Delhi, India, 23–25 April 2019 South-East Asia Regulatory Network SEARN SOUTH-EAST ASIA REGULATORY NETWORK SEA- -HSD 397 Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK New Delhi, India, 23–25 April 2019 SEA-HSD-397 Third annual meeting of South-East Asia Regulatory Network SEA-HSD-397 © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. 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The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Printed in India Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK iii Contents Acronyms v Executive summary ix 1. Introduction 1 2. Objectives 2 General objective 2 Specific objectives 2 3. Proceedings – Day 0 (23 April 2019): Preparation for 3rd SEARN Annual Meeting by Steering Group and Working Group 3 Welcome remarks – Dr Phylida Travis, Director, Department of Health Systems Development, WHO SEARO 3 Welcome address – Dr Eswara Reddy, Drug Controller General (India) and Chair of 3rd SEARN Annual Meeting 3 Welcome address – Mr Arun Singhal, Additional Secretary, Ministry of Health & Family Welfare, Government of India 4 4. Inaugural session – Day 1 (24 April 2019) proceedings 7 Welcome address – Dr Henk Bekedam, WHO Representative to India 7 Keynote address – Ms Preeti Sudan, Secretary, Ministry of Health & Family Welfare, Government of India 7 Opening remarks – Dr Poonam Khetrapal, Regional Director, WHO South-East Asia Region 8 SEARN: progress and expectations from the meeting – Michael Ward and Dr Manisha Shridhar 10 Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORKiv 5. Working group discussions 13 Working group 1 – quality assurance and standards of medical products including laboratories – Dr Gagandeep Kang 13 Working group 2 (WG 2) – good regulatory practices including GMP, GDP etc. 23 Technical discussions 27 Working group 3: vigilance for medical products 32 6. Day 2 Proceedings – 25 April 2019 35 Address by Dr Phyllida Travis, Director, Health Systems Development, WHO-SEARO: Achieving UHC: targets, trends and the contribution of networks such as SEARN 35 Working group 4: information sharing platform 36 Presentation by working group 5 40 Technical discussion 44 Regulatory support for antimicrobial resistance 48 7. Closing session 54 Annexes 1. Agenda 57 2. List of participants 58 3. Address by the Regional Director at the 3rd Annual meeting of South-East Asia Regulatory Network (SEARN) 67 Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK v ACronyms ADB Asian Development Bank ADR Adverse Drug Reaction AEFI Adverse Events Following Immunization AHWP Asian Harmonization Working Party AMDC ASEAN Medical Device Committee AMR Antimicrobial resistance APEC Asia-Pacific Economic Cooperation API Active Pharmaceutical Ingredient ASEAN Association of Southeast Asian Nations ATC Anatomical Therapeutic Chemical AU African Union AUDA African Union Development Agency AVAREF African Vaccine Regulatory Forum NEPAD New Partnership for Africa’s Development CDSCO Central Drug Standards Control Organization CIP WHO Coalition of Interested Partners CoPP Certificate of a Pharmaceutical Product CoRE Centre of Regulatory Excellence CTD Common Technical Document CWWG Consultative Expert Working Group DEVCO International Cooperation and Development DFAT Department of Foreign Affairs and Trade EML Essential Medicines List EOI Expression of Interest EQAS External Quality Assurance Scheme EQUAAS External Quality Assurance Assessment Scheme EU European Union FDC Fixed Dose Combination GCP Good Clinical Practices GDP Good Distribution Practices GHTF Global Harmonization Task Force GMP Good Manufacturing Practices Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORKvi GMS Greater Mekong Sub-region GPvP Good Pharmacovigilance Practices GRP Good Regulatory Practices GSPA Global Strategy & Plan of Action on Public Health, Innovation & Intellectual Property HQ Headquarters ICMR Indian Council of Medical Research IDMP Identification of Medicinal Products IDP Institutional Development Plan IFPMA International Federation of Pharmaceutical Manufacturers and Associations IMDRF International Medical Device Regulators Forum IPC Indian Pharmacopoeia Commission IQ Installation qualification ISG Interim Steering Group ISP Information Sharing Platform IVD In-vitro diagnostic LMIC Low and middle-income countries MedDRA Medical Dictionary for Regulatory Activities MHRA Medicines and Healthcare products Regulatory Agency MNCL Medicine National Control Laboratory MOU Memorandum of Understanding MQCL Medicine Quality Control Laboratory NCD Noncommunicable Disease NCL National Control Laboratory NGO Nongovernmental organization NIB National Institute of Biologicals NRA National Regulatory Authority PAHO Pan American Health Organization PQ Pre-qualification PSUR Periodic Safety Report Updates PV Pharmacovigilance QC Quality Control QMS Quality Management System RSP Regulatory Strengthening Program Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK vii RWRS Regional Working Reference Standards SDG Sustainable Development Goal SEA South-East Asia SEAR South-East Asia Region SEARN South-East Asia Regulatory Network SG Steering Group SOP Standard Operating Procedure SSFC Substandard, Spurious, Falsified and Counterfeit TGA Therapeutic Goods Administration THSTI Translational Health Science and Technology Institute UMC Uppsala Monitoring Centre WG Working Group WHO World Health Organization DDD Defined Daily Dose WPRO Western Pacific Regional Office XML eXtensible Markup Language Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORKviii VISION “Healthy populations with timely access to affordable medical products of assured quality, safety and efficacy in all countries of the South-East Asia region and beyond.” Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK ix exeCutive summAry Introduction The WHO South-East Asia Region Member States launched South-East Asia Regulatory Network (SEARN) to enhance information-sharing, collaboration and convergence of medical product regulatory practices across the Region to guarantee access to high-quality medical products. SEARN’s guiding vision is healthy populations with timely access to affordable medical products of assured quality, safety and efficacy in all countries of the South- East Asia region and beyond. The 3rd Annual Meeting of SEARN was held at New Delhi, India from 24–25 April 2019. It was preceded by a meeting for preparatory work by the Steering Group and the five Working Groups on 23 April 2019. A total of 68 participants attended the meeting, including representatives from National Regulatory Authorities of SEARN Member States; WHO Headquarters, South-East Asia Regional Office and Country Office for India; and technical experts from Bill & Melinda Gates Foundation (BMGF), Therapeutics Goods Administration (TGA) Australia, Medicines Patent Pool (MPP) Switzerland, and Center of Regulatory Excellence, Singapore. Resource persons included technical experts from specialized organizations such as Translational Health Science and Technology Institute (THSTI), National Institute of Biologicals (NIB, Ministry of Science & Technology, Andhra Pradesh Medtech Zone, United States Pharmacopoeia and Centre for Development of Advanced Computing. The discussions directly leading to the 3rd Annual Meeting are: (1) Regional Meeting for Promoting Cooperation for Regulation in Trade of Medical Products WHO-SEARO, New Delhi, India, 22–24 September 2015. (2) Annual Meeting of the Interim Network for Promoting Cooperation for Regulation of Medical Products in SEA Region in Bangkok, Thailand, 17–18 August 2016. (3) First Annual Meeting of South-East Asia Regulatory Network, New Delhi, India, 11–12 April 2017 (4) Second Annual Meeting of South-East Asia Regulatory Network, Colombo, Sri Lanka, 21–23 March 2018. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORKx Governance A Steering Group (SG), which was set up at the 1st Annual meeting of SEARN in April 2017 guides the network. As agreed upon by the Member States, it comprises of three permanent members – India, Indonesia, Thailand, and two other members nominated by consensus for a one year term on a rotational basis. In addition, SEARN has five Working Groups (WG): WG 1 – Quality assurance and standards of medical products, including labs WG 2 – Good Regulatory Practices (GRP) including GMP, GDP etc. WG 3 – Vigilance for medical products WG 4 – Information Sharing Platform WG 5 – Medical devices and diagnostics WG 5 was set-up at in 2018 at the instance of Member States to provide a greater focus and attention to the emerging area of importance – medical devices and diagnostics. Progress review Following the 2nd Annual Meeting of the SEARN in 2018, members of the SG and WGs met through a series of teleconferences/virtual meetings to review the progress. During the teleconferences, the WGs also approved the agenda and the tentative program for the preparatory meeting on 23 April 2019 prior to 3rd Annual SEARN meeting (24–25 April 2019). In addition, the following actions points were taken up during the teleconference: ¤ Dr Nora Dellepiane, Quality Risk Management (QRB) Consultants Sàrl Quality and Regulation of Biological, formerly with WHO, was engaged to provide a draft strategic plan 2019–2013 for SG and five WGs. ¤ Dr B. B. Rewari, special invitee from WHO-SEARO suggested a pilot project on HIV/AIDs for Fixed Dose Combinations of tenofovir, lamivudine and dolutegravir (new regimen recommended by WHO) for HIV, and sofosbuvir plus daclatasvir combinations for hepatitis. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK xi Objectives of the 2019 meeting General objective Promote collaboration among the Region’s medical products’ regulatory agencies at the 3rd Annual Meeting of the South-East Asia Regulatory Network. Specific objectives ¤ Review progress on agreed deliverables of the Steering Group and the five Working Groups ¤ Promote adoption of the work plan and to agree on next steps by SEARN partners. Deliberations of the meeting The first day, 23 April 2019, was Day 0 where the Steering Group and all the Working Groups reviewed progress made and finalised their work plans. The full SEARN meeting took place on 24–25 April 2019. Dr S. Eswara Reddy, Drugs Controller General (India), Ministry of Health & Family Welfare (MoHFW), Government of India chaired the meeting. Dr Manisha Shridhar and Dr Michael Ward presented the overview. Delivering the keynote address, Ms Preeti Sudan, Secretary, Ministry of Health & Family Welfare, Government of India said that she was pleased that the network has made good progress. She congratulated the regulatory authorities from the WHO South-East Asia Region who had come together and also the WHO South-East Asia Regional Office (SEARO) for the progress made so far (Annex – pl include transcript) . Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia set the tone and tenor of the meeting in her address (Annexure). “The contributions you make will play a pivotal role in ensuring SEARN achieves its objectives and accelerates progress towards UHC – one of the Region’s Flagship Priorities, a core aim of WHO’s 13th General Programme of Work, and the key to reaching Sustainable Development Goal 3,” she said. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORKxii Expert presentations The meeting deliberated on a number of subjects to enhance collaboration and strengthen the regulation systems in the SEARN. In this context, experts made the following presentations: ¤ Regulatory Strengthening Initiatives: Smart Safety Surveillance (3S) – Global Vigilance Strengthening Program Update – Dr Raj Long, Bill & Melinda Gates Foundation ¤ Developing Regulatory Pathways: Clinical Research (CHIMS) & CEPI (challenge models) – Dr Gagandeep Kang, Translational Health Science and Technology Institute ¤ Laboratory strengthening and quality control of biologicals – Dr Surinder Singh, National Institute of Biologicals ¤ Strengthening the Med-tech Ecosystem in India: From Ideation to Market – Dr Alka Sharma, Department of Biotechnology, Ministry of Science & Technology, India ¤ MPP Licenses and opportunities for introduction of new products – Dr Charles Gore, Medicines Patent Pool (MPP), Switzerland ¤ WHO Regulatory Framework for Medical Devices – Dr Gaby Henriette Vercauteren, WHO-HQ ¤ Improved regulatory practice through regional collaborative mechanisms: Enabling improved access to high quality, safe and effective medicines – Dr Paul Hul, Indo-Pacific Regulatory Strengthening Program, Therapeutics Goods Administration, Australia WHO facilitators provided technical support to the meeting. Mr Stephane Guichard and Dr Aparna Singh Shah, SEARO, guided the work on Quality assurance and labs, and Dr Klara Tisocki and Dr Kim Sung Chol, SEARO on Good Regulatory Practices (GRP) including GMP, GDP etc. Dr Tisocki also made a presentation on Regulatory support for Antimicrobial Resistance (AMR) in the Region. Dr Madhur Gupta provided technical inputs on the subject with specific reference to India. She also guided the vigilance of medical products WG. Dr Manisha Shridhar provided details of the Information Sharing Platform (ISP) for SEARN. Ms Gaby Vercauteren, WHO-HQ and Dr Shridhar guided the work on medical devices and diagnostics. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK xiii Outcomes and recommendations The following are the outcomes and recommendations of 3rd SEARN Annual Meeting: ¤ New members of the Steering Group for the current year were nominated – Nepal and Bhutan. The two members join the three permanent members India, Indonesia and Thailand. ¤ Key work plan activities were discussed and identified for each of the five Working Groups. Steering Group recommendations (1) Strengthening of NRAs on quality lifecycle by: ¤ Encouraging reliance ¤ Information sharing and reliance (2) SG to oversee the recommendations made by WGs ensuring: ¤ There are no overlaps ¤ Concrete and realistic deliverables ¤ Clear setting of priorities ¤ Connectivity among working groups Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORKxiv (3) Member States should identify training needs, highlighting their strengths, best practices and support they can extend to other members. (4) WHO may also provide support towards compliance of the identified training needs. (5) Reinforcement of post-marketing surveillance and combating AMR. The SG also identified two new areas, which could be considered as agenda items for next SEARN meeting: ¤ Pharmaceutical abuse through internet sales ¤ Nutraceuticals/dietary supplements repurposing of existing molecules to encourage the use of established molecules where safety and efficacy is proven. Recommendations of the Working Groups Working Group 1: Quality assurance and standards of medical products, including labs Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK xv Short-term (2019) ¤ Use External Quality Assurance Assessment Scheme (EQAAS) enrollment inventory of pharmacopeia for all the priority products. ¤ Develop and circulate KPIs. ¤ Undertake gap analysis in the country requesting for lab support. ¤ Identify gaps – Lack of reference standards, supply issues. ¤ Enhance capacity-building in quality control of diagnostics. Medium-term (2020) ¤ Test ISP gateway; share information on working standards and reference substances. ¤ Implement use of consensus documents for testing of priority medicines, biological and IVDs. ¤ Select one medicine from SEARN priority list to be tested by three labs. ¤ Identify centres of excellence by product categories. ¤ Evaluate inter-lab comparison results and principles of EQAAS in labs in the region. ¤ Establish in country mini-labs and evaluate their performance at Medicine Quality Control Laboratory (MQCL)/National Control Laboratory (NCL). Working Group 2: Good Regulatory Practices including GMP, GDP, etc. ¤ Enhance capacity-building in GRPs: Priority training in 2019 and 2020 and identification of regional training opportunities. ¤ Pilot project on joint assessment of a selected HIV or Hep C fixed dose combination product by SEARN countries- India to facilitate this pilot having the experience previously of parallel review with Men A Vaccine. ¤ Develop Working Group 2 website within ISP for confidential information sharing. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORKxvi Working Group 3: Vigilance for medical products Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK xvii Short-term ¤ Develop a Regional Guidance document to ensure Good Pharmacovigilance Practices (GPVP) in the SEARN. ¤ Launch the GPVP guidance document through the ISP. ¤ Develop a mobile app for SEARN to ensure ease of adverse drug reaction (ADR) reporting. ¤ Organise training programmes for Member States – Workshop on basics of pharmacovigilance and strengthening pharmacovigilance systems in countries; Signal detection and management; and Strengthening blood products vigilance in SEARN. ¤ Develop SEARN database for priority diseases, including from databases like Uppsala Monitoring Centre (UMC) – Adopt a step-wise approach, identify products in priority diseases for end-to-end surveillance. Medium-term ¤ Priority diseases of the region – Integration of public health programs such as TB, HIV, malaria, immunisation programs etc. ¤ Enhance regulatory capacity-building, including PV inspections. ¤ Explore sustainable financial models for funding . Long-term ¤ Undertake training on medicines and vaccines Safety monitoring including learnings from smart safety surveillance approaches among the SEAR countries. ¤ Explore sustainable financial models for funding. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORKxviii Working Group 4: Information Sharing Platform ¤ Provide link to ISP on home page of all NRAs and SEARO website. ¤ Minimum information to be published on ISP – manufacturing facilities, medical product approvals, license details, quality control labs, GMP status, Certificate of a Pharmaceutical Product (COPP). Use common standards (including data standards Leverage existing platforms/international experiences. Working Group 5: Medical devices Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK xix ¤ Utilise ISP for WG 5 for sharing information e.g. on safety alert due to faulty medical device and IVD as substantiated with evidence. ¤ Map the medical devices and IVDs adverse events reporting and recall guidelines and requirements for SEARN countries. ¤ Collaborate with WHO to develop biological reference standards for IVDs. ¤ Map the laboratory capacity in the region for testing of medical devices and IVDs. Conclusion ¤ The 3rd SEARN Annual Meeting brought together representatives from all regulatory agencies in the South-East Asia Region along with the subject matter experts. Members of the SG and WGs reviewed progress of work plans of the last SEARN meeting and deliberated on next steps and action plans to take SEARN forward. ¤ The participants reiterated the need to have a SEARN structure that is light, nimble and innovative. It was suggested that it would be important to explore financial support for SEARN from various institutional mechanisms. Participants felt that it would be important to engage in short-term work plans, keeping firmly in focus, the long-term plans of the respective working groups and the SEARN objectives. WHO secretariat will continue to extend best possible support to SEARN Member States. Further, the members agreed to convene at the next annual meeting at Jakarta, Indonesia in 2020.
Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 1 1. introduCtion The 3rd Annual Meeting of the South-East Asia Regulatory Network (SEARN) was held in New Delhi, India from 23–24 April 2019 to take forward and build on the progress made at the 1st Annual Meeting of SEARN at New Delhi (11–12 April 2017) and the 2nd Annual Meeting at Colombo, Sri Lanka (21–23 March 2018). SEARN was launched by Member States of WHO South-East Asia Region in Bangkok, Thailand in August 2016 following a recommendation of the Regional Meeting for Promoting Cooperation for Regulation in Trade of Medical Products held at New Delhi in September 2015. SEARN objectives ¤ Information sharing: Create an enabling environment to enhance communication and information sharing on regulatory policies, guidelines, standards, procedures, outputs and regulated products and entities between national regulatory authorities in the region. ¤ Systems strengthening: Facilitate and support regulatory capacity development to enhance regulatory skills and competencies and strengthen regulatory systems in the region. ¤ Convergence: Promote convergence and alignment of regulatory approaches and requirements based on international standards and good regulatory practices. ¤ Collaboration: Identify and develop potential work sharing and reliance processes to help address common work areas and optimize use of existing regulatory capacities and expertise available in the region. It was envisaged that SEARN would take forward the aspirations of Member States in line with Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA), World Health Assembly Resolution WHA61.21, Regulatory system strengthening for medical products, WHA67.20 and the South-East Asia Regional Committee resolutions SEA/RC59/R9 on International Trade and Health, SEA/RC62/R6 on Measures to ensure access to safe, efficacious, quality and affordable medical products, and SEA/RC66/R7 on Effective management of medicines. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK2 2. objeCtives General objective The general objective of the 3rd Annual Meeting of SEARN was to promote collaboration among the regulatory agencies for medical products in the South-East Asia Region.s Specific objectives 1. Review progress on agreed deliverables of the Steering Group and the four Working Groups; and 2. Promote collaboration and to agree on Strategic Plan 2019–2023 fo SEARN. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 3 3. ProCeedinGs day 0 (23 April 2019): Preparation for 3rd seArn Annual meeting by steering Group and Working Group The 3rd SEARN Annual Meeting was organized in two parts: 1. Day 0 (23 April 2019) – preparatory work by SG and WGs 2. Day 1–2 (24–25 April 2019) – 3rd SEARN Annual Meeting Dr Manisha Shridhar, focal point SEARN and Regional Advisor for Intellectual Property Rights, Trade and Health, WHO SEARO provided a brief introduction to the meeting. Dr S. Eswara Reddy led the discussions as Chair of SEARN with the support of the participating regulatory agencies to arrive at tangible outcomes. Officials of WHO-HQ, Regional Office and WHO Country Office and Ministry of Health, India supported the 3rd SEARN Annual Meeting 2019. Welcome remarks – Dr Phylida Travis, Director, Department of Health Systems Development, WHO SEARO Dr Phylida Travis welcomed the participants urging that SEARN needs to continue to be useful to thrive. Equally, all should benefit from improved access of essential medical products, which are safe and of good quality. Dr Travis said that the presence of some of the participants for the third time was a testament to the benefits that SEARN was providing. Welcome address – Dr Eswara Reddy, Drug Controller General (India) and Chair of 3rd SEARN Annual Meeting Welcoming the participants, Dr Reddy said that SEARN is a path-breaking initiative for achieving the common objective of enhancing information sharing and Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK4 collaboration leading to convergence of regulatory practices across the region. Dr Reddy urged for greater collaboration and reliance among SEARN Member States. “Greater harmonization—coordination and alignment of regulatory rules across nations would be beneficial for better public health outcomes.” – Dr Eswara Reddy Dr Reddy also suggested that all the Working Groups should interlink with each other, especially the fourth working group, the Information Sharing Platform. Welcome address – Mr Arun Singhal, Additional Secretary, Ministry of Health & Family Welfare, Government of India In his welcome remarks, Mr Singhal highlighted the importance of SEARN in providing member countries an opportunity to learn from one another other. He urged for greater reliance on one another and developing a common regulatory language so that the standards that each country has can be harmonised. Quoting the Indian example of sharing information about every licence granted for medical products through the web portal, ‘SUGAM’, Mr Singhal recommended developing a similar mechanism to share such information among member NRAs Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 5 through a common platform. “It may be a good starting point in building confidence and trust,” he said. Mr Singhal also shared that the India’s Health Ministry is committed to a robust regulatory system for ensuring safety, quality and efficacy of medical products. “Regional collaboration and harmonization efforts will not only help to reduce duplication of efforts and optimise use of limited resources, it would also give patients faster access to new medicines and might lower the costs of drug development, making new drugs more affordable in many more markets.” – Mr Arun Singhal Objectives of Day 0 (23 April 2019) Dr Manisha Shridhar, Regional Adviser, Intellectual Property Rights, Trade and Health, WHO – SEARO shared the genesis of SEARN, the objectives and expected outcomes of Day 0 of the meeting. She expressed her gratitude to Dr Eswara Reddy for his support in hosting the 3rd SEARN Annual Meeting in India. Dr Shridhar stated that all regulatory agencies in the Region felt the need for leveraging one another’s strengths and expertise. She said that regulators are faced with challenges in terms of decision-making with more complex medical products, Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK6 including medicines, medical devices, vaccines and diagnostics. “In a changing environment with the increase of new products and addition of new areas such as personalised therapies, regulators are faced with greater challenges and it has become a mainstream agenda,” she said. Mr Michael Ward, Coordinator, Regulatory Strengthening, WHO HQ Mr Ward expressed his satisfaction at the remarkable progress SEAR has made in such a short period of time since the first informal discussion with Dr Shridhar in Sri Lanka in 2015 when they recognized the need for a regulatory network for this region. He was appreciative of the commitment of the national regulatory authorities (NRAs) in making this possible. Mr Ward highlighted that transparency is one of the key good regulatory practices as it promotes awareness, trust and confidence. Dr Nora Dellepiane, QRB Consultants Sarl, Quality and regulation of Biologicals, Switzerland Dr Dellepiane shared the progress on the development of a strategic plan for SEARN. She said that the ambitions and objectives of the SEARN members should be fully reflected in the strategic plan. The plan will be a useful tool to describe the expected objectives and monitor progress. She felt that a five-year plan provides the right timeframe to achieve both short and long-term objectives. Format of 3rd SEARN Annual Meeting and process for SG and WGs Day 0 was allocated for SG and WG meetings to discuss the substantive work pertaining to each priority area and the process to take this work forward. 3rd SEARN Annual Meeting 2019 was taken up later as Day 1 and Day 2 Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 7 4. inAuGurAL session day 1 (24 April 2019) proceedings Welcome address – Dr Henk Bekedam, WHO Representative to India Extending a warm welcome to the participants, Dr Bekedam congratulated SEARN members for the remarkable progress made in a very short time span. Dr Bekedam stated that the network has a crucial role to play in achieving UHC, which is about services and access to medical products that are of good quality, safe, efficacious and affordable. Dr Bekedam said that the Region has contributed substantially to prequalification; two-thirds of all the finished pharmaceutical products for the prequalification programme and nearly 60% of the active pharmaceutical ingredients (API) come from India. These developments are also important for the global access to quality products. Referring to the importance of generic medicines, he also stressed on the importance of innovation. These are some of the elements he felt that SEARN could facilitate. Keynote address – Ms Preeti Sudan, Secretary, Ministry of Health & Family Welfare, Government of India Welcoming the participants, Ms Sudan said that she was pleased that the network has made good progress. She congratulated the regulatory authorities from the South-East Asia region who had come together and also the WHO South-East Asia Regional Office (SEARO) for extending support for the meeting. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK8 Ms Sudan also outlined the country’s strong resolve to strengthen the drug regulatory system and make the processes transparent, less discretionary and more participatory. In this context, she shared that the ministry has notified Medical Devices Rules, 2017 for comprehensive regulation of medical devices, including their import, clinical investigation, manufacture, sale and distribution. An e-governance portal (SUGAM portal) has also been set up to provide a single window for multiple stakeholders (pharma industry, regulators, citizens) involved in the processes of Central Drugs Standards Control Organisation. Ms Sudan informed that recently, the new Drugs and Clinical Trials Rules, 2019 has been introduced to boost indigenous pharma research in the country and help bring more global trials, both from domestic and multinational corporations. Opening remarks – Dr Poonam Khetrapal, Regional Director, WHO South-East Asia Region Welcoming the participants, Dr Poonam Khetrapal Singh said, “The contributions you make will play a pivotal role in ensuring SEARN achieves its objectives and accelerates progress towards UHC – one of the Region’s Flagship Priorities, a core aim of WHO’s 13th General Programme of Work, and the key to reaching Sustainable Development Goal 3.” Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 9 Dr Singh invited reference to the 2018 Delhi Declaration on Improving Access to Essential Medical Products, which each of the Region’s Member States endorsed: We will “continue momentum to strengthen regulatory cooperation and collaboration to improve the availability, quality and safety of essential medical products through the South-East Asia Regulatory Network.” This she said is an opportunity to to do precisely that, and build on the progress made at the second Annual Meeting in Colombo last year. “WHO is committed to supporting SEARN enhance country cooperation, and in doing so, work towards sharing regulatory resources. These outcomes will be especially useful to the Region’s smaller countries due to the economies of scale they will have access to.” – Dr Poonam Khetrapal Singh The ISP Gateway was launched at the inaugural session of ‘2nd World Conference on Access to Medical Products-Achieving the SDGs 2030’ on 9 October 2018 by the then Health Minister of India Mr. J.P. Nadda and Dr Singh. Referring to WHO’s triple billion targets, Dr Singh said the efforts of Member States and SEARN to increase access to medical products are crucial to achieving them, and to staying on track to realize our own Flagship Priority and reach SDG 3 – to ensure healthy lives and promote health and well-being for all, at all ages. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK10 SEARN: progress and expectations from the meeting – Michael Ward and Dr Manisha Shridhar Mr Ward stated that it is with great pride and a sense of satisfaction that he reflects on the remarkable progress made over the last few years and the coming to fruition of a concept for a regulatory network in WHO South-East Asia. He shared how this structured platform and governance framework that has been put in place with the launch of 5 WGs guided by the SG and supported by an interim Secretariat provided by the WHO SEARO. Convergence, collaboration, reliance are now in the lexicon of the common regulatory language and thinking. Getting to know one another is the first step in building awareness, trust and confidence and crucial for taking concrete steps towards regulating. Mr Ward also reiterated the importance of transparency. Dr Manisha shared the rationale for the establishment of SEARN. She also refered to the WHO Regional Committee (RC) and World Health Assembly (WHA) resolutions, which support the formation of networks to address regulatory issues: ¤ World Health Assembly Resolutions WHA 61.21; WHA 67.20 ¤ South East Asia Regional Committee Resolutions ¢ International Trade and Health: SEA/RC59/R9 to assist Member States in strengthening their National Regulatory Authorities ¢ Progress report on Consultative Expert Working Group on Research and Development (CEWG): Financing and Coordination SEA/RC65/R3 ¢ 2017: Hepatitis: SEA/RC70/7: Support Member States in ensuring access to quality drugs for the treatment of hepatitis C at affordable prices through sharing of information on pricing, and facilitating negotiations through the South-East Asia Regulatory Network –SEARN ¢ 2017: Access to medicines SEA/RC70/9:technical consultations to develop inter-country cooperation through SEARN ¤ Delhi Declaration 2018 – SEARN Dr Shridhar also shared the milestone meetings that have marked SEARN’s progress since 2015: ¤ Regional Meeting for Promoting Cooperation for Regulation in Trade of Medical Products at WHO-SEARO, New Delhi, India on 22–24 September 2015 – it was agreed that there is an immediate need to develop a regulatory Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 11 affairs network for cooperation. Annual Meeting of the Interim Network for Promoting Cooperation for Regulation of Medical Products in SEA Region held at Bangkok, Thailand on 17–18 August 2016 – Interim Steering Group was established 1st Annual meeting of South-East Asia Regulatory Network (SEARN), New Delhi, India on 11–12 April 2017 – Steering Group and Working Groups were established. 2nd Annual meeting of SEARN at Colombo, Sri Lanka on 21–23 March 2018 ¤ 2nd World Conference on Access to Medical Products – Achieving the SDGs 2030 at New Delhi on 9th October 2018 – Launch of the ISP Gateway Suggestions for the WGs Dr Shridhar updated the participants on the progress made by SEARN and the suggestion from SG and WGs: (a) Develop work plan for WGs for the next two years (b) Suggest what should be included in the five-year Strategic Plan (2019–2023) (c) ISP should support all WGs (d) Align WG activities/proposals with the overall objectives set by SG She also shared suggestions specific to each WG: Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK12 Working groups Specific proposals WG 1 – Quality assurance and standards of medical products, including labs Review progress on Expression of Interest (EOI) on the labs to be involved in the Medicine Quality Control Laboratories (MQCL) Network – Indonesia, India and Thailand have expressed interest. WG 2 – Good Regulatory Practices (GRP), including GMP, GDP etc. Pilot the project for accelerated registration for Fixed Dose Combination (FDC) WG 3 – Vigilance for medical products Develop the Regional Guidance Document on Good Pharmacovigilance Practices WG 4 – Information Sharing Platform • Update ISP with information regularly • Undertake security audit of the SEARN • ISP Gateway should support all WGs WG 5 – Medical devices and diagnostics Map medical device regulations for SEARN countries for current situation and next steps Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 13 5. WorKinG GrouP disCussions Working group 1 – quality assurance and standards of medical products including laboratories – Dr Gagandeep Kang A priority activity agreed at the 2nd SEARN Annual Meeting was to establish the Medicine Quality Control Laboratories network. To take this agenda forward, WG 1 applied the risk-based approach to select a basket of priority products for testing and recommended mapping Medicine Quality Control Laboratories, which have the capacity to provide testing support to SEA countries who have limited strength in this area. Expression of interest (EOI) was received from the following labs to be a part of Medicine Quality Control Laboratories (MQCL) Network: 1. Indian Pharmacopoeia Commission (IPC) Ghaziabad, India 2. Regional Drug Testing Laboratory, Guwahati, India 3. Regional Drug Testing Laboratory, Chandigarh, India 4. Central Drug testing Laboratory, Mumbai, India Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK14 5. The Bureau of Drug and Narcotic, MoPH, Nonthaburi Thailand 6. National Agency of Drug and Food Control (NADFC), Indonesia From this list, the following three agencies were shortlisted based on the identified criterion. Indian Pharmacopoeia Commission (IPC), Ghaziabad, India The IPC is WHO prequalified and NABL accredited in the field of Chemical and Biological Testing as per ISO 17025: 2005. It also has a Reference Material Producer Accreditation as per ISO 17034: 2016 and Proficiency Test Provider Accreditation as per ISO 17043: 2010. IPC is an NABL approved testing laboratory; it is one of the mandatory requirements of NABL to participate in the Inter Laboratory Comparison Programme. IPC has been collaborating with countries like Bangladesh and Afghanistan to provide testing support The Bureau of Drug and Narcotic, Ministry of Public Health, Nonthaburi, Thailand achieved WHO PQ in 2012. Since November 2012, it has been on the WHO List of Prequalified Quality Control Laboratories. The lab has received ISO/IEC 17025, ISO 9001: 2015, ISO/IEC 17043 accreditation and participated in proficiency testing organized by EDQM and other bodies since 2014. In addition, it has conducted training programs on Medicines Quality Control for officials from Myanmar and Bhutan national testing laboratories. National Agency of Drug and Food Control (NADFC), Jakarta, Indonesia is WHO PQ certified; the assessment was held in February 2019. It has received ISO 17025 accreditation since 1998 and ISO 9001:2015 accreditation since 2012. The laboratory has participated in proficiency testing organised by EDQM (European Directorate for the Quality of Medicines & HealthCare) and other bodies since 2018. It was highlighted that in India, the National Institute of Biologicals (NIB) is already providing testing and training for biological products (e.g. in vitro diagnostics, vaccines, haemovigilance) to SEAR and other countries. NIB is a WHO Collaborating Centre and can be used by all SEAR countries for quality control of IVDs. WG 1 also deliberated on issues relating to support for testing from MQCLs/ NCLs and capacity-building for MQCL/NCL. The WG agreed on the roadmap for the next five years to overcome the challenges by leveraging the existing facility and optimal use of resources available in member countries. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 15 The roadmap of proposed activities for 2019–2023 is summarised below: Activity 2019 2020 2021 2022–2024 Specific objective/ responsibility Information sharing/ gateway (WHO to coordinate) Prepare concept/ flyer Achieve consensus on what to publish e.g. actual results, failures, passes, etc Test ISP gateway Share information on working standards and reference substances Share protocols and data on cross-testing and referral testing Implement and review data from first collaborative project and implement next project Share data between NRAs on data beyond referral testing(e.g. pharma- covigilance) Review of platform utility and adaptation Document convergence (3 MQCL/NCL countries) Develop draft formats for requests and circulate Collaborative mechanism established Implement use of consensus documents for testing of priority medicines, biological and IVDs (Define collaborative projects and timelines) Process development (Non-WHO PQ MQCL/NCL countries) Examine legal and logistic requirements, develop pathway Develop performance indicators for each area of work Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK16 Activity 2019 2020 2021 2022–2024 Inter-laboratory comparison for medicines, biologicals and standards (WHO to coordinate) EQAAS enrollment Inventory of pharmacopeia used in SEA countries for all the priority products Develop and circulate KPIs Selection of one medicine from SEARN priority list to be tested by three labs Identify centres of excellence by product categories Evaluate inter-lab comparison results Expand to three more products and classes Review progress and adaptation Support for testing (NIB to conduct survey every two years) Gap analysis in country requesting lab support Define needs for medicines, IVD and biologicals testing Work-plan finalized and implemented Establish in country mini-labs and evaluate their performance at MQCL/NCL Post-implemen- tation evaluation Capacity- building Identify gaps -Lack of reference standards -Supply issues Develop work- plan to address reference standards and use next meeting to share draft approach to sharing Review progress and reassess need At the end of the discussion, the Chair of SEARN 2019, Dr Reddy summarised the major recommendations of WG 1 1. Proper guidelines need to be developed, considering the following points: ¤ Type of tests a particular laboratory can carry out ¤ Their facilities and capacities ¤ Capacity they can spare ¤ Type of equipment and instruments available ¤ Number of samples they can receive from other countries ¤ Fee for testing of a particular drug Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 17 2. Memorandum of understanding (MOU) should be signed between the particular laboratory and the country clearly spelling out who would be responsible for sending the samples and how they would be sent. This could be decided according to rules and regulations prevailing in respective countries. 3. For testing of medicines, the standards claimed by the manufacturer should be used as those are the standards approved by the relevant NRA at the time of granting registration. 4. There should be a mechanism for reliance among member countries on the test reports to avoid duplicate testing. It would, therefore, be best to utilise the WHO prequalified laboratory services for testing. Information about WHO prequalified laboratories should be made available on the ISP. 5. Every laboratory should have a focal point so that they could be directly contacted whenever there is an issue with regards to testing. The MOU should indicate the details of the focal point. 6. While recognising laboratories from India, Thailand and Indonesia as MCQLs, there should be a system to strengthen other NCLs in member countries with the support of WHO, based on a gap analysis conducted by WG 1. Technical presentations Dr Eswara Reddy chaired the technical session with Mrs Korrapat Trisarnsri Director, Thailand as Co-chair. Ms Aishath Mohamed, Deputy Director General Pharmaceuticals, Maldives was the rapporteur of the session. Regulatory Strengthening Initiatives: Smart Safety Surveillance (3S) – Global Vigilance Strengthening Program – Dr Raj Long Dr Raj Long, Deputy Director, Integrated Development – Global Health of Bill & Melinda Gates Foundation (BMGF) shared her experience on the Smart Safety Surveillance (Triple-S) project. BMGF initiated discussions with the Medicines and Healthcare Products Regulatory Agency (MHRA) and WHO Hq to work on safety monitoring. She stated that it was clear that a safety system of the United States or Europe cannot be taken and superimposed in another country due to differences in multiple factors, although the need for safety remains the same. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK18 Dr Long pointed out that safety is about the patient and there are three key partners at country level – the regulator, public health organizations such as WHO and public health teams in disease areas such as malaria, HIV and TB, and also the industry because they are responsible for making the products. Dr Long also described the work initiated by the BMGF Safety Surveillance Working Group (SSWG) to develop a strategy for post-marketing surveillance. The need for post-market safety surveillance was found more pressing for products that would be introduced soon in LMICs. It was also found that there was a huge need for safety monitoring particularly for new products. Dr Long, pointed out that safety starts with preclinical studies with toxicology data in animals followed by Phase I, Phase II and Phase III into the human population. Safety is a continuum and it is not possible to look at the registration to know what has happened in the past. Essentially, there are three components of pharmacovigilance: (a) generation of the data, (b) using that data by reporting, and (c) analysing the data to make an informed decision based on analytics. Taking into account these factors, the working group came up with a value proposition – Triple-S, which is Smart, Safety and Surveillance. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 19 Developing regulatory pathways: Clinical Research (CHIMS) & CEPI (challenge models) – Dr Gagandeep Kang, Translational Health Science and Technology Institute Dr Gagandeep Kang made an exhaustive presentation on the new regulatory pathways in clinical research. She shared the background, human infection model and collation for epidemic preparedness innovations. She also spoke about the challenges in clinical research like pathways to innovation, applicability of clinical trial result in a global arena and the divide between clinical research and clinical practice. Dr Kang illustrated the pathways to innovation with the example of diabetes. In the United States, government-funded clinical trials for diabetes could not be conducted by industry or other sectors as new therapies for type 1 diabetes are of limited interest to pharma because of the small patient population. However, Type 2 diabetes treatment options are avidly pursued. Controlled Human Infection Models (CHIMs) Dr Kang quoted the example of an Indian vaccine. It was licensed in India on the basis of extended immunogenicity studies and then taken to Oxford and tested in a human infection model of Salmonella typhi. It showed that there was about 80% protection induced by the vaccine. This data was reviewed by WHO and the typhoid conjugate Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK20 vaccine made in India has now been prequalified based on the data provided from the human challenge model and the decision of the Indian NRA. The reason for doing the challenge model was that there was really no clinical efficacy data on this model. Controlled human infection models or volunteer infection studies have become core methodology in modern infectious disease research. They have fundamental scientific value because natural infection is very different from a controlled infection where the infectious dose is known when somebody is exposed. Therefore, when measured, the outcomes are more predictable. Coalition for Epidemic Preparedness Innovations (CEPI) Dr Kang informed that CEPI has been established for multiple partners, including the Indian Department of Biotechnology with the idea that it is impossible to beat the epidemics without new vaccines. New vaccines will need new platforms and technologies. There are many possible regulatory strategies that could be used for developing these new products. She focused on the ‘Animal Rule’, which the FDA considers akin to a last-case scenario. This is intended to facilitate licensure of medical counter-measures for lethal or permanently disabling conditions for which, traditional efficacy testing and clinical trials are considered either unethical or logistically impractical. A vaccine, which is under consideration in the Animal Rule is the Ebola vaccine. This is for the second generation vaccine, which is made by Janssen. Under the Animal Rule, some of the requirements are: ¤ The animal studies should have a reasonable likelihood of clinical benefit in humans; ¤ Should understand the toxicity; ¤ The effect should be shown in more than one species, unless there is one animal model, which is very well characterized; ¤ the animal endpoints need to be related to the desired benefit in humans; and ¤ The data should allow for selection of an effective human dose. Dr Kang highlighted the following issues that might come in the future for consideration by the regulators: ¤ New products for existing and emergency conditions will require regulatory innovation; Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 21 ¤ NRAs have grown to such an extent where it is possible now to begin to think about what innovation in the regulatory landscape will look like; and ¤ Innovative new products for the future will involve multiple stakeholders so the earlier these discussions start, the better it is. Laboratory strengthening and quality control of biologicals – Dr Surinder Singh, National Institute of Biologicals In his introductory remarks, Dr Surinder Singh highlighted that a laboratory is an integral component in assuring that drugs and medical products, which reach the end- user are safe, potent and efficacious. National Quality Control Laboratories (NQCLs) are the ones that are most critical in ensuring that these products, whether produced indigenously or imported into the country, safeguard public health. A well-functioning NQCL plays a very important role to combat the challenge of substandard, spurious, falsified and falsely labelled drugs. This protects the consumer from the adverse effects of these types of drugs. Dr Singh described the key challenges of having a good quality laboratory system. Infrastructure It is not just creating the infrastructure but also ensuring its maintenance to reach the laid down benchmarks for the laboratories. The key components are: (i) A well- designed, environmental friendly, safe laboratory for housing of animals and testing of medical products; (ii) Procurement of appropriate equipment, instruments and maintenance, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and calibration; and (iii) Laboratory information management system. Harmonization, coordination among inter-laboratory facilities Through SEARN, member countries can harmonise the activities of the national control laboratories and have a better understanding of the systems, which are being followed. This can be done, within the country as also with the laboratories in the Region. The main components of harmonisation include, firstly, an external Quality Assurance System, which includes proficiency testing, rechecking, re-testing and onsite evaluation of the laboratories; and secondly, a system for objectively checking the laboratory performance by using an external agency or a facility on a regular basis. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK22 Accreditation Accreditation is a critical factor when looking for a lab where samples can be sent for testing. Many countries in the Region have ISO 17025 certified labs; this forms the benchmark to meet the minimum standards, which are required to assure the quality of drugs. Reference standards Reference standards are vital. They could also be the national reference standards e.g. Indonesia could have its own reference standards as could Thailand and India. Getting international reference standards is very costly and all laboratories may not be able to afford it. This can be substituted by having national reference standards, which can be chemical or biological reference standards. However, these must be sourced from authentic sources. It is important that all reference standards are validated and standardised against international reference standards wherever available. Laboratory quality management system A laboratory management system is a key feature in establishing a good quality laboratory in a country. It has three main pillars – organization, personnel and equipment. Each component has to be addressed if overall quality management is to be achieved. It is especially important when aiming at networking and handholding for the laboratories at the country-level in the Region. Networking and work sharing Networking of laboratories helps in expanding the capacity of individual NCLs and NRAs. It also helps in harmonising common standards, best practices and enables experience sharing. Importantly, it builds confidence in evaluations performed by other network members and avoid the same lot being tested unnecessarily and repeatedly by different NCLs. This helps conserve resources, which can be better utilised for other activities. It also reduces the number of animals used for testing. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 23 Working group 2 (WG 2) – good regulatory practices including GMP, GDP etc. WG 2 discussed the following: 1. Proposed work plan for the next two years 2. Pilot project for accelerated registration for FDC 3. Proposed support by ISP to WG 2 4. WG 2 proposal for the Five-Years Strategic Plan (2019–2023) Proposed work plan for the next two years During the WG discussions, the following recommendation were made with regard to GRP: ¤ Capacity-building in GRPs with priority trainings in 2019 and 2020. ¤ Mechanisms by SEARN for accelerated registration of priority medicines. ¢ For this it is necessary to have a strong commitment from the heads of NRAs in countries ¢ Developing a draft roadmap for joint assessment programme for fixed dose combination product for HIV/Hepatitis C medicines Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK24 ¤ A pilot project on joint assessment of selected HIV or Hep C combination product by SEARN countries. ¤ Developing Working Group 2 dedicated website within ISP for confidential information sharing. High priority training programs requested in 2019 (based on response to the survey from eight NRAs) ¤ Good practices for desk assessment compliance with GMP, GLP, GCP for medical products regulatory decisions (Regulation). ¤ Good Regulatory Practices – Principles and implementation of GRPs (Regulation). ¤ Good Review Practices (Product evaluation and other topics). High priority training programs in 2020 (based on response to the survey from eight NRAs) ¤ Good practices for regulation of biological products (Regulation). ¤ WHO good practices for pharmaceutical quality control laboratories (other topics). ¤ Good inspection practices to ensure compliance of distributors, pharmacies with Good Storage Practices (Inspection). ¤ Good practices for desk assessment compliance with GMP, GLP, GCP for medical products regulatory decisions (Regulation). ¤ Good practices for regulation of medical devices (Regulation). Thailand and Indonesia requested for training on IVD and device regulation. Detailed capacity gap assessment and recommendations for training modalities ¤ Detailed online survey to be conducted in 2019: ¢ Identify common capacity improvement, needs-based broader areas of GRPs linked to NRA’s Institutional Development Plan arising from NRA assessment using the Global Benchmarking Tool (GBT): ¢ The main objectives would be to identify: (i) Common, high priority capacity gaps and training needs; (ii) Centres of Excellence with existing training programs; (iii) Granularity of training needs (basic vs advanced training); and (iv) Alternative training modalities, in addition Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 25 to regional/international training workshops (e.g. online courses, exchange programs/study tours (‘peer trainers’ from SEARN NRAs), regular webinars to share best practices, discuss hot topics and emerging problems. Mechanism by SEARN for accelerated registration of priority medicines ¤ Develop draft roadmap for SEARN joint assessment mechanism, with key milestones timeframes, final targets and resource needs identified. Pilot project for accelerated registration for FDC ¤ Joint assessment for priority medicines Organise joint review assessment workshop for select HIV or Hep C products once a company has simultaneously submitted applications in multiple countries (minimum three countries). This has an additional benefit of enhancing country capacity on assessment review. While observers would not have full access to dossier, they can observe the assessment process. Feedback on the process will be taken up at 4th or 5th SEARN meeting, Proposed support by ISP to WG 2 ¤ ISP can provide links to specific areas of SEARN NMRA websites for information already in the public domain. ¤ ISP should have an area specifically for SEARN containing the following: ¢ WG 2 SharePoint for discussion on: – Comparative analysis of SEARN regulatory requirements – Other outputs, as needed ¢ Shared calendar for all trainings/regulatory events within SEARN, as also ASEAN, APEC, Global WHO Trainings, etc. to create regional regulatory training calendar. WG 2 proposal for Five-Years Strategic Plan (2019–2023) ¤ Annual monitoring of capacity-building needs in GRPs ¤ Annual training calendar ¤ Monitoring of training outputs based on progress on IDPs/GBT ratings Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK26 ¤ Collaborative mechanisms by SEARN for accelerated registration of priority medicines: ¢ Development of draft roadmap for joint assessment program ¤ Registration completed for one FDC based on SEARN joint assessment pilot project ¤ Development and maintenance of WG 2 SharePoint within ISP for confidential information sharing Cross-cutting issues ¤ All working groups should consider linkage with GBT IDPs to measure progress ¤ Shared calendar for all trainings/regulatory events within SEARN, as also ASEAN, APEC, Global WHO Trainings, etc. to create regional regulatory training calendar ¤ Marketing authorisation requirement convergence should be linked to pharmacovigilance working group for product lifecycle management ¤ Capacity-building modalities should be assessed by all working groups to identify those that are most impactful/helpful to NRAs ¤ Strategic resource mobilisation to support integrated implementation of working group plans Dr Eswara Reddy summarized the outcomes of WG 2 discussion: ¤ Training is one of the important components. Training needs have to be identified by the respective member country themselves as they are best positioned to identify their own specific needs. He suggested WG 2 to have a recommendation requesting each country to identify their training needs within the next couple of months and share it through the ISP. This would make it possible to identify common needs and organise training programmes accordingly through WHO or other resources. ¤ The platform proposed to be created for accelerated review of FDCs and other medicines could be used for the joint reviews as well. Sharing of dossiers for evaluation by two countries selected as per the similar objectives and requirements is a possibility for joint review. ¤ The centres of excellence in Thailand, India and other countries would be helpful to member states for training. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 27 Technical discussions Parallel review of Fixed Dose Combinations in SEARN – Ms Swati Srivastava, Deputy Drugs Controller (India), Central Drugs Standard Control Organization, India Ms Srivastava started her presentation by sharing India’s experience on Fixed Dose Combinations (FDCs). Describing the joint collaborative procedures based on WHO PQ and joint reviews, Ms Swati informed that it has four steps: Organise joint review assessment workshop for selected HIV or Hepatitis C products, once a company has simultaneously submitted applications in multiple countries (minimum three countries). ¤ Additional benefit: Country capacity on assessment/review enhanced. ¤ Observers would not have full access to dossier but can observe the assessment process. Ms Srivastava stated that the main challenge is that the review procedures in the SEARN countries may be different. It would, therefore, be important to see how different countries come together to follow collaborative review of an application for a FDC. . It would also make it possible to adopt other internationally accepted standards like the International Conference on Harmonisation (ICH). Ms Srivastava presented a list of FDCs chosen by the WG. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK28 Ms Srivastava also shared the experience on parallel review of meningococcal A conjugate vaccine with Biologics and Genetic Therapies Directorate (BGTD) Health Canada, a process through which India licensed a product, a first time in the world. Ms Srivastava outlined the benefits of such a review: ¤ Exchange of scientific knowledge ¤ Identifying the gaps in review process ¤ Learning of product and process review during the on-site evaluation ¤ Interaction and dialogue through teleconferences to gain level of confidence ¤ Timelines for activities ¤ Awareness about the review process approach of the lead NRA ¤ Identification of the areas for further training ¤ Strengthening the regulatory capacity of the NRA Ms Srivastava shared how India benefitted from the parallel review of meningococcal A conjugate vaccine, which was prequalified by the WHO in June 2010. The results: between September 2010 to May 2011, India exported 2 114 668 vials (10 doses each). Strengthening the Med-tech Ecosystem in India: From Ideation to Market – Dr Alka Sharma, Adviser, Department of Biotechnology, Ministry of Science & Technology, India Dr Sharma provided an overview on the efforts of the Indian government to strengthen the med-tech ecosystem in India. She shared that the Department of Biotechnology has been instrumental in developing and implementing the National Biotechnology Development Strategy 2015–2020. The strategy’s key focus is on building a skilled workforce and leadership, building knowledge environment, enhancing research opportunities, and nurturing innovation and entrepreneurship. Realising the need for indigenous innovation of medical technology, the Department of Biotechnology has also implemented the Bio-Design program. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 29 This is an example of inclusive Med-Tech innovation where policies and processes have been streamlined, revenue sharing model finalised and collaborations with the industry established. As a result, more than 50 prototypes have been developed, 16 technologies transferred, 7 medical products commercialised and 10 start-ups created. Dr Sharma also shared examples of technologies licensed and commercialised by other programs in Bio-Design, such as at Indian Institute of Technology (IIT), Chennai and centre for in-vitro diagnostics at THSTI, Faridabad. In addition, biotech parks and incubators have been established to provide ready-to-use infrastructure and business support services to nurture biotech enterprises and minimize their financial burden. The Department of Biotechnology has also launched the National Biopharma Mission; it is a collaboration between the Government of India and World Bank and being implemented by BIRAC. This is an industry-academia collaborative mission for accelerating discovery research for early development of biopharmaceuticals. Vaccines, biosimilars, medical devices and diagnostics are the focus of the mission. The mission connects industry and academia for efficient exchange of knowledge. It also provides enabling support services and required mentorship for intellectual property and technology management, legal and contract resource mobilization networking platforms. In addition, it provides access to world class infrastructure and high-end equipment facilities. BIRAC has so far supported 30 bio-incubators for budding entrepreneurs. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK30 The Government through the Department of Biotechnology is also investing substantially on collaborative programmes like Stanford India Biodesign programme (SIB) and School of International Biodesign to boost medical technology innovation in the country. Dr Sharma highlighted that to ensure sustainability of the created ecosystems, concerted efforts are needed, which include: ¤ Enhancing the connectivity between key players; ¤ Bringing innovators, clinicians and industry to work together on innovative ideas; ¤ Building partnership between academia and industry; ¤ Training the personnel for a understanding of innovation landscape; ¤ Mapping available expertise and common existing resources across the country; and ¤ Streamlining the regulatory processes Dr Charles Gore, Executive Director, Medicines Patent Pool, Switzerland: MPP licenses and opportunities for introduction of new products Describing the vision of Medicines Patent Pool (MPP), Dr Charles said that they visualise a world in which, people who are in need of effective and affordable medical treatments and health technologies have rapid access, especially in the lower-and middle-income countries (LMICs). Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 31 To realise this vision, they negotiate with originator companies for access oriented licences or public health licences to permit generic manufacturers to produce quality but affordable medicines in many LMICs. This is done through an innovative approach to voluntary licensing and patent pooling. It is implemented by working with a range of stakeholders, industry, patient groups and governments. MPP, with a geographic scope of around 100–120 countries, has ensured the delivery of 17 million patient years of treatments and around 6.2 billion doses of medicines through generic partners. This has resulted in savings of around USD 553 million through licenses funded by UNITAID, which facilitates competition to reduce prices and enables innovation in the form of new FDCs and paediatric medicines. Initially working only in HIV, their portfolio expanded to HCV and TB in November 2015. Dr Charles stated that there is a strict quality assurance mechanism in place and their generic manufacturers are required to register with MHRA, FDA or WHO PQ system. He pointed out how all stakeholders benefit from this scheme: ¤ Patent holders – Effective way to make available innovative products in resource poor settings; licence management to ease transaction costs. ¤ Low-cost producers – Simplified approach to the development of affordable versions of existing medicines, creation of needed new formulations. ¤ People living with disease – Gain faster access to quality, appropriate, affordable and life-saving treatments. ¤ Treatment providers and donors – An ability to stretch budgets to treat more people with WHO-recommended medicines. Dr Charles stated that MPP assesses medicines to ensure there is a significant public health benefit in these products. While being concerned about the quality, it recognizes that it cannot expect PQ to cover all products. Therefore, they look at other means also for assuring the quality of products, including serialisation and developing a database and a mobile phone application so that it could be used by anyone to find out if a product is genuine or not. Dr Charles pointed out that if the goal is to provide affordable, quality assured medicines to the people who need them as quickly as possible, SEARN offers a unique opportunity to: Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK32 ¤ Reduce the cost for generic companies of registering medicines, thereby encouraging registration even in small markets; and ¤ Reduce the administrative burden for generic companies of registering medicines, thereby speeding up the availability of new medicines through standardisation, convergence, information sharing, reliance and reduction of extra requirements (e.g. local trials), especially for public health priorities. Working group 3: vigilance for medical products WG 3 discussed the following topics: ¤ Short-term work plan and activities – 2019–21 ¤ Long-term activities over a five-year time frame ¤ SEARN Vigilance e-newsletter Dr V. Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission, MOHFW presented an overview of an end-to-end safety surveillance system for SEARN. In India, pharmacovigilance became a mandatory requirement under the Drugs & Cosmetics Act. Pharmacovigilance Programme of India (PvPI) was launched as a WHO Collaborating Centre for pharmacovigilance in public health programmes and Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 33 regulatory services on 30 October 2017. This is the first WHO Collaborating Centre on this theme in the South-East Asia Region and globally. Dr Kalaiselvan shared that the WG has developed a strategic plan encompassing governance and policy, technology standards, and resources and sustainability. WG 3: Vigilance for medical products Strategic work plan Governance and policy Technology and standards Resources and sustainability 1. Guidance document for GPvP for the Region: – Priority diseases of the Region, including emergencies – Integration with public health programmes such as TB, HIV, malaria, immunization programs etc. 2. PV legislation – Initiation based on gap analysis (where necessary) 3. Communication strategy – common platform to share information 1. ISP Gateway 2. IT tools, mobile apps or paper- based forms for ADr reporting 3. SEARN database – through ISP – with external links like UMC 4. IT tools for data mining and signal detection 1. Training in medicines and vaccines 2. Funding 3. Human resources, including hiring of experts 4. Sustainable financial models such as fees for safety updates and pre-submission safety discussions 5. Regular budget provisionss – from the governmentTraining • Basic concepts and Pharmacovigilance principles, ADr forms, Mobile apps usage • Signal detection, management • Risk benefit assessment • Assessment outcome, Informed regulatory decision making and its communication • Strengthening blood products vigilance in SEARN Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK34 The plan has been broken down into short-term, medium-term and long-term plan and activity. Short-term plan (0–2 years) ¤ Develop a guidance document to ensure Good Pharmacovigilance Practices (GPVP) ¤ Launch the GPVP guidance document through the ISP ¤ Develop a mobile app for SEARN to ensure ease of ADRs reporting ¤ Organise training programmes for Member States ¤ Workshop on basics of pharmacovigi lance and strengthening pharmacovigilance systems in countries ¤ Signal detection and management ¤ Strengthening blood products vigilance in SEARN ¤ Initiate SEARN database for priority diseases, including from databases like UMC ¤ Adopt a step-wise approach and identify products in priority diseases for end-to-end surveillance Medium-term (3–5 years) ¤ PV legislation initiation, where necessary ¤ Priority diseases of the region – integration of public health programs such as TB, HIV, malaria, immunization programs etc. ¤ SEARN database –for signal detection ¤ Regulatory capacity-building, including PV inspections ¤ Sustainable financial models Long-term plan (up to 5 years and plus) ¤ Training on medicines and vaccines surveillance ¤ Funding- Sustainable Financial models ¤ Human resources Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 35 6. dAy 2 ProCeedinGs – 25 APriL 2019 Address by Dr Phyllida Travis, Director, Health Systems Development, WHO-SEARO: Achieving UHC: targets, trends and the contribution of networks such as SEARN Dr Phylida Travis presented a brief overview of how the regulation of medical products is situated within the broader environment of UHC. UHC means everybody gets the health services they need without suffering financial hardships. Dr Travis highlighted the role of networks, including SEARN. She said that by definition, networks are for collaboration and they come in many shapes and sizes with very different memberships and there is no single model. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK36 Working group 4: information sharing platform Mr R. Chandrashekhar, Deputy Drugs Controller, CDSCO, India made a presentation on behalf of WG 4. He pointed out that communication is vital for the success of any organisation. Information and its dissemination is important for organisational cohesiveness and reaching the objectives. WG 4, he said, is the vital thread that binds all WGs together. He described the key features of the ISP (www.searn-isp.org), which was developed with the support of Centre for Development of Advanced Computing (C-DAC). It has two separate views – public and private. The public view, in open domain, provides access to the basic information about the SEARN platform such as objectives etc. The private view contains confidential information that can be accessed only by regulators of the SEARN member countries. This includes details of SG and all WGs, SEARN focal points, regulatory information related to product approvals, WHO COPP, quality-related information, laboratories, NRA details, regulatory framework, calendar (NRAs can post their events, meetings etc. in this section) and gallery of pictures. In addition, role-based software and roles available are for super admin (the person who manages the platform), NRA head and NRA representative. There is also a comprehensive dashboard for each role. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 37 Facilities available for NRAs include member management, discussion forums, meeting management and document and data upload. Mr Chandrashekhar also shared the terms and references for the development of ISP: ¤ Software to be developed by C-DAC within six months from the date of signing the MOU; ¤ Maintenance of software for five years from the date of launch; ¤ Hosting of ISP will be provided by CDSCO on their server; therefore, no additional cost for the server; and ¤ Security audit of ISP by an accredited third party. Suggestions to be incorporated in the ISP ¤ Facility to update focal points details from NRA dashboard ¤ To rename ‘Quality related regulatory actions’ to ‘Quality/ Safety’s ¤ Facility to add events in calendar section by NRA ¤ To rename ‘Drug product approvals’ to ‘Medical product approvals’ ¤ Create a miscellaneous section on the homepage ¤ Prepare user-manual and circulate to NRAs Recommendations of WG 4 ¤ Launch of private ISP services by mid-May 2019 ¤ Link to ISP on home page of respective NRA and SEARO website ¤ Minimum information to be published on ISP to include the following: ¢ Manufacturing facilities ¢ Medical product approvals ¢ License details ¢ Quality control labs ¢ GMP status ¢ COPP Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK38 ¤ Use of common standards such as MedDRA, CTD, WHO DD, ATC Codes, etc. and XML templates ¤ Leverage existing platforms/international experiences ¤ Invite few SEARN countries to Geneva for WHO Identification of Medicinal Products meeting Future enhancements recommended by WG 4 ¤ Facility for working groups to work on live document ¤ IT Helpdesk to be setup of handholding member countries ¤ Enable ISP for tracking and tracing of medical products among SEARN countries ¤ Provision for joint review of applications by member countries for grant of marketing authorization Recommendations by WGs WGs Recommendations WG 1 • Listing of focal point (primary & secondary) for labs with contact details • Sharing of capability and capacity of labs • Details of services offered by labs • SOPs of labs and pharmacopeia standards application • Information related to accreditation • Sharing of alerts and notifications • Legal/government approval processes for using the lab facilities • Costing involved for testing • Sample quality packaging and transportation (ex. thermo-liable samples) • Sharing of test reports Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 39 WGs Recommendations WG 2 • Sharing of various GMP/GLP/GCP/GRP… best practices • Sharing of training requirements and compilation • SharePoint type of collaborative documentation • Provision for joint assessment for accelerated registration FDCs • Exchange of scientific knowledge • Interactive communication • Calendar should include global relevant events like from ASEAN, APEC ASEAN, WHO events. • Provision of online courses and training material (e-learning platform) WG 3 • ISP should be populated and data on vigilance uploaded • Training program for sustainability • Sharing of technology standards • Sharing of vigilance outcome • Mobile App for ADr reporting for SEARN region • Collaborative database for SEARN region for ADR • IT tools for data mining and signal detection • Publishing of e-newsletter WG 5 • Information on safety alerts due to faulty medical devices and IVDs shared on ISP • Creating the medical device and IVDs module (template) on the ISP Timelines proposed Activity/ milestones 2019 2020 2021 2022 2023 Manufacturing site details Details of site and licenses Product approval information Information with NRA’s website to be linked with ISP Gateway, wherever available Information should be made available in English language Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK40 Activity/ milestones 2019 2020 2021 2022 2023 COPP status of the site Details to be made available Alerts /recalls/ seizures /stock manufacturing Details to be made available Laboratories List of medical products testing laboratories to be made available Regulatory framework Link to be made available Uploading of updated important regulatory guideline documents in English National/ regional authorities’ details • Detail addresses and contact numbers • Focal point details for direct communication • Function of NRA authorities • Sharing of training/ conferences/ regulatory events particularly international conferences • Approval and testing procedure • Regulation of other products like veterinary, radio pharmaceuticals etc. • Penalty/ cancellation/ suspension of license Presentation by working group 5 Medical devices and diagnostics Making the presentation on behalf of WG 5, Mr Lupi Trilaksono highlighted that medical device and IVD technology is innovative and growing fast. The surge has led to an increased urgency to set-up a robust regulatory framework. As a result, during the 2nd Annual meeting of SEARN, member countries decided that many activities relating to the priority areas of the following three WGs require focused attention: Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 41 ¤ Quality assurance and standards of medical products, including labs ¤ Good Regulatory Practices including GMP, GDP, etc. ¤ Vigilance for medical products; the focus is only on pharmaceuticals or vaccines Therefore, SEARN constituted an additional Working Group on Medical devices and diagnostics. Objectives and specific objectives of WG 5 Objective Specific objective 1 Information sharing Information sharing gateway 2 Systems strengthening Capacity development 3 Convergence Adoption of common forms and format 4 Collaboration Collaborative registration procedure (voluntary, reliance tools) Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK42 Objective 1 – Information sharing Activity 1 – Information to be shared on ISP for WG5 Output Information on safety alerts due to faulty medical devices and IVDs as substantiated with evidence. Timeline 2019 – Discussions initiated 2020 – Process initiated Milestone Common practice for adverse event reporting of medical devices safety program in SEARN has been adopted Performance indicator Percentage of medical device and IVDs related safety alerts are shared and available Activity 2 – Indonesia & Thailand to share the ASEAN guidelines and forms for adverse event reporting and recall with SEARN Output Harmonised guidelines and reporting format Timeline 2019 – August 2019 confirmation during 8th AMDC meeting 2020 – Updated at the 4th SEARN meeting Milestone Decision to adopt the forms and guidelines Performance indicator Activity 3 – Collaboration with WG 4 (ISP) Output Creating the medical device and IVDs module (template) in the ISP Timeline 2020 Milestone Module is up and running Performance indicator Validation of the module and information uploaded Activity 3 – Information is uploaded and shared Output Information is available for use Milestone Common practice for adverse event reporting of medical devices safety program in SEARN has been implemented Performance indicator Percentage of medical device and IVDs related safety alerts are shared and available Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 43 Objective 2 – Systems strengthening Activity 1 – Map the medical device and IVDs adverse event reporting and recall guidelines and requirements for SEARN countries. Output To incorporate additional information in the existing survey questionnaire Timeline 2019 – Discussion initiated 2020 – Next SEARN meeting Milestone Additional questions to be identified and e circulated to SEARN members Performance indicator Survey completed Activity 2 – Map the laboratory capacity in the region for testing of medical devices and IVDs Output List of laboratories and their scope engaged for testing of medical devices and IVDs Timeline 2019 – Discussion initiated 2020–2023 – SEARN meeting Milestone Information to be shared and updated Performance indicator Information updated is collated Objective 3 – Convergence Activity: Good Review Practices Output Map and review IMDRF and APEC document Timeline 2020 – Discuss the documents 2021 – Draft the SEARN document 2022 – Adopt and get trained 2023 – Implement Milestone Adopted and implemented by SEARN Objective 4 – Collaboration Activity: Participate in Annual CRP workshop in Bangkok Nov 2019 Collaborative registration procedure (voluntary, reliance tool) Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK44 Training requirements Countries Training Maldives • Basic regulatory and quality requirements • Technical dossier review Thailand, Indonesia, Bangladesh and India • Review of technical dossier for IVDs kits of G6PD, Syphilis, Serum Creatinine, Hepatitis B Thailand • Clinical investigation • Pre-qualification program of WHO India • ADE reporting, recall and PMS evaluation • Patient registry of long-term implantable devices Indonesia, India • Clinical performance evaluation for IVDs • How to generate and evaluate stability data Technical discussion WHO Global Model Regulatory Framework for Medical Devices, including in-vitro diagnostic medical devices – Dr Gaby Henriette Vercauteren, Senior Adviser, Regulatory System Strengthening, WHO Headquarters, Geneva Dr Vercauteren highlighted that SDG 3 emphasises the promotion of health throughout the life-course and UHC. However, without proper regular regulation, it’s not possible to ensure quality of essential medicines and health products, including medical devices and IVDs. This has a critical bearing on achieving UHC. The work of WHO aims at supporting Member States build effective regulatory systems as essential components of not just health system strengthening but also contributing to better health care. She was pleased that there is a growing interest in medical devices as seen at the third SEARN meeting, where for the first time there is a WG on medical devices. She urged Member States to sustain this momentum. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 45 Dr Vercauteren informed that the following functions of NRA are assessed by using the GBT: ¤ National regulatory system ¤ Registration and marketing authorization ¤ Pharmacovigilance ¤ Market surveillance and control ¤ Licensing of premises ¤ Regulatory inspection ¤ Laboratory access and testing ¤ Clinical trial oversight ¤ NRA lot release GBT helps NRAs identify gaps and training needs; it is also a good incentive as it can be used as a tool to see how each NRA could improve its own regulatory systems. Dr Vercauteren shared that GBT has already been used for medicines and vaccines. A module has been developed for medical devices also and is ready for piloting. In this context, she said that the inputs of NRAs would be very valuable. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK46 Speaking about the Global Regulatory Framework, Dr Vercauteren said that they try to harmonise it with other actions that have been taken. The Global Harmonization Task Force (GHTF) has been instrumental in converging regulatory practice for medical devices; it has now been taken up by IMDRF. Dr Vercauteren also briefed the participants about the guiding principles of the Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices. Speaking about risk classification, Dr Vercauteren pointed out that it is based on the impact on public, health personnel and guided by a set of rules. There are some products that are classified differently in Europe or in the United States. She cited malaria and dengue as obvious examples. They are not considered as high public health risks or individual risk in those countries, but in this Region, these diseases do pose a high risk. Therefore, if there is an important product for malaria that has a CE mark, which is based on self-certification, it should be considered as a product that has undergone less scrutiny and will be not sufficient for a good overview. Improved regulatory practice through regional collaborative mechanisms – Enabling improved access to safe and effective medical products Dr Paul Huleatt, Director, Program Management Unit, Indo-Pacific Regulatory Strengthening Program, Therapeutic Goods Administration, Australia Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 47 Dr Paul briefed the participants about a new programme, which was initiated last year by the Therapeutic Goods Administration (TGA). Spanning both WPRO and SEARO, this is a five-year, AUD 300 million Health Security Initiative for the Indo-Pacific region launched by the Department of Foreign Affairs and Trade, Government of Australia. It has four components: 1. Promote global and regional cooperation 2. Catalyze international responses to countries on identified needs 3. Apply Australia’s strengths in health security 4. Accelerate access to new and effective tools The last component, ‘accelerate access to new and effective tools’ is where TGA can come in for regulatory strengthening. The program is centred on two components: 1. Strengthening the capability of NRAs in six countries in the Indo-Pacific region to increase the availability of safe and effective medicines and medical devices using malaria and TB as entry points; and 2. Enhancing coordination of stakeholders and regulatory system strengthening activities in the Indo-Pacific region. Dr Paul described the key components of the programme. Component 1: Strengthening the capability of target NRAs to increase the availability of safe and effective medical products This is done through developing strong institution-to-institution links with TGA and NRAs and in close cooperation with WHO Regulatory System Strengthening (RSS) programs at the global, regional, and country levels. TGA will deliver capacity development activities through a number of mechanisms: ¤ Regular visits to countries to help with strengthening the NRAs in the workplace; ¤ An on-call advice service to regulatory staff in NRAs, which is in regular contact through the Program Management Unit in Singapore and also through networks of people in TGA and NRAs in other countries on a regular basis; and Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK48 ¤ Provision of technical support to NRAs to build internal capabilities that will, where appropriate, allow participation of NRA staff in collaborative registration procedures. Component 2: Ensuring stakeholder coordination to promote regional collaboration on regulatory practice This will be taken up through appropriate regional platforms and forums, including WHO Coalition of Interested Partners (CIP), SEARN, WPRO Regional Alliance, RSP Forum. TGA will also enable NRAs in the region to use collaborative registration procedures e.g. WHO collaborative procedure Regulatory support for antimicrobial resistance Regulatory support to prevent and contain antimicrobial resistance – What actions should regulators take? – Dr Klara Tisocki AMR is an important concern for the public health authorities across the globe, especially in developing countries where relatively easy availability and higher consumption of medicines has led to disproportionately higher incidence of Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 49 inappropriate use of antibiotics and greater levels of resistance. The 2015 World Health Assembly adopted a global action plan on antimicrobial resistance, which outlines five objectives: 1. Improve awareness and understanding of antimicrobial resistance; 2. Strengthen surveillance and research; 3. Reduce the incidence of infection; 4. Optimize the use of antimicrobial medicines; and 5. Ensure sustainable investment in countering antimicrobial resistance. Dr Tisocki was happy to inform that every country in the SEA Region has a national action plan on AMR. She invited attention to the three main issues or the pillars that are important for the regulators as well as others working in the pharmaceutical sector and on medicine issues: 1. Improving antimicrobial awareness and understanding about AMR – This requires how these drugs are used through surveys and research. Surveys should also indicate how to deal with this problem. 