WORLD HEALTH ORGANIZATION
REGIONAL OFFICE FOR
•
ORGANISATION MONDIALE DE LA SANTE
THE WESTERN PACIFIC
BUREAU REGIONAL OU PACIFIQUE OCCIDENTAL
REGIONAL COMMITTEE Thirty-fifth session Suva 5-11 September 1984 Provisional agenda item 13.1
WPR/RC35/8 10 July 1984 ORIGINAL: ENGLISH
CORRELATION OF THE WORK OF THE WORLD HEALTH ASSEMBLY, THE EXECUTIVE BOARD AND THE REGIONAL COMMITTEE Consideration of resolutions of the Thirty-seventh World Health Assembly and the Executive Board at its seventy-third and seventy-fourth sessions
Resolutions adopted by the Thirty-seventh World Health Assembly of interest for the work of WHO in the Western Pacific Region are hereby presented to the Regional Committee for comment, together with short analyses of their implications for Member States of the Region and for WHO's programme of cooperation. Resolutions directly related to other items on the provisional agenda of the current session of the Regional Committee form part of the documentation for those individual agenda items. A resolution adopted by the Executive Board at its seventy-third session in January 1984 is also included. Other resolutions of that session of the Board are reflected in the resolutions of the Health Assembly. Of the two resolutions adopted by the Executive Board at its seventy-fourth session in May 1984, none is of direct relevance to the work of the Regional Committee for the Western Pacific.
WPR/RC35/8 page 2
1.
Prevention and control of vitamin A deficiency and xerophthalmia (resolution WHA37.18) Attention is drawn to operative paragraphs 2 and 3.
Vitamin A deficiency and xerophthalmia are a problem in Fiji, Lao People's Democratic Republic, Papua New Guinea, the Philippines, VietNam and to a lesser degree in other developing countries of the Region, although attempts to assess the magnitude of the problem in these countries have been hampered by lack of accurate data. Efforts to deal with this problem in the Region in the past have mainly taken the forrn of nutrition education, periodical supply of high dosage vitamin A capsules to pre-school children and attempts to fortify foods with vitamin A. The feasibility of fortifying monosodium glutamate with retinol was tested in three provinces in the Philippines. This WHO-supported study demonstrated the feasibility of this method. Member States will need to give high priority to the prevention and control of vitamin A deficiency and xerophthalmia through appropriate nutritional programmes in the context of primary health care. lnitiaUy, action should be taken to quantify the extent of the problem and to develop an appropriate nutrition programme, which wit 1 include nutrition education, identification of children at risk, and administration of high doses of vitamin A at periodic intervals. It will be noted from operative paragraph 3 that the Director-General has been requested to collaborate with Member States in monitoring the incidence and prevalence of these problems and in assessing the most appropriate approaches. WHO is already supporting countries in their efforts through its programmes on nutrition and prevention of blindness. Further support could be extended to countries at their request, subject to availability of resources. 2. Collaboration within the United Nations s stem - General matters: Abuse of narcotic and psychotropic substances resolution WHA37.23 Attention is drawn to operative paragraph 1. Member States are invited to implement in its entirety resolution WHA33.27, which covers inter alia the following aspects of drug abuse control by Member States: (a) devoting more attention to the incidence of drug abuse in their societies; (b) (c)
incorporating into their national health-for-aU strategies components to deal effectively with the growing incidence of drug abuse; making voluntary contributions to support work in the field of drug abuse control by WHO and other international bodies; becoming parties to the international drug control treaties as soon as possible if they have not already done so;
(d)
Member States are further requested to explore new methods for the prevention and treatment of drug addiction and to improve information on this problem.
WPRJRC35/8 page 3
WHO will continue to promote the initiation and strengthening of national programmes on drug abuse, and to further develop activities concerned with the prevention and control of health problems related to human behaviour, such as those linked to drug abuse. 3. International standards and units for biological substances (resolution WHA37.27)
Attention is drawn to the recommendations under part I and part II, operative paragraph 3. This resolution, which recommends the adoption of certain international standards and units for biological substances, is an important step in further improving the quality and control of biological products at national level. The resolution recommends official recognition of the international standards and international reference preparations and units for biological substances enumerated in the annexes to the resolution. The Director-General for his part is invited to inquire how these are being utilized by Member States in the control of biological products. Although the majority of Member States are aware of the value and utility of the international units defined for international reference preparations of biological substances, every effort should be made to ensure that these standards and units are recognized in the national pharmacopoeias. In countries where national standards are not available, local authorities will be encouraged, where necessary, to express the potency of their products in international units. Member States will need to develop adequate mechanisms for the quality control of biological substances, based on the international standards and units for biological substances. WHO will continue to cooperate in establishing and strengthening national quality control laboratories. Continuous training in advanced quality control techniques, including the utilization of international biological standards and reference substances, will be necessary. Efforts will also be needed to increase the availability of reference substances, including biological standards. 4. Infant and young child nutrition (resolution WHA37 .30) Attention is drawn to operative paragraph 2. The subject of infant and young child nutrition is receiving close attention in the Kegion. In accordance with resolutions WHA34.22 and WPR/RC32.RI I, a report on action taken in the field of infant and young child nutrition and on the status of implementation of the International Code of Marketing of Breast-milk Substitutes was presented to the Regional Committee at its thirty-fourth session. The next progress report will be presented during the thirty-sixth session of the Regional Committee in 1985.
WPR/RC35/8 page 4
Progress has been noted both with regard to the promotion of breast-feeding and the development of appropriate legislative or other measures to control the use of breast-milk substitutes. World Health Assembly resolution WHA37.30 urges all Member States to continue their efforts to improve infant and young child feeding, with particular emphasis on the use of local foods. While most countries or areas in the Region have been taking measures to comply with the recommendations of the World Health Assembly and the Regional Committee as well as the International Code of Marketing of Breast-milk Substitutes, increased efforts will be needed in this particular field. The progress reports received from Member States during 1984 were forwarded to WHO Headquarters to form the basis of the report of the Director-General. WHO will continue to intensify its collaboration with Member States in this particular area within the overall programme on nutrition. 5.
Action programme on essential drugs and vaccines (resolution WHA37.32) Attention is drawn to operative paragraphs 2, 3 and 5.
Member States which have not yet done so are urged to intensify their action to develop drug policies as part of their comprehensive hea.lth policies. Such drug policies should aim at increasing the availability of safe and effective drugs of adequate quality, by providing for the selection and proper use of essential drugs, i mprovernents in the production and supply systems, and the establishment of drug evaluation and quality assurance mechanisms. Staff training is a key factor in successful implementation, and will need to be intensified by Member States. Cooperation among Member States also needs to be strengthened. Activities in relation to technical cooperation in pharmaceuticals among ASEAN countries will continue to be further developed. WHO for its part must play a more vigorous role as coordinating and technical cooperation agency. It will be noted that the Regional Committee is urged to review progress periodically and to report thereon to the Executive Board. Steps have been taken to prepare for this review, which will be undertaken at a forthcoming session of the R.egional Committee. 6. Rational use of drugs (resolution WHA37.33) Attention is drawn to operative paragraphs 1 and 2. This resolution, which aims to improve the use of drugs and prescription practices, urges Member States inter alia to support the development and dissemination of unbiased and complete drug information and the exchange of information on the use and marketing of drugs and to strengthen national capability in the selection and proper use of drugs to meet real national needs.
WPR/RC35/8 page5
More attention will need to be given to the development of programmes for the exchange of information on the use and marketing of drugs, through bilateral as well as multilateral collaboration. In this connexion, it will be noted that the Director-General has been requested to arrange in 1985 a mu1tisectora1 meeting of experts to discuss means and methods of ensuring the rational use of drugs. The results of this meeting may provide new dimensions to be taken into consideration when the 1986-1987 programmes, especially the intercountry programmes, come to be implemented. 7. International Programme on Chemical Safety (resolution EB73.Rl0) Attention is drawn to operative paragraphs 1 and 2. Member States are urged to establish national focal points for the Programme and appropriate mechanisms for coordinating work related to chemical safety, and to identify, where possible, national institutions to collaborate with the Programme. In the light of their health priorities, institutional capacity to implement national programmes should be strengthened and provided with the necessary resources. Epidemiological studies should be conducted in cooperation with WHO to identify chemicals or combinations of chemicals and physical and biological factors which are detrimental to health and the environment. Where the necessary scientific and other facilities exist, national programmes should be developed to promote evaluation of the risk of chemicals. Programmes for the control of toxic and hazardous chemicals from manufacturing source to final disposal should be developed to minimize the risk to health and the environment, subject to the availability of resources. WHO will continue to cooperate in promoting national programmes and developing institutional capability. Activities for the control of toxic and hazardous wastes will be given support at national leve 1. Close coordination will be promoted with other WHO programme areas and Member States, including the transfer of information derived from relevant epidemiological and toxicological studies. Priority should be given to ensuring coordination with UNE.P and ILO in programme implementation, including mobilization of all possible sources of support.
THIRTY-SEVENTH WORLD HEALTH ASSEMBLY Agenda item 20
WHA37.18 16 May 1984
PREVENTION AND CONTROLOF VITAMIN A DEFICIENCY AND XEROPHTHALMIA The Thirty-seventh World Health Assembly, Recalling resolutions WHA22.29, WHA25.55 and WHA28.54 on the prevention of blindness: Recognizing the continuinggreat human suffering, and the considerable burden to both the individual and to society that is caused by nutritional blindness; Considering that, in Asia alone, more than ten million children are affected by vitamin A deficiency and xerophthalmia; that more than one million of these become blind every year; that as many as seventy per cent. of this number die ~n the weeks immediately following the onset of blindness; and that the remainder are permanently blind; Conscious that even mild cases of vitamin A deficiency and xerophthalmia contribute to increased morbidity and mortality in young children in many developing countries; C.onsidering that vitamin A deficiency and xerophthalmia are highly prevalent in Africa, Asia and the Western Pacific, and in limited areas of the Americas; Aware that safe, effective and relatively inexpensive techniques exist to control vitamin A deficiency and xerophthalmia, in particular increased consumption of local foodstuffs rich in provitamin A, through periodic mass distribution of large doses of vitamin A, and the fortification of certain foods; 1.
THANKS the Director-General for the updated information on selected global and regional trends in nutritional status and related i~dicators included in his report;
2. URGES all Member States to give high priority to the prevention and control of vitamin A deficiency and xerophthalmia wherever these problems exist through appropriate nutritional programmes as part of primary health care; 3. REQUESTS the Director-General: (l) to give all possible support to Member States, as and when requested, in assessing the most appropriate approaches, in the light of national circumstances, needs and resources, to preventing and controlling vitamin A deficiency and xerophthalmia; (2) to collaborate with Member States in the monitoring of the incidence and prevalence of vitamin A deficiency and xerophthalmia; (3) to prepare suitable materials, for adaptation and use at the national level, for training health workers and development workers in the prevention of vitamin A deficiency, particularly through education in nutrition and by promoting the production of local foodstuffs rich in provitamin A, and in the early identification and treatment of vitamin A deficiency;
WBA37.18 page 2 (4) to coordinate with other intergovertl11lental organizations, and appropriate nonaovernmental organizations, the launching and management of intensive and extensive international action to c - a t vitamin A deficiency, including the mobilization of financial and other resources required for such actions; (5)
to report to the World Health Assembly on progress in this area.
Thirteenth plenary meeting, 16 May 1984 A37 /VR/13
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THIRTY-SEVENTH WORLD HEALTH ASSEMBLY
WHA37.23
Agenda item 33.1
17 May 1984
COLLABORATION WITHIN THE UNITED NATIONS SYSTEM:
GENERAL MATTERS
Abuse of Narcotic and Psychotropic substances The Thirty-seventh World Health Assembly, Recalling resolution WHA33.27 on the abuse of narcotic and psychotropic substances, adopted by the Thirty-third World Health Assembly in May 1980, and resolution EB73.Rll on the same subject; Recognizing the dramatic global increase in drug addiction, particularly to cocaine, all the more alarming in that the young are the chief victims of narcotics dependence; Considering that the efforts made by the different countries to combat and prevent drug addiction have been insufficient and that WHO is the agency which, by virtue of its responsibility for the health of the population, has an important role to play in stimulating more effective national efforts; Noting with satisfaction that development of the WHO global programme on drug dependence, I. INVITES Member States to implement in its entirety resolution WHA33.27 of Hay 1980 and to combine their efforts in exploring new methods for prevention and treatment of drug addiction and improving information on this problem;
2.
REQUESTS the Director-General: (l) to seek extrabudgetary resources to permit WHO to strengthen epidemiological surveillance systems in this field; (2) to continue his collaboration in the spirit of resolution WHA33.27 and report to the next World Health Assembly of the progress. achieved in this sector; (3) to include this item in the agenda for the Thirty-ninth World Health Assembly in 1986. Fourteenth plenary meeting, 17 May 1984 A37/VR/14
TIIIRTY-SEVENTH WORLD HEALTH ASSEMBLY Agenda item 21
WHA37 .27
17 May 1984
INTERNATIONAL STANDARDS AND UNITS FOR BIOLOGICAL SUBSTANCES The Thirty-seventh World Health Assembly, Considering Articles 2(u), 2l(d) and (e) and 23 of the Constitution; Considering resolutions WHA3.8, WHA18.7 and WHA26.32 adopted by the Third World Health Assembly, the Eighteenth World Health Assembly and the Twenty-sixth World Health Assembly respectively, recoomending the adoption of certain international standards and units for biological substances; I
REC<HlENDS (l) that Member States of the Organization recognize officially the international standards and international reference preparations and units for biological substances enumerated in the two lists annexed to this resolution, 1 which supersede the lists recommended in resolutions WHA3.8, WHA18.7 and WHA26.32; (2) that these standards and units or their equivalents be cited in the relevant national pharmacopoeias; (3) that, where applicable, these standards and units or their equivalents be recognized in relevant national regulations; (4) that in those countries which do not possess a national pharmacopoeia or national "standards, when it is. necessary that the potency of the product should be stated on the label, such potency be expressed in international units; II
Considering also the need to make these international biological standards available Member States in the most expeditious and convenient manner, as a contribution towards enabling an acceptable level of quality of biological substance s used in medicine to be achieved; t~
Recognizing the · v~ii-lue and utility to Member States of these international units, as well as of international units defined for a number of international reference preparations of biological substances, in the national control of biological products; AUTHORIZES the Director-Genera 1, where necessary for the use of regulatory agencies Stlltes, to make addition~ to or replacements of these international biological preparations. subject in each case to the satisfactory completion of the technical procedures now established of international collaborative studies and assays and under the advice of the members of the Expert Advisory Panel on Biolqgical Standardization or other experts designated to deal with the standardization of ~articular biological substances; I. Me~mbcr
••I
WHA37 .27 pege 2
2.
REQUESTS the Director-General to inform Member States periodically when such international biological preparations are established and their international Llnits have been defined ;
3. INVITES the Director-General to inquire periodically of Members regarding the use being made of these international standards and other biological preparations in their countries in the control of biological products.