2. Understanding the consumption and prescribing pattern as very often these factors drive resistance. 3. Optimising the use of antimicrobial medicine by making interventions to reduce overuse etc. e.g. in the animal sector or over the counter sale of antibiotics. Dr Tisocki highlighted the following issues for regulators to act on AMR: ¤ Raise awareness and promote responsible use Multiple agencies and multiple people from the NRAs, Ministries of Health, professional societies, academia all have a role in raising awareness and getting across the right messages to the public and to the prescribers on how they should use antimicrobials rationally. ¤ Ensure quality and supply chain security Preventing the entry of antimicrobials into the countries, including online sales which, is an important function of regulators. Through GMP inspections and by checking the quality of the products regulators, hold the manufacturer accountable for the quality of antimicrobials, whether those are imported or locally produced. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK50 ¤ Generate evidence to guide policy and research Many NRAs are already engaged in antimicrobial consumption surveys and starting to build up their own systems for this. ¤ Speed up R&D and access to new diagnostics and treatments This is about producing new medicines and diagnostics and getting those into the market quickly and having appropriate regulatory mechanisms that can protect efficacy of those new antibiotics so that resistance could be avoided. She also informed the participants about the new categorization of antibiotics in the WHO Essential Medicines List (EML) – Access, Watch and Reserve. Dr Tisocki gave a brief explanation about these categories: ¤ The Access group should be available at all times to treat commonly occurring infections. ¤ Watch group are the antibiotics recommended as 1st or 2nd choice for a smaller number of infection so their use should be more restricted. ¤ Reserve group should be the last resort options, when patients are admitted to ICU with very severe drug resistant infections etc. Regulatory support for Antimicrobial Resistance in India – Dr Madhur Gupta Dr Madhur Gupta shared the perspectives and activities on AMR in India. She stated that AMR has been amply highlighted in the National Health Policy of India 2017, which calls for stewardship programmes, standardisation of guidelines regarding antibiotic use, banning or restricting the use of antibiotics as growth promoters in animal livestock, limiting the use of antibiotics as over-the-counter medication. It also prescribes pharmacovigilance, including prescription audits in the facilities, hospitals, community and cultural, behavioural change to enforce change in existing practices. In India, the national response to containment of AMR started with setting up of the National Task Force in 2010, the Jaipur Declaration 2011, National Program for AMR established in 2012, followed by the AMR governance mechanisms, the Technical Advisory Group, the Core Working Group, the National Treatment Guidelines for Antimicrobial use in Infectious Diseases by NCDC, MoHFW followed by the launch of Inter-ministerial Consensus to achieve the National Action Plan on AMR and Delhi Declaration on AMR. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 51 Dr Madhur shared that the Government of India has issued a National Action Plan on AMR, which focusses on: ¤ Establishing a quality management system for supply chain management of antimicrobials; ¤ Strengthening governance to ensure uninterrupted supply of quality antimicrobials; and ¤ Monitoring safety of new antimicrobials through pharmacovigilance and strengthening regulations to eliminate substandard and falsified antimicrobials. The Technical Advisory Group on AMR (TAG-AMR) has established specific terms of reference; regulators are part of the TAG for monitoring AMR. A core working group (CWG-AMR) has also been established. The Drug Controller General of India is a member of the CWG-AMR. Dr Gupta shared that more states and provinces in India are getting active; she cited the Kerala AMR Action Plan as an example. In India, the rational use of antibiotics has been much in focus. For the over the counter sales of antibiotics, a strict implementation regimen of the Schedule H1 of the Drugs and Cosmetics Act and Rules is in place. The Drugs and Magic Remedies Act controls the advertisements. Revision of the normative documents, such as Indian Pharmacopoeia, the National Formulary etc. is underway. Enforcement is the key. Enforcement of Schedule H1 medicines includes 46 drugs out of which 24 are third or fourth generation cephalosporins and carbapenems and 11 are anti-tuberculosis drugs. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK52 Dr Gupta informed about the India’s ‘Red Line Campaign’, which was cited in the Review on Antimicrobial Resistance (launched in May 2016) as a model that could be used globally to counter the rising threat of antibiotic resistance. The ad poses the question: “Do you know? Medicines with a Red Line on the strip should never be consumed without a doctor’s prescription,” All antibiotics have a vertical red line. Dr Gupta shared that MoHFW, Government of India had also undertaken the largest ever scientifically designed, professionally executed national drug survey globally. The survey included a huge sample size of 47 954 drug samples relating to 23 dosage forms drawn from 654 districts of 36 states and union territories from the supply chains, including retail outlets, government sources and from eight airports and sea ports. Samples drawn from retail outlets were 33 656, and from the government sources 8369. Out of the 47 012 samples tested, 13 were found to be spurious and 1850 to be Steering group presentation Dr Reddy made a presentation on the discussions the Steering Group had taken up on Day 0. He stated that Steering Group has made the following suggestions: ¤ Potential new areas of opportunity for the WGs/Member NRAs. (i) Pharmaceutical abuse through internet sale, and (ii) Nutraceuticals/ dietary supplements. These new area can be agenda items for next SEARN meeting Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 53 ¤ Member States should identify training needs and share their strengths, best practices and support they can extend to other members. ¤ WHO may also provide assistance in compliance to the training needs identified. ¤ Repurpose existing molecules to encourage the use of established molecules where safety and efficacy is proven. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK54 7. CLosinG session The Rapporteur, Ms Aishath Mohamed presented the proposals for each Working Group. Her presentation included the recommendations of the Steering Group and Working Groups and their work plans. Final comments Indonesia Speaking on behalf of Indonesia Ms. Siti Asfijah stated that SEARN has been able to bring all NRAs closer and more open to each other. She suggested that WHO should identify areas that individual NRAs are stronger in terms of regulatory functions and create a talent pool so that it could be accessed by members for different expertise. Bangladesh Mr Ruhul Amin pointed out that many suggestions were brought in the discussions but the difficulty is with implementation. He suggested that NRAs should meet more frequently and work together closely to reach the goals in terms of quality human resources, quality products through achieving the highest possible maturity level. He also urged all NRAs to work hard to realise the recommendations of the SG and the 5 WGs. Thailand On behalf of Thailand, Mrs Korrapat Trisarnsri said that the deliberations of the meeting were very useful, especially in terms of sharing the expertise and knowledge among NRAs Maldives Ms Aishath Mohamed said that the SEARN platform has helped NRAs identify the gaps by working together and obtain support where necessary. She specifically mentioned that ISP is an excellent means for obtaining information for countries like Maldives, Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 55 Bhutan, Timor-Leste and to learn from other countries on how to strengthen their regulatory systems. She also stressed that all should work together to go forward and achieve the goals of SEARN. Mr Mike Ward Mr Mike was of the view that greater awareness should be created about the work that is being done by the NRAs through SEARN. He felt that the engagement of the industry, patients groups and other interested stakeholders is also important for the progress of the network. He congratulated the regulators and Dr Shridhar and the SEARO team for all the hard work and stated that the responsibility of taking the work forward finally rests with the regulators. Recalling the experience before the formation of SEARN, Mr Mike mentioned that some NRAs were not sure about the value of a network at the beginning but now there is consensus on the benefits of working together by getting to know one another better and trusting one another. ISP would be a great enabler in this context. Closing remarks by Dr Reddy The Chair, Dr Reddy said that his comments would be both as the Chair as well as on behalf of India. He was of the view that the three days were very productive and the technical discussions were most fruitful. Much has been already achieved but there are many things ahead, challenges as well as opportunities for the effective implementation of regulatory provisions in respective countries. He was confident that the NRAs will achieve their goals through this collaboration. Dr Reddy said he has four key messages for the network: (i) All NRAs should feel free to talk to each other; (ii) Willing to share information; (iii) Learn and adopt the best practices from other NRAs; and (iv) One day SEARN will be a brand for the Region and all medical products distributed in the Region will carry the SEARN logo indicating that those are quality assured medical products. Dr Reddy also thanked the Steering Group of the 3rd SEARN and the Working Group members for their excellent contribution to take SEARN to the next level. As informed by the Indonesian delegation, the 4th Annual Meeting of SEARN would be held in Jakarta, Indonesia in 2020 and he thanked the Indonesian Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK56 government for accepting to host it. He also informed that the next co-opted members of the Steering Group would be Bhutan and Nepal and extended a warm welcome to them. He thanked the Co-chair and the Rapporteur for their support and cooperation in conducting the 3rd SEARN meeting successfully. He also acknowledged the support of Dr Shridhar and the entire WHO team for efficient conduct of the meeting and hospitality. He appreciated the contributions made by all experts from various specialised institutions and those from the WHO HQ and SEARO. Vote of thanks by Dr Shridhar Proposing the vote of thanks, Dr Shridhar appreciated the participants for their support and enthusiasm in making possible a very successful meeting, specifically Dr Reddy, Chairperson of the third SEARN meeting for spending his valuable time. She appreciated the Co-Chair and the Rapporteur for their excellent contribution and thanked Maldives and Bangladesh for being available for teleconferences in spite of their other engagements. She thanked Indonesia for accepting to host the next SEARN 2020 meeting and welcomed Bhutan and Nepal to the Steering Group. She also thanked the entire WHO team, including the country office and WHO HQ. Dr Shridhar appreciated the support of the ministry officials. She invited all members to send their suggestions for the progress of SEARN. She specifically mentioned Dr Raj Long and Dr Gagandeep Kang for finding time to attend in spite of their busy schedules. Finally, she thanked everyone for their cooperation and contribution to make the meeting successful. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 57 Annex 1: Agenda Three days meeting: Day 0 (Satellite meeting), Day 1 – Day 2 1. Day 0 – Meeting of five Working groups before the meeting for face to face follow up on progress made in the TCs 2. Day 1 – Opening session 3. Presentation by five Working groups on activities taken up in 2018 and priorities for 2019, technical update and collaboration on regulation. 4. Regulatory engagement for anti-microbial resistance (AMR). 5. Discussion on strategic plan and resource mobilization for regulatory network. 6. Concluding session WGs facilitators will prepare training/ workshop schedule based on the inputs received by TCs of SG and WGs. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK58 Annex 2: List of participants Bangladesh 1. Mr Md. Ruhul Amin Director (c.c) Directorate General of Drug Administration Mohakhali Dhaka, Bangladesh 2. Dr Md. Akter Hossain Assistant Director Directorate General of Drug Administration Mohakhali Dhaka, Bangladesh 3. Mr Mohammad Nayeem Golder Assistant Director Directorate General of Drug Administration Mohakhali Dhaka, Bangladesh 4. Mr Md Harun Ur Rashid Superintendent of Drugs Drug Administration District Comilla, Chattagram Bangladesh 5. Mr Hossain Mohammad Imran Superintendent of Drugs Drug Administration Division Chattagram Bangladesh 6. Mr Md. Razibul Habib Superintendent of Drugs Directorate General of Drug Administration Mohakhali Dhaka, Bangladesh 7. Mr S.M. Sultanul Arefin Superintendent of Drugs Drug Administration Division Barisal Bangladesh Bhutan 8. Mr Kinga Jamphel Drug Controller Drug Regulatory Authority Royal Government of Bhutan Thimphu, Bhutan Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 59 9. Mr Jigme Tenzin Offtg. Chief Regulatory Officer Post Marketing Control Division Drug Regulatory Authority Royal Government of Bhutan Thimphu, Bhutan India 10. Dr S. Eswara Reddy Drugs Controller General (India) Central Drug Standard Control Organisation (CDSCO) New Delhi, India 11. Dr K. Bangarurajan Joint Drugs Controller General (India) Central Drug Standard Control Organisation (CDSCO) New Delhi, India 12. Mr Arvind Kukrety Deputy Drugs Controller Central Drug Standard Control Organisation (CDSCO) Zonal Office, Ahmedabad Gujarat, India 13. Mrs Swati Srivastava Deputy Drugs Controller (India) Central Drug Standard Control Organisation (CDSCO) New Delhi, India 14. Mr Ranga Chandrashekhar Deputy Drugs Controller (India) Central Drug Standard Control Organisation (CDSCO) New Delhi, India 15. Dr Ravikant Sharma Deputy Drugs Controller (India) Central Drug Standard Control Organisation (CDSCO) New Delhi, India 16. Dr V. Kalaiselvan Principal Scientific Officer Pharmacovigilance Programme of India (PvPI) Central Drug Standard Control Organisation (CDSCO) New Delhi, India Indonesia 17. Mr Lupi Trilaksono, S.F., Apt., MM Deputy Director of Class C and D Medical Devices Directorate of Medical Device and Household Products Evaluation Ministry of Health Jakarta, Indonesia Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK60 18. Ms Onne Widowaty, S. Farm., Apt. Head of Administration Section Directorate of Medical Device and Household Products Evaluation Ministry of Health Jakarta, Indonesia 19. Ms Siti Asfijah Abdoellah, S.Si.,Apt., MMed Sc Head of Sub directorate for Clinical Trial and Special Access Evaluation National Agency of Drug and Food Control (NADFC) Jakarta, Indonesia 20. Ms Nova Emelda, S.Si, Apt, MS Head Sub directorate for Generic Drug Registration National Agency of Drug and Food Control (NADFC) Jakarta, Indonesia 21. Ms Arlinda Wibiayu, S.Si.,Apt Head Section, of Data and Information Services National Agency of Drug and Food Control (NADFC) Jakarta, Indonesia 22. Ms Fera Ayu Dianovita, S.Farm., Apt In Vitro Diagnostics Product Evaluation Staff Directorate of Medical Device and Household Products Evaluation Ministry of Health Jakarta, Indonesia 23. Dra. Mirawati Siregar (Ms), Apt QC Senior Functional Staff National Agency of Drug and Food Control (NADFC) Jakarta, Indonesia Maldives 24. Mr Mohamed Fazeen Director Pharmaceutical Maldives Food and Drug Authority Male’, Maldives 25. Mr Abdul Raheem Adam Director Quality Assurance and Regulation Division Ministry of Health Male’, Maldives 26. Ms Aishath Mohamed Deputy Director General Pharmaceutical Maldives Food and Drug Authority Male’, Maldives Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 61 27. Mr Hassan Riyaz Assistant Director Regional and Atoll Health Services Division Ministry of Health Male’, Maldives 28. Mr Mohamed Abdul Ghanee Legal Officer Legal Affairs Unit Ministry of Health Male’, Maldives 29. Mr Hashim Aboobakuru Senior Biomedical Technician Regional and Atoll Health Services Division Ministry of Health Male’, Maldives Nepal 30. Mr Narayan Prasad Dhakal Director General Department of Drug Administration Bijuli Bazar, Kathmandu Nepal 31. Mr Pan Bahadur Kshetry Senior Drug Manager Department of Drug Administration Bijuli Bazar, Kathmandu Nepal 32. Ms Sangita Shah Drug Manager Quality Assurance and Regulation Division Ministry of Health and Population Ramshah Path, Kathmandu, Nepal Thailand 33. Mrs Korrapat Trisarnsri Director Medical Devices Control Division Food and Drug Administration Ministry of Public Health Nonthaburi 11000, Thailand 34. Mrs Tharnkamol Chanprapaph Acting, Expert on Drug Standard Food and Drug Administration Ministry of Public Health Nonthaburi 11000, Thailand Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK62 35. Ms Porntip Jiamsuchon Pharmacist, Senior Professional Level, Health Product Vigilance Center Technical and Planning Division Food and Drug Administration Ministry of Public Health Nonthaburi 11000, Thailand 36. Mrs Sirinmas Katchamart Pharmacist, Senior Professional Level Medical Device Control Division Food and Drug Administration Ministry of Public Health Nonthaburi 11000, Thailand 37. Mr Kritsada Limpananont Pharmacist, Professional Level System Development Division Bureau of Drug Control Food and Drug Administration Ministry of Public Health Nonthaburi 11000, Thailand 38. Mr Somsak Sunthornphanich Pharmacist, Senior Professional Level Bureau of Drug and Narcotic Department of Medical Sciences(DMSc) Ministry of Public Health Nonthaburi 11000, Thailand 39. Mrs Witinee Kongsuk Pharmacist, Senior Professional Level Bureau of Drug and Narcotic Department of Medical Sciences Ministry of Public Health Nonthaburi 11000, Thailand 40. Ms Patchareewan Phungnil Pharmacist, Professional Level Post-marketing Control Division Bureau of Drug Control Food and Drug Administration Ministry of Public Health Nonthaburi 11000, Thailand Timor-Leste 41. Mr Delfim da Costa Xavier Ferreira National Director for Pharmacy and Medicines Ministry of Health Dili, Timor-Leste Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 63 42. Mrs Apolonia Amelintje Gusmao Awoah Head of Regulation and Licensing of Pharmaceutical Activities Ministry of Health Dili, Timor-Leste 43. Mr Inacio da Costa Head of Department Authorization and Marketing Introduction of Pharmaceutical Product/Medicines Ministry of Health Dili, Timor-Leste Resource Persons/Temporary Advisers 44. Dr Nora Dellepiane QRB Consultants Sàrl Quality and Regulation of Biologicals Switzerland 45. Ms Chinta Abayawardana Independent Consultant Colombo, Sri Lanka 46. Ms Garima Singh Consultant Uttar Pradesh, India Other Organizations 47. Dr Raj Long Deputy Director Integrated Development, Global Health Bill & Melinda Gates Foundation 62 Buckingham Gate London SW1E 6AU 48. Dr Surinder Singh Director National Institute of Biologicals Plot No. A, 32, Institutional Area Block A, Industrial Area, Sector 62 Noida, Uttar Pradesh 201309 49. Dr Charles Gore Executive Director Medicines Patent Pool Rue de Varembé 7, Fifth floor 1202 Geneva, Switzerland 50. Dr Gagandeep Kang Executive Director Translational Health Science and Technology Faridabad, Haryana, India Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK64 51. Dr Alka Sharma Adviser / Scientist ‘G’ Medical Biotechnology Division Department of Biotechnology Ministry of Science & Technology, Government of India Lodi Road, New Delhi – 110003 52. Mr Paul Huleatt Director Program Management Unit Indo-Pacific Regulatory Strengthening Program (RSP) Therapeutic Goods Administration (TGA) Australian Government Department of Health PO Box 100, Woden ACT 2606 Australia 53. Mr Amit Srivastava CEO-Biovalley Incubation Andhra Pradesh Medtech Zone (AMTZ) AMTZ Campus,Visakhapatnam Andhra Pradesh, India 54. Mr Rishi Prakash Joint Director, e-Governance Centre for Development of Advanced Computing (C-DAC) Anusandhan Bhawan Noida, India 55. Ms Payal Saluja Joint Director, e-Governance Centre for Development of Advanced Computing (C-DAC) Anusandhan Bhawan Noida, India 56. Mr Neo Cherng Yeu Associate Director, Strategic Management Centre of Regulatory Excellence (CoRE) Duke-NUS Medical School 8 College Road Singapore 169857 57. Dr Chaitanya Kumar Koduri Associate Director International Public Policy Advocacy and Engagement United States Pharmacopeia – India (P) Ltd. Hyderabad, India Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 65 Secretariat WHO-HQ 58. Mr Michael Ward Coordinator Regulatory Systems Strengthening (RSS) Department of Essential Medicines and Health Products [EMP] Health Systems and Innovation World Health Organization, Headquarters Geneva, Switzerland 59. Dr Gaby Henriette Vercauteren Senior Adviser Regulatory Systems Strengthening (RSS) Department of Essential Medicines and Health Products [EMP] Health Systems and Innovation World Health Organization, Headquarters Geneva, Switzerland WHO-SEARO 60. Dr Phyllida Travis Director Department of Health Systems Development (HSD) WHO-SEARO, New Delhi 61. Dr Manisha Shridhar [Operational Officer] Regional Adviser Intellectual Property Rights, Trade and Health (IPT) Department of Health Systems Development (HSD) WHO-SEARO, New Delhi 62. Dr Klara Tisocki Regional Adviser Essential Drugs and Other Medicines (EDM) Department of Health Systems Development (HSD) WHO-SEARO, New Delhi 63. Mr Stephane Guichard Regional Advisor Vaccine Quality and Management (VQM) Department of Health Systems Development (HSD) WHO-SEARO, New Delhi 64. Dr Kim Sungchol Regional Adviser Traditional Medicines (TRM) Department of Health Systems Development (HSD) WHO-SEARO, New Delhi Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK66 65. Dr Aparna Singh Shah Regional Adviser Health Laboratory Services and Blood Safety Department of Communicable Diseases (CDS) WHO-SEARO, New Delhi 66. Ms Rita Gupta Executive Assistant Intellectual Property Rights, Trade and Health (IPT) Department of Health Systems Development (HSD) WHO-SEARO, New Delhi WHO Country Offices 67. Dr Henk Bekedam WHO Representative to India WHO Country Office for India New Delhi, India 68. Dr Madhur Gupta Technical Officer-Pharmaceuticals WHO Country Office for India New Delhi, India Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 67 Annex 3: Address by the regional director at the 3rd Annual meeting of south-east Asia regulatory network (seArn) 23–25 April 2019, New Delhi, India Ms Preeti Sudan, Secretary, Health & Family Welfare, Government of India; Dr Reddy, Drugs Controller General of India; Michel Ward, Coordinator, Regulatory Systems Strengthening; partners, national and international; representatives of National Regulatory Authorities; members of the South-East Asia Regulatory Network; WHO colleagues from Geneva, the Regional Office and Country Offices, distinguished participants, ladies and gentlemen, Welcome to the third Annual Meeting of the South-East Asia Regulatory Network. This meeting provides a crucial opportunity to meet, take stock of progress and plan ahead. I thank and commend all National Regulatory Authorities for their enthusiasm. The contributions you make will play a pivotal role in ensuring SEARN achieves its objectives and accelerates progress towards UHC – one of the Region’s Flagship Priorities, a core aim of WHO’s 13th General Programme of Work, and the key to reaching Sustainable Development Goal 3. UHC dominates today’s global agenda. WHO is committed to supporting SEARN enhance country cooperation, and in doing so, work towards sharing regulatory resources. These outcomes will be especially useful to the Region’s smaller countries due to the economies of scale they will have access to. Distinguished participants, The 2018 Delhi Declaration on Improving Access to Essential Medical Products, which ministers of each of the Region’s Member States endorsed, is unequivocal: We will “continue momentum to strengthen regulatory cooperation and collaboration to improve the availability, quality and safety of essential medical products through the South-East Asia Regulatory Network”. Let us take this opportunity to do precisely that, and build on the progress made at the second Annual Meeting in Colombo last year. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK68 As you urged at that meeting, the Information Sharing Platform, or ISP, Gateway has now been developed by the Centre for Development of Advanced Computing. At last year’s Regional Committee, ministers had an opportunity to see the ISP, which was operationalized the following month, in October. The Gateway is progressively expanding the data it stores across several key regulatory areas. As the ISP matures, I trust you will share alerts and confidential information to ensure quality medical products reach all people everywhere in our very large and diverse Region. I urge all of you to make full use of the ISP Gateway to sustain and accelerate progress, and thereby maximize SEARN’s innovative potential. That potential is well captured by SEARN’s five working groups, which support the overall objective of enabling communication and information sharing on regulatory policies, guidelines, standards, procedures, outputs and regulated products and entities. The first working group is concerned with quality assurance and the development and enforcement of medical product standards. I understand Working Group 1 has taken up mapping laboratory capacities as a priority. I am confident you will complete the task soon and overcome the non- availability of reference standards and impurities among some regulatory authorities. The second working group focuses on building capacity on regulatory practices. I urge Working Group 2 to fully leverage the strengths of regulatory authorities that already have robust Institutional Development Plans. I am pleased to learn that you are considering a pilot collaboration on the approval of new antiretrovirals to treat HIV/AIDS and hepatitis, which could significantly expand access to affordable generic medicines produced in the Region. The third working group’s focus can be summarized in a single word – vigilance. To that end, Working Group 3’s efforts to develop policies, norms, standards and guidelines for vigilance at the country level will be crucial. I encourage you to Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK 69 ensure the negative experiences of any regulatory authority is rapidly exchanged with others to protect public health and safety Region-wide. The fourth working group has helped shape the Information Sharing Platform, which has already been mentioned. I am pleased that at last year’s meeting you added a fifth working group, pertaining to medical devices and diagnostics. Working Group 5 is now building capacity in this area, keeping in mind country- specific needs and challenges, especially as they relate to diagnostics. To support and encourage this area of work, WHO organized a one-day pharmacovigilance programme to be held directly after this meeting. I thank the Andhra Pradesh Medical Technology Zone, Vishakhapatnam for their enthusiasm to host the event. I am sure Working Group 5 will make the most of the training. Distinguished participants, I understand you are actively engaged in developing a strategic plan that you will apply from the present year through to 2023. In doing so, I trust you will establish clear deliverables that will enable us all to gauge progress and focus where focus is needed. I cannot emphasize that point enough. The many partners gathered today are here to help, and I thank them for their presence. We all very much support this innovative initiative. As many of you are aware, WHO’s triple billion targets are both bold and ambitious. Your efforts to increase access to medical products are crucial to achieving them, and to staying on track to realize our own Flagship Priority and reach SDG 3 – to ensure healthy lives and promote health and well-being for all, at all ages. With that in mind, I am inspired by your enthusiasm and encouraged by the momentum SEARN has already gained. Third annual meeting of SOUTH-EAST ASIA REGULATORY NETWORK70 I am certain your collective wisdom and experience will contribute to the life- changing outcomes together we must achieve. I wish you an engaging and productive meeting. Thank you. Third annual meeting of New Delhi, India, 23–25 April 2019 South-East Asia Regulatory Network SEARN SOUTH-EAST ASIA REGULATORY NETWORK SEA- -HSD 397