Fourteenth plenary meeting, 17 May 1984 A37/VR/14
THIRTY-SEVENTH WORLD HEALTH ASSEMBLY Agenda item 20 INFANT AND YOUNG CHILD NUTRITION The Th irty-aeventh World Health Asse~J~bly,
WHAJ7.30 17 May 1984
Recalling resolutions WHA27.43, WHA31.47, WHA33.J2, WHA34.22, WHA35.26, which dealt with infant and young child feeding; Recognizing that the implementation of the International Code of Marketing of Breast-milk Substitutes is one of the important actions required in order to protect healthy infant and young child feeding; Recalling the discussion on infant and young child feeding at the Thirty-sixth World Health Assembly, which concluded that it was premature to revise the International Code at that time ; Having considered the Director-General's report,l and noting with interest its contents; Aware that many products unsuitable for infant feeding are being promoted for this purpose in many parts of the world, and that some infant foods are being, promoted for use at too early an age, which can be detrimental to infant and young child health ;
1.
ENDORSES, the Director-General's report;
2. URGES continued action by Member States, WHO, nongovernmental organizations and all other interested parties to put into effect measures to improve infant and young child feeding, with particular emphasis on the use of foods of local origin; 3. REQUESTS the Director-General: to continue and intensify collaboration with Member States in their efforts to implement and monitor the International Code of Marketing of Breast-milk Substitutes as an important measure at the national level; ( 1)
(2)
to support Member States in examining the promotion and use of foods unsuitable for infant and young child feeding, and the promotion of the appropriate use of infant foods;
(3) to report to the Thirty-ninth World Health Assembly on the progress in implementing this resolution, together with rec;ommendations for any other measures needed to further improve sound infant and young child feeding practices.
Fourteenth plenary meeting, 17 May 1984 A37/ VR/14
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Document A37 6. =
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THIRTY-SEVENTH WORLD HEALTH ASSEMBLY Agenda i te! 22
WHA37 .32 l7 May 1984
ACTION PROGRAMME ON ESSENTIAL DRUGS AND VACCINES The Thirty-seventh World H~alth
Asembly,
Recalling previous resolutions of the Health Assembly on this matter, and in particular resolution WHAJ5.27, in which the main lines of the Action Programme on Essential Drugs for the . c~ng years and the plan of action for 1982 and 1983 were endorsed, subject to the Health Assembly's deliberations; Having reviewed the Executive Board's report on the Action Programme on Essential Drugs and Va~cines; Satisfied that the Programme is making progress along the lines endorsed by the Thirty-fifth World Health Assembly; Noting with satisfaction that Member States, development agencies, the pharmaceutical industry and a number of other partners are increasingly responding to the challenge of the Progr8DIIle; Welcoming in particular the close collaboration between WHO and the United Nations Children's Fund in carrying out the Programme; Recognizing at the same time that a number of major issues remain to be resolved; 1.
ENDORSES the Executive Board's report; URGES Member States; (1) to intensify their action to introduce and implement drug policies along the lines endorsed by the Thirty-fifth World Health Assembly in resolution WHA35.27; (2) to intensify training of personnel to achieve the objectives proposed by the Programme; (3) to strengthen cooperation among themselves for the implementation of the Programme; committees~
2.
3.
URGES the regional
(1) to encourage Member States in their region to give support to the Programme along the lines endorsed by the Thirty-fifth World Health Assembly; (2) to ensure adequate resources in their regional programme budgets to support Member State& in their efforts; (3) to review periodically progress in itnpleme.nting the Programme in their r .e gion and report thereon to the Executive Board;
WHA37 .32
page 2 4. REQUESTS the Executive (1) (2) (3) 5. Board~
to continue to review closely progress in implementing the Prograume; to study major outstanding issues and define principles for resolving them; to report periodically to the Health Assembly on the above;
REQUESTS the Director-General: (1) to intensify WHO's technical cooperation with Member States that so desire in implementing national drug policies in conformity with the Programme; (2) to facilitate technical cooperation among countries in carrying out the Programme and specific components of it; (3) to foster coordinated action, including research, among all partners involved throughout the world in order to ensure the most effective and efficient implementation of the Programme; (4) to continue to ensure that adequate resources are provided to implement the Programme and to attract extrabudgetary funds to the programmes of developing countries; (5) to monitor and evaluate the Programme on a continuing basis;
(6) to continue to report periodically to the Executive Board on progress achieved and problems encountered. Fourteenth plenary meeting, 17 May 1984 A37/VR/14
THIRTY-SEVENTH WORLD HEALTH ASSEMBLY Agenda item 22
WHA37.33 17 May 1984
RATIONAL
US~
OF DRUGS
The Thirty-seventh World Health Assembly, Recalling resolutions WHA24.56 and WHA31.32; Recognizing the progress . ach,ieved . in the development: of the WIJO Action Progranme . on Essential Drugs, the Organizado.n's progra111111e on .drug infort~~ati(m.and other WHO activities in this field; Concerned by the high proportion of health budgets spent on drugs in many countries, particularly in developing countries, thereby limiting the remaining funds available for the provision of adequate health care to the whole population through primary health care; Realizing the problems of inappropriate and excessive prescription and use of drugs; Aware of the need for further studies, inter alia, in clinical pharmacology, to faciliate the improvement of prescription practices, with regard to effects, adverse reactions and the possible interaction of drugs; Realizing the need for better knowledge of actual drug consumpt i on and prescr i ption practices; Aware of the importance of training of health personnel to ensure the appropr i ate use and prescription of drugs; Recognizing the importance of unbiased and complete information about drugs to health authorit i es, physicians, pharmacy staff, other health workers and the general public; Aware of the need for better information on drug marketing procedures and practices; Recognizing the achievement of local drug and therapeutic COIIIDittees established in several Member States; Noting with satisfaction the growing interest shown by governments, regi s tra t i on authorities, the pharmaceutical industry, patients' and consumers' organiz;ations and health workers in information about, and the marketing of, drugs; Convinced of the need for cooperation between all interested parties 1.n order to achieve a more rational use of drugs; URGES Member States: (1)
to support the development and dissemination of unbiased and complete drug information;
(2) to collaborate in the exchange of information on the use and maTketing of drugs through bilateral or multilateral programmes and WHO;
(3) to strengthen the national capabilities of developing countries in the selection and proper use of drugs to meet their real needs and in local production and quality control, Wherever f easible, of drugs;
(4) to intensify action to introduce and Uaplement comprehensive and rational drug policies;
WHA37.33 page 2
2.
REQUESTS the Director-General: (1) to continue to develop activities at naticmal, regional and global levels aiming at the improvement of use of drugs and of prescription practices and the provision of unbiased and complete information about drugs to the health profession and the public;
(2) (a) to foster the exchange of information among Member States on drugs including registration and marketing practices; (b) to review the machinery within WHO concerning the dissemination of unbiased information relevant to the appropriate use of essential and other drugs; and to introduce appropriate improvements therein; gover~nts,
to arrange, in 1985, a meeting of experts of the concerned parties, including pharmaceutical industries, patients' and consumers' organizations to discuss the means and methods to ensure rational use of drugs, in particular through improved knowledge and flow of information and to . discuss the role of marketing practices in this respect, especially in developing countries;
(3)
(4) to subJDit a report on the results of the meeting of experts and the implementation of this resolution to the Thirty-'ninth Wot'ld Health A~sembly.
Fourteenth plenary meeting, 17 May 1984 A'37/VR/14
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Seventy-third Session Agenda item 16 INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY The Executive Board,
EB73.Rl0 19 January 1984
Recalling resolutions WHA30.47, WHA31.28 and EB63 .Rl9 on the evaluation of the effects of chemicals on health; Having considered the report of the Director-General 1 on the International Programme on Chemical Safety; Stressing the importance of using chemicals in an environmentally sound manner; Recognizing that the international trade in chemicals is worldwide and increasingly involves developing countries; Aware that the use of chemicals and the pollution of the environment that can result from it do not recognize national boundaries and that it is essential to protect human health and the environment from the adverse effects of chemicals; Noting the progress already made in achieving the goals set for the Programme by the Executive Board in resolution EB63.Rl9; Noting further that the Progratlllle is now established as a collaborative activity with the active participation of Member States and that memoranda of understanding have been signed on the one hand with 17 Member States for their active participation in the Programtne and on the other hand between the United Nations Environment Progratlllle, the International Labour Organisation and WHO, to make this Progra'IQIIle a broad international effort enabling it to address both human health and environmental aspects; Noting also that collaboration has been established with the Commission of the European C0111111unities, the Council for Mutual Economic Assistance and the Organization for Economic Cooperation and Development; Recognizing the need for increased extrabudgetary resources, to allow flexible long-term prograa.e development in the light of internationally agreed priorities and ensure continuity of staffing for effective implementation of the Programme; l. RECOMMENDS that Member States; (1) consider establishing national focal points for the Programme in the light of their health priorities, if they have not yet done so, as well as appropriate mechanisms for coordinating work related to chemical safety; and that those in a positton to do so identify national institutions to collaborate with the Programme and provi_ de them with the necessary resources for this purpose;
1
Document EB73/20.
!B73 •.R10 page 2
(2)
cap~city
euuu to tile best of their economic ability the availability of institutional to bapleaent chemical •afety measures such as those recommended by the
'rro gT 8JIDe ; (3) cooperate with WHO in conducting epidemiological studies with a 'il'iew to identifying those chemicals, acting singly or in combination, or combinatio. n s of chemicals and physical and biological factors, which may be detrimental to health and the environment;
(4) consider, where the necessary scientific and other facilities exist, developing national toxicological programmes as a means of promoting comprehensive evaluations of the risk of chemicals to health and the environment; (5) consider, if they are in a position tp do so, increasing their voluntary contributions to the Programme from all relevant sources, in a manner which allows flexible and long-term programme development; 2. REQUESTS the Director-General: (1)
to develop the Programme further along the lines proposed in his report;
(2) to further encourage the active participation of ·developing countries in the Programme; (3) to give particular attention to : (a) short- and long-term priorities on the basis of the needs of all Member States;
(b) measures to cooperate with Member States in implementing the Programme, including the development of manpower and institutional capacity; (c) ensuring close coordination within the Programme and between it and other WHO programmes concerned at national, regional and global levels, including the application by those programmes of the evaluated informatioQ arising from the Prograume; (4) to encourage the increasingly active involvement in the Programme of all the WHO regional offices with a view to strengthening the technical cooperation with Member States with respect to chemical safety; (5) to give priority to continuing, together with UNEP and ILO , negotiations with FAO with a view to its joining this cooperative Programme; (6) to explore, with UNEP, ILO and the donors, what efforts can be made to place funding for the Programme on a continuous long-term basis; (7) to seek support for the Programme from all other possible sources in a manner which guarantees its international charac t er and independence; (8) to modify the organizational structure of the Progra11111e as proposed in section 4 of his report; (9) to report to the Board at the seventy-seventh session on progress made 1n implementing the Programme.
Thirteenth m eet i ng, 19 January 1984 EB73/SR/13
WllAJ J ,.2 7 P4i&tt J ANNEX
LIST I. ANTIBIOTiCS (held in London) !U per ampoule
BIOLOGICAL STANDARDS
mg,hu (if
Years of eat.a.bli&hme-nt Form in which ayail<>i>le (in: bracket I, weisht of previ<'H
Prepar~tion
relevant)
ltiJndatd c.onta1n1n& one lU) Ampoulos containing approximately 50 mg of amphotericin B (940 IU per mg) Ampo~les
Amphotericin B
0.001064
lot Standard 1963
~ I
Ba c i t rae in
0.01351
containing approximately 100 mg of zinc. bacitracin (74 IU per mg)
lot Standard 1953 (0.018?. mg) 2nd Standard 1964 lst Standard 1953 (0;001 ma) 2nd Standard 1969
Chlortetracycline
-
0.001
Ampoules containing approximately 75 mg of chlortetracycline hydrochloride (1000 IU per mg) Ampoules containing approximately 75 mg of coliotin a.ulfate (20 500 lU per mg) Ampoules containing approximately 200 mg of dihydrostreptomycin sulfate (820 IU per mg)
I i
Co listin
0.00004878
lst Standard 1968
Dihydrostreptomycin
0.001219
lst Standard 1953 (0 .001316 mg) 2nd Standard 1966
Erythromycin
0.001087
Ampoules containing approximately 7 5 mg of erythromycin A base (920 IU per mg)
lst Standard 1951 (0.001053 ..~) 2nd Standard 1978 tst Standard 1965
No vobiocin
-
0.001031
AD,tpoules containing approx~tely 100 rtig of novobi ocin acid (970 IU per mg) AmpO\Iles conl.aining .3pprox.imately 100 mg of nyetatin (4855 IU per mg) Ampoules containing approximately 7S mg of oleandomycin chloro form addUct (850 IU per mg )
Nys c .lt i ll
0.00020~9
lot Standard 1963 (0.000133 2nd St <~. nd.ard 1982
r.1g)
Oleandomycin
O .OOll76
lst Standard 1964
lJxy tetracycline
0.0011364
Ampoules containing approximately 100 mg of oxytetrOJ.cycline base dihydrate (880 Ill por mg) Ampoules con t aining approximately 75 mg of purified polymyxin B sulfate (8403 . IU per mg)
1st S tandard 1955 (0.00111 Ill&) 2nd Standard 1966
P<.)lymyxin B
-
0.000ll9
1st Su:nctard 1955 (O,O(JQ\27 mg) 2nd Standard.. 1969
Ro l i.tctracyctine
0.001004
Ampoules containi.ng approxi.t:Dately 100 mg of rolitccr~cyclini' (996 IU per mg) Ampoules containing 100 mg of mycin sulfate strepto~
Is< Scanda'd l968
Streptomycin
78 500
lot Standard 1950 (o.oo1282 mal Znd Standard 1958 Jrd Standard 191ll
Te tracycline
-
0.00101833
Ampoules con .t ainin& approximately 75 mg of tetracycline hydrochloride (982 lU per mg)
lot Stan.U.rd 19S7 (o,ool01 ..,, Znd Stac>dard 1970
Vancomycin
0.000993
Ampoules containing approximately SO mg of vancomycin sulfate (1007 lU per mg)
1at Standard 1963
ANTIBIOTICS (held in Weybridge) Hygromycin B 0.0008928 Ampoules containing 40 mg of hygromyc in B (llZO IU per mg) Ampoules .containing 40 mg of tylosin baee (1000 IU per mg) lot Staadar.!J. 1966
Tylosin
0.001
ANTIBODIES (held i.n Copenhagen)
Anti -dysentery serum (Shiga), equine
0.05 (of dry material
Bottlt:s containing 10 ml ,>f a solution of dried hyperimnme horse serum - in saline
lst Standard 192S
containing 66"~ v/v of glycerol (200 IU
in stock ampoules) Anti~poliovirus
per ml)
serum (type l) , monkey
10
Ampoules containing 107.8 mg of dried hyperitmtune monkey serum Ampoules containing 104.6 mg of dried hyperinrm.me monkey serum Ampoules c ontaining 104.8 mg of dried hyperimmune monkey serum 0.1017 Ampoules containing 101 . 7 mg of driP.d bovine serum (T 121.) ~poules
let Standard 1962
Anti-poliovirus serum (type 2), monkey Anti-poliovirus serum (type 3), monkey
10
10
Is t S taadard 1962
Anti-Q-fever serum, bovine
1 000
1st Standard 1953
Anti-rabies serum, equine
86.6
1.0
-contaip.ing 86.6 mg of dried hyperinJnUne horse serum (! 5.3%)
let Standard 19SS
Anti-smallpox seruJD, human
1000
Ampoules containing 84.3 mg of freezedried pool ed human serum ~poules
l»t Standard 1965
Antiwstreptoly5in 0,
hu~nan
2 160
containing 4& mg of dried human iierum; distr~buted as a 10 ml solution containing 10 IU per ml
lH Standard. 1959
WIIA37.27 page 4
~ ANTIBODIES (held in Copenhagen) (continued)
LIST I.
BIOLOGICAL STANDARDS (continued)
IU Preparation per Ampoule 2 000
ms/IU (if
Form in which available
re\eVant) Ampoules containing 17 5. 8 mg of freezedried pooled human serum Ampoules containing 68.0 mg of dried hyperinmune ho't'ile serum Ampoules containing 87 .0 mg of dried hyperilxlnune horse serum Ampoules containing 80.0 mg of dried hyperi111nune horse serum
Years of establishtllent (in brackets, weight of previous standard containing onf! IU) 1st Standard 1967 2nd Standard 1980
1
Anti-toxoplasma serum, human
Clostridium botulinum Type A antitoxin, equine Clostridium botulinum
500
500
1st Standard 1963
Type B anti toxin. equine Clostridium botulinum Type C antitoxin, equine Clostridium botulinum
1 000
1st Standard 1963
1 000
Type D antitoxin, equine Clostridium botulinum l 000
Ampoules containing 12.1 mg of dried hyperil'llnune horae serum Ampoules containing 69.1 mg of dried hyperiDinune horse serum Ampoules containing 29.32 mg of dried hyperiTI'ItlUne rabbit serum
1st Standard 1963
1st Standard 1963
Type E antitoxin, equine Clostridium botulinum Type F antitoxin, rabbit Diphtheria antitoxin, equine
4
1st Standard 1965 1st Standard 1934 1
-
0.0628 (of dry material in stock ampoules) 50 0.2
Ampoules containing approximately 476 mg of dried hyperimmune horse serum; distributed in bottles containing 10 ml of solution of the dried serum containing 667, of glycerol (10 IU per ml)
v/v
Gas-gangrene antitoxin (Clostridium histolyticum) equine
Ampoules containing 10.0 mg of freezedried hyperimmune horse serum
1st Standard 1935 (0.3575 mg) 2nd Standard 1951 (0.2 mg) Jrd Standard 1971 1st Standard 1934 (0.2681 mg) 2nd Standard 1952 (0.1135 mg) 3rd Standard 1966 lst Standard 1934 (0.2377 mg) 2nd Standard 1947 (0.097'• mg) 3rd Standard 1957 lst Standard 1938
Gas -gangrene anti toxin (Clostridium novyi), 2 equine
l 100
0.118
Ampoules containing 91 mg of dried hyperimrnune horse serum
Gas-gangrene antitoxin (Clostridium septicum), equine
500
Ampoules containing 59 mg of a dried 1:3 dilution of hyperimmune horse serum in phosphate -buffered saline Bottles containing 10 ml of a solution of dried hyperirrmune horse serum in saline contatning 667. of glycerol (20 IU per ml)
Gas-gangrene .1ntitoxin (Clostridium sordellii), equine
0.1334 (of dry m.a teria] in stock ampoules) 270
v/v
Gas-gangrene antitoxin (Clostridium perfringens alpha antitoxin) ,3 equine
-
Ampoules containing 90.35 mg of dried hyperirmlune horse serum
lst 2nd 3rd 4th 5th
Standard Standard Standard Standard Standard
1931 1935 1943 1953 1963
(0 .3220 (0.2660 (0.3477 (0.1132
mg) mg)
mg) mg)
~
antivenin, equine
300
2.69
Ampoules containing 807 mg of purified, dried, polyvalent (~ and Hemachatus
1st Standard 1964
species) horse serum Scarlet fever streptococcus antitoxin, equine Staphylococcus 0( antitoxin,
10 000
0.049
Ampoules containing 490 mg of dried hyperimmune horse serum Bottles containing 10 ml of a solution of
1st Standard 1952
220
-
equine
dried hyperimmune horae serum in phos • phate-buffered saline containing 0.01% w/v of thiomersal (20 IU per ml) 49
1st Standard 1934 (0.5000 mg) Znd Standard 1938 (0.237b mg) 3rd Standard 1982
Syphilitic serum, human Tetanus antitoxin, equine4
-
Ampoules containing 177.4 mg of dried human serum Ampoules containing 47 mg of free2e-dried hyperimmune horse serUm (1400' ru per ampoule)
1st Standard 1958
l
400
(1000 Lfequivalents for floccu1ation) ANTIBODIES (held in Weybridge)
1st Standard 1928 (0.3094 mg) 2nd Standard !969
Anti-Brucella abortus bovine
serum~
1 000 (aggl.) 1 000 (CF)
Ampoules containing 95.52 mg of freezedried bovine serum (1000 IU of agglutinating activity and lOoo IU complementfixing activity per· ampoule) Ampoules containing 89.7 mg of freezedried hyperiUIDUne horse serum Ampoules containing 79.6 mg of freezedried hyperiDIDllne horse serum
lst Standard 1952 (0.091 mg) 2nd Standard 1%7
Anti-canine distemper serum
1 000
1st Standard 1967
Anti-canine-hepatitis serum
1 000
lst Standard 1967
1
The history of the standard is not entirely clear.
there is no information on the 'Way in -which i t was defined.
Apparently (Bull. Health Organ. L.o.N., 1935) a standard existed since 1922 but The pTtaent ·standard wa& prepared in Copenhagen in 1934 and is the first
with a clearly defined unitage. 2 Valid equivalent for the synonym Clostridium oedematiens, which the International Committee on Systematic Bacteriology has now declared invalid (Int. J. System. Bacteciol. 1
1980, 12_, 225).
3 4
Valid equivalent for (perfringena) (Ciostridium welchii type A antitoxin) ... see pt'evious footnote. The~
This serum is also suitable for flocculation. assumed that the ampoule contains 1000 Lf-equivalE!nts.
to in vitro ratio is 1.4;
therefore for pract·ical purposetf it may be
III!AJ/,2/ pag£' :J
LIST I. (held in Weybridge) (continued)
BIOLOGICAL STANDARDS (continued)
~
xu Preparation per ampoule l 000
mg/IU (if rel.evant)
Form in which available
Years of eltabUshmt-nt (in brackctl, welgl>t o! pre vi standat'd c:ontainil\8 one Ill
Ant i-Salmonella EulloruJfl erum (Standard Form S)
-
-·---Ampoules containing 83.8 mg of freezedt'ied go_at aerum- prepared against a standard English field strain (strain 11) lat Standard 1973
Ant i-Salmonella E:ullorum erum (Variant Form V)
l 000
Ampoules containing 81 .4 mg of fre:eze. dri,ed goat serum prapared against an American variant strain Ampoules containing 889,5 mg of freezedried pig serum Ampoules. containing 68.5 mg of dried hyperimmune horse serum Ampoules containing 65.7 mg of dried hyperimmune horse serum
lst Standard 1973
Ant i-swine-fever serum
1 000
-
tst Standard 1963
Clo stridium E:erfrinB;ens b etal antitoxin
5 000
lst Standard 1954
Clo stridium perfringens psilonl antitoxin Swi ne erysipelas serum (a · nti-N) ~~
1 000
lst Standard
1~54
628
Ampoules containing 87.9 mg of dried hyperinunune horse serum
I
1st Standard 1954
(held in Copenhagen) 132 Ampoules Containing 75 mg of diphth~ria toxoid adsorbed on aluminium hydroxide (1.0 mg Al/ampoule) plus polygelinc (20 mg per ampoule)
Diphtheria toxoid, adsorbed
1st Standard 1955 (0. 75) 2nd Standard 1978
Diphtheria toxoid, plain
200
Ampoules containing 21 mg of formalin~ treated diphtheria toxoid, frt=eze-dried Ampoules containing O.OOS mg of purified diphtheria toxin plus 1 mg of bovine albumin and 2.74 mg of phosphate buffer salts Ampoules containing 25 mg of freezedried vaccine
!st Standard 1951 (0.50 mg) 2nd Standa-rd 1975
Diphtheria (Schick) test toxin
900
1st Standard 1954
Pertussis vaccine
ht Stor'ldard 1957 2nd Standard 1980 1st Standard 1965 2nd Standard 1981
Tetanus toxoid, adsorbed
140
Ampoules containing 27.5 mg Of a dried mixture of tetanus toxoid (90 Lf/ ampo'lle) adsorbed to aluminium hydroxide (1 mgAt3+/ampoule) and 22.5 mg of haemacel
Tetanus toxoid, plain
833
0.03
Ampoules containing 25 mg of alcoholputified tetanus toxoid plain plus glycine
1st Standard 1951
Tuberculin, old
Ampoules containing 2 ml of Old tuberculin (90 000 IU per ml)
lst St-andard 1931 (0 .0100 2nd Standard 19)5 (0,0100 3rd Standard 1965 lst Standard 1954
~~) ~I)
Tuberculin, purified protein derivative (PPD), avian Tuberculin, purified protein derivative (PPD) ,. ma.omalian ANTIGENS (held in Weybridge)
500 000
0.0000726
Ampoules containing 10 mg of PPD plus 26.3 mg of salts Ampoules containing 10 mg of PPD prepared frotn a human strain plus 4 mg of salts
500 000
0,000028
lst Standard 1951
Newcastle diseaae vaccine (inactivated)
525
Ampoules containing 525 mg of freezedried vaccine derived from formaldehydetreated allantoic fluid of eggs inf~cted with strains of Newcastle disease v1rus, adsorbed on aluminium hydroxide Ampoules containing 499 mg of dried vaccine derived from formaldehydetreated Erysipelothrix rhusiopathiae type B, adsorbed on aluminium hyQroxide
lst Standard 196:.\
Swint erysipelas vaccine
1 000
I
1st Standard
~ 959
BLOOD PRODUCTS AND RELATED SUBSTANCES (held in London)
Blood coagulation f(lctor VIII, C, concentrate, human
J. 9
Ampoules containing 15 mg of a freu:edried ccmcentrate of hUman blood coagulation factor VIII Ampoules containing 5.92 mg of a freezedried concentrate of human blood coagulation factor IX Ampoules containing ap_proxims.tely 8. 8 mg Of ·&Odium hepatin from poi'cin~ intestinal mucosa, freeze-dried
lst Standard 1970 2nd Standard 1976 1.1 Ill/amp(•ul{> 3rd Standard l Q82 1st Standard l976
Blood ~.:oagulation factor IX, human
5.62
Heparin, porcine
I 370
1st Standard 1942 (0 .0077 mg) 2nd Standard 1958 (0 .007 7 mg) 3-rd Standard 197 3
1
Valid
Bacteriolo~y
equival~mts for synonym Cl. welchii (perfringens) types B and D antitoxins, which the International Connittee on Systematic:. has now declared invalid ·(Int. J. Syst;em. Bacterial .• 1980, 12.,. 2-25).
IIllA) 7. 27
pa3e 6 LIST l. BlOLOGlc.t.L : SV.!IDAilDS (continu ed )
BLOOD PRO!lVCTS AliD RELATED S!Jl!STANCES (he ld in London) (continued) lU
PreParation Streptokinase and strepto-
ms/ru ( if relevant ) Form in which · available
per Ampoule
Yeare- of estabiilhwmt (1n brac:tcet·s, weight of previoue atand&_~d · Co~tainin& one
tu1
dornase Streptokinase Streptodor n a se
3 100 2 400 100
Thrombin. - human
-
Amp·o ules c:ontrlning approxima t ely 1 mg of extract 'with 5 mg of lactose,
lat Stanc!aril 1964
free z e ..dried
Ampoules c:ontai.ning a pproximately 3.5 mg Of partially· purified fre eze-dried h uman thrombin and 5 mg sucrose
1st Stan<lard 197 5
BLOOD PRODUCTS AND RELATED SUBSTANCES (held i n Copenhage n )
I
Alphafetopro t cin, human
1100 000
Ampoules containing 139.91 mg o f freezedried cord serum
I
h t Standerd 197 5
BLOOD PRODUCTS AND RELATED SUBSTANCES (held in Amsterdam) Anti-Rho (anti-D) incomplete blood-typing serum , human 32
Ampoules containing a pprox imate ly 30 mg of dried material derived fr om 0 .5 ml of poo led human 6erum Ampoule s containing 5 . 94 mg of s heep ant i-human Ig, freez e -d ried Ampoules containing 4.47 mg of ft'eezedried sheep anti-human I gH Ampoules containing 9.23 mg o f f r eezedried s heep ..&nti-hwitan IgG, an ti-Y chain Ampoule s containing approx imate ly 99.9 mg of dried ma ter ia l de rived from 1 ml of human serum Ampoule~
~~1966
F I TC - conjugate d sheep anti -human lg FITC-conjugated sheep
100
1st Standard 1976
100
1st Standa rd 1977
anti -human lgM flTC-conjuga t ed BhE'!ep anti-hum.."''.n IgG (anti-'( chat.n) Anti -A b l o od -ty p ing se r um, human
100
lo t Standard 1981
470
lo t Standard 1950 2nd St andard 1981
Ant i-B blood-typing serum,
860
human
containing approximately 83.0 mg of 'd:.:.i ed mater ia l derived from 1 ml of human serum
1st Standard. 1950 2nd Standard 1980 3rd Standard 1981
Anci-A ,B blood-typing
400
serum, human
e.n t i-A 240 a n ti - B
Ampoules containing approximately 93.3 mg o f d ried mater ial derived f r om 1 ml o f human s erum
~~
1981
Ant i -C incomplete, bloodt y p ing s e ru:m, human
64
Ampoul e s containing 3 9 .0 mg o f f reeze dried human anti- C blo od-typi ng se rum diluted in AB. s erum
~ndard
1976
ENDOCRINOLOGICAL AND RELATED SUBSTANCES (he ld in London)
Arginine vasopressin, bioa!lsay
for
8.2
Ampou les containing a pproxima te ly 20
p8
lst Standard 1978
o f f ree ze-dried aynthetic arginine vaso presain pept ide aceta te with 5 mg human a lbumin and c i tric a cid 5 300
Ch • :>r ionic gona d ot rophi.n, huma n , fo r bioassa y
Ampoules conta ining a pproxi mately 2 mg of f r e eze-dried e xtract o f chorionic gonadotrophin from human u r i ne of pregna ncy, with 5 mg lac t ose
lo t Stand a rd 1939 (0.1 llll!l 2nd Standard 1963
Corticotrophin
(~CTH ) ,
5 .0
por cine, fo r bioassay
Amppules . containing approximately 50 pg of freeze -dried Cort i c o t roph in f rom the anterior l ob e s o f p roc ine p i t u itary gla nds, with 5 mg lac t ose Ampoule s containing a pproxima t e l y 2 7 pg of 1- (3-me rca.ptoproprionic a c id) - 8-D• argin~nevasopressin , l with 5 mg of human albumin a.nd c itric ac id
1st Standar d 1950 ( 1.00 llg ) 2nd St andard 1955 (0. 88 liS) 3 r d Standard 1962
De smopr e ssin
27
1s t Standar d 1980
Glucago n, b ioassay
po rcin e ~
f or
1. 4 9
Ampoule s containing a pp r oximate ly 1 . 5 mg of f r e ez e -dried porcine glucagon. with 5 mg lactose and sodium chloride 1.0 Amp~u l es
l s t Standard 1973
Gr owth h o rmone, bovine, f o r bioa ssay
c ontaining a pproxi mate ly 30 mg of dried growth hormone f rom b ovine pitu ita ry
1st Sta ndard 1955
Growt h ho rmone , human , fo r bioas s a y
4.4
Ampoule s c ont ain i ng 1 . 75 mg of freeze dried purif ied human growt h hormone (2 8 . 1 mg of t o t a l solid ma ter ia l) 0 . 04167 Amp~les
lot Standard 1982
I nsul i n , b ovi ne and por cine, for b i oa ssay
containi ng approximately 110 xng of ins ulin ; cocrystal l i z:e<i f rom a mixture of 52% bovine an d 4 8% poi-cine inoulin ( 24 , 0 . lU per mg )
1st 2nd 3rd 4th
Standard 1925 (0 .12500 ~>g) Sta nda rd 1 935 (0 .04550 IDS ) Standard 1952 (0 .Olo082 ms ) Standard 1 958
Ki nino ge nas e • po r c ine , panc r ea tic
22.5
Ampoules c ontaini n g appr oxima t ely 20 }J8 of f reeze-dried po rcine panc r~atic kininogenase with 5 ·mg human albumin Ampoules containing approximately 23 . 4 p& o f f ree te-dried 11y nth e tic lysine vaso pre s s i n , wit h 5 mg a l bumin and c it ri c ac id
lo t Standard 1982
Ly s ine vasopress in
7. 7
!.!!.~ 1978
1
F o nnerly known as 1-deamino-8 - D-argini neva sopr essin .
WHA3 7,27 pag• 7 LIST 1. BIOLOGICM. STAiillt.RDS · (continued)
BIIDOCIUNOLOGICAL Alii) IILATED SUIIS'I:AIICIS (held in Lonq) (continued)
IU PreParation Oxytocin, for blo&'IHY
raa/tu (1f releVIIt\t) PorD1 in which available
par &JIIIIOule 12.5
Year.• of eetabliahntent (1n brackau, V.ipt of prevlouo etandard containing llne I U)
0.04545
Ampoulea contalnins approxt.ately 21.4 1'8 of dried aynthet1c oxytocin peptide with 5 118 human albumin and citric acid Ampoule• containing approximately 10 lA& of freeKe-dried purifi.ed prolactin fr0111 sheep pituitary glands (22 .0 IU/aog)
4th sundard 19781
Prolactin, ovine, for
bioassay
1 600
lst Standard 1939 (0.1 108) 2nd StanAI&rd 1962
Serum gonadocrophin, equine, for bioaaiay
13.5
Ampoules containing approximately 0 . 8 mg of freeze.dried extract from the serum of pregnant mares, with 5 mg lactose
let Standard 1939 (0. 25 •g ) 2nd Standard 1966
Thyrotrophin (pituitary TSH), bovine, for bioassay
-
Aapoulee CMtaining 10 tablete of approxt .. mately 20 .g of a blend of 1 part of purified thyrotrophin frOID bovine pituitary glanda and 19 parts o! lactoee Alr.poules containing approximately l mg of freeze-dried extract of urine from post ..menopauaal women , with 5 mg of lactose
lat Standud 1954
Ur~nary
fSH and
1st Standard 1974
111 (ICSI!) , human
for btoaseay FSII activity 111(1CSH) activity
54.0 (FSH)
46.0 (111)
76.0
HlSCE!.LAIIEOUS (held in London) Digitalis Ampoules containing approximately 2500 mg o f dry poWered leaves of Dtaitalis purpurea (0.01316 lU per ft\8)
lot Standard 1926 (100 .0 mg) 2nd Stundard 1936 ( ll).O IIIII ) 3rd Standard 1949 l&t Standard 1955
Hyaluronidase, bovine
Approx. 200 IU per tablet
Ampoules containing 10 tablets of approximately 20 mg of dried b ovine testicular hyaluronidase diluted wi th lactose (10 IU/mg )
Vitamin D
1.0
Bottles containing appro!imately 6 g of a solution of vitamin D) in vegetable oi l ( 1000 lU per g )
lot Standard 1931 (0. 1 m .. ) [f.rradiated eri(' lteroy 2nd Standard 1949
1 '11\e first Atandard for oxytocin and vasopreeain~ for bioassay. was established in 1925. the second in 1942 and the third !.n 1957. This combined standard was discont inued in 1978, when a separate standa rd for oxytocin, f or bioassay, was eatabl1ahed. Since the unltaae of this standard was baaed on the oxytocin uni~age of the combined standard, it wae called the 4th Standard. 2 The lnternation•l Nonproprietary Naae of vitae.tn DJ is coleealciferol,
WHA37.27 p•g• 8
LIST II.. ANTIBIOTICS (held in London) IU mg/TU (if
BIOLOGICAL REFERENCE PREPARATIONS
Preparation
per ampoule 8 910
Form in which available
relevant) Ampoules containing 5 mg of bhomycin
Years of estab Ushment (in brackets, weight of previoua standard containin& one IU)
1st Reference Preparat ton !980
complex Candid.din 0.0004766
Ampoules containing approximately 50 mg of candicidin (2098 IU per mg) Ampoules containing approximately 80 mg of capreomycin sulfate (920 IU per mg) Ampoules containing approximately 50 mg of sodium cefalotin (938 IU per mg) Ampoules containing approximatt ly So mg of clindamycin hydrochloride (837 Ill per mg) Ampoules containing approximately 75 mg of c0listin methane sulfonate (12 700 lU per mg) Ampoule:. containing approximately 80 mg of demethylchlortetracycline hydrochloride (1000 IU per mg)
lst Reference Preparation 1978
Capreomyc in
0.001087
1st Re ferenct Preparation 1967
C8falotin
0.0010661
lst Reference Preparation 19&5
Clindamycin
0.0011947
1st Reference Preparation 1971
Col i::;tin methane sulfrmdte1
() .00007874
lst Reference Preparati.on 1966
n._·methylch l.ol"tetracyc l ine 2
() .001
1st Reference Preparation 1962
Ooxycyc line
0.0011494
Ampoules containing approximately 75 mg of doxycycline hydrochloride hemiethanolate hemihydrate (870 IU per mg) Ampoules containing approximately 50 mg of gentamycin sulfate (641 mg IU per mg) Ampoule~
1st Reference Preparation 19 71
Gent amy{.: in]
0.00156
lsl Reference Pre par at ion l968
Gramicidin
0.001
containing approximately 55 mg of gramicidin (lOOU 1 U per mg)
1st Reference Preparation 1966
Kanamycin
0.001232
Ampoules containing approximately SO mg of kanamycin sulfate (812 IU per mg) Ampoules containing approximately SO mg of lincomycin hydrochloride (881 Ill per mg) Ampoules containing approximately lOU mg of lymecyc line (948 I U per mg)
1st Reference Prepara:t ion 1919
Lincomycin
0.0011351
lst Reference Preparation 196'>
Lyme eye 1 ine:
(J
.Oc;1J548
1st Reference Preparation 1968 (0 .0010548 mg) 2nd Reference Preearat ion 1971 1st Referen~:e
Methacycllnc4
0.001082
Ampoules containing approximately 50 mg of methacycline hydrochloride (924 JU per mg) Ampoules containing approximately 75 mg of minocycltne hydrochloride (863 Ill per mg) Ampoules containing approximately 50 mg
Prf;!parat ion 191)9
l-!inocyc I i ne
0.0011587
lst Reference Pre_£,!rat ion 19 IS
:-Jeomycin
0.0012903
of neomycin sulfate (775 IU per mg)
1st R~ fE!rence Prepar<~l ion 19)8 (0.00147 mg) 2nd Reference Pre ear at ion 1974
Nemnycin RS
16 756
0.001492
Ampoules containing approximately 2 5 mg of neomycin B sulfate (670 IU per mg) Ampoules containing approximately 7r) mg of paromomycin sulfate (750 IU per mg)
1st Reference Pre para!: ion 1970
0 .UOl1J'.'
ist KeferE-nce Preparation l'J61
Procaine benzylpeni.ci \lin in oil with aluminium monoste<i.rate
Bottles containing approximately 10 ml of procaine: benzylpenicillin in oil with aluminium monostearate, for injection
lst Reference Prepar<J t ion 1962 2nd Reference Prepa1·ation \{)fJ'j
H.i famycin svb
0.001127
Ampoules ccmta ining approximately 100 mg of sodium rifamycin SV (887 Ill per mg) Ampoules containing approximately 71 mg of spectinomycin dihydrochloride pentahydrate (671 TU per mg) Ampoules containing approximately 50 mg of spiramycin base (3200 IU per mg)
lst Reference Pre par at ion l9b7
Spectinomycin
0.00149
lst Reference Pre par at ion 1975
Spi r;unycin
0.0003125
lst Reference Preparet ion 1962
------1 In some countries this antibiotic is known as "colistin su1phomethate" or "colistimethate".
The lnternalional Nonproprietary Name of this substance has been changed to demeclocycline. The International Nonproprietary Name of this substance has been changed to gentamicin. 4
Th• Internationcll Nonpropriet<uy Name of this substance is metacyc line.
5
Tht International Nonproprietary Name of this substance is framycetin. The J ntcrnational Nonproprietary Name of this substance is rifamycin.
6
LIST Jl. l!!!llBlOTlCS (held in London) (cantinued)
BlOLOOlCAL J~FEIU:NCE PREPARATIONS (continued)
Pr.eparatioa
lU por ampoule
.,.jru (if re~ev&~~t)
Form in which available
Year• ol ••tabliahMnt (in bracket•, veiaht of previo standard containina one It:) lat Re ferenc c Preellrat ton 1980
Tobr .1mycin
-
0.0010142
Ampoules containing approximately 80 ma of tobra'tllyct.n baa• (98~ IU per "''Il Ampoule• containina approximately 100 fD1 of triacetyloleandomycin (8)3 IU per Jll) Ampoules containing approximately 100 of viomycin a·u lfate (814 IU per mg) t'llg
Trtacet y lo leandorayc in L
0.0012
lot Reference Pre2arat ion 1962
ViomycJ.n
0.0012285
lat Reference Preparation !9S9
(0.00137 "''Il 2nd Reference Preearatton 1969
ANTIBIOTICS (held in Weybridge)
I Niein AN'I'lBODIES (held in Copenhagen)
I ~erum
0.001
Ampoules containing 85 mg of nisin
(1000 JU per "''Il
I
let !Wferenc• Prep& rat ion 1969
Ant1 .. measles
1 human
10
Ampoule a containing 93.8 mg of dried huiJian serum Ampoules containing 145.95 mg of freeze-
lst Reference Pre par at ton 1964 1st Re ferenee Pr.,parAtlon 1~662 Znd Reference. P£eparat1on 1970 lot R~ference
Anti-rubella serum, human
dried human immunoglobulin Ant i - staphylococcal P-V t eucoc t.din serum, equine Anti-typhoid serum, equine !SO Ampoules containing 53.5 mg of freezedried horae serum
Pre per at ton 1965
Ampoul4!s containing 5 ml of dried hyperianune horse serum 14)
1st Reference Preparac ton 1952
Anti -y~ llow- f ever serum, monkey Diphtheria antitoxin, e qu ineJ fer f loc:culation test
o.s
Ampoules cont~ining approximately 71.5 mg of dried aonkey •erucn Ampoules contain-ing 120.17 rng of freeze· dried purified hyperiurmune horse 1erum
1st Reference Pre par at ton 1962
l 800 Lf· equi-
vn tents
ht Reference Preparation Znd Reference Preparat ton Jrd Reference Preparation 4th Reference Pr•paral1on Sth Referenea Pre~aratlon
1935 1938 194S 1956 1971
Rhcum<~toid
arthritis
s ~rum,
100
human ANTlBOOlES (held in Weybridge)
Ampoule a containing 17 , l mg of freezedried pooled human eerum
let Reference PrepAration 1970
Ant i-Mycoplasma sall.i&epticum se1·um Ant 1-Newcasc le-diseaae serUU~
I 000
Ampoules containing 55.6 mg of freeze .. dried chicken aerum Ampoule• containing 55.5 1'18 of freeze ... dried chicken eerum
1st Re ferenee Preparat i"'n 1969
320
let Reference
Pre~:aration
1966
ANTIBOUI< S (held in London )
I
Ant i-thyroglobu 1in serum, hum3n
Ampoules containing approximately 44.3 mg of freeze-dried human autoin~nune aerum
!1st
Refereace Prepautlon 1978
ANTIGE NS ( held in Copenhagen)
I I
Rabies vaccine
1()
Ampoules contain ina approximatel y 49.45 mg of freeze-dried rabies va.cc ine prepared in human diploid cells and inactivated with propiolactone
2nd Reference Preparat lon 196~3
lsc Referenc~ Preparation 19603
Jrd Reference Pre par at Lon l 978
ANTI GENS {he ld in Weybridge) Anthr a x spore vaccine
l.O
Ampoules containing a freez:e-dried ttptlt"~ suepension of Bacillu• anthracis strain 34 F2 (approximately 108 culturable spore• per ampoule)
1st Reference Prepa rat ion l978
BLOOD PRODUCTS AND IU:LATED SUBSTANCES (held in Copenhagen)
I
Prl.!gnanc y-specific glycoprotein
pt
o .075
I
Ampoules containing 45.16 m.g of freezedried purified serum from pregnant (~omen
1st Reference Preparation 1952
BLOUU PRODUCTS AND RELATED SUBSTANCES (he 1d in London)
An ct·od
55
Ampoules containing 16.90 mg of purified ancrod in lactoae and human serum albumin Ampoules containing 14 .76 InS of human itiiiUooglobultn (60 Jll of anti-D iaamog lobu lin)
lat Reference
f.t.~~!li?...!!.
1916
Anti-[) immunoglobulin, human
300
lat
Ref~trence
Preparat1Qn 19/6
1
Th e lnternational Nonproprietary Natne of thia aub4tanee has been changed to troleandomycin.
2
No units were assigned to this preparatiou . 3 No units were assigned co theae preparatione.
WIIA31,27 page 10
LIST II.
BIOLOGICAL REFERENCE PREPARATlONS (continuad)
BLOOD PRODUCTS AND !!ELAUD SUBStANCES (held in. London). (continued) lU
mg/Iu (if
Preparation
per ampoule 0.9
Farm in which available
relevant) Ampoules containing the freeze-dried residue of l ml human plasma Ampoules containing 2. 36 mg of freezedried carcinocmbryonic antigen Ampoules containing the freeze-dried residuE:' of l ml human plasma
YeRrs of Pstablishment (in brackets, weight of previouf; standard containing one II')
-1 i !
Ant ithrornbin 111, plasma
1st Reference Preparation 197A
Carcinoembryonic antigen (CEA) , human ~'actor Vlll-n:l.::~.t~d
100
1st Reference Preparation 1975
activitt.es in plasma
0. 71 VII 1 ;C 0.87 VIII; RAg
ht Reference Prcp<tratior. L982
0.80 VIII R; RCof 0.95 VIII C:Ag Human ::oertun immunoglot;ulin E ( lgE)
5 000
Ampoules containing approximately 7':> mg of the free2~-dried r~sidue from citrated human ptasmn Ampoules cnntatning appr,ncimately 81 mg of the freeze-dried residue from diluted pooled human Serum (100 IU IgG, 100 I U IgA, and 100 Ill IgM per ampoule) AJnpoules containing approximate ty 1 .0 ml of a solution of partially purified plasmi.n in 50"/ glycerol
1st Reference Preporati.on i971 2nd Refer4!nce PreparatiOf!. 1980
Human serum immunc-
100
lst Reference Preparation 1970
globul ins G. A, and M (IgG, IgA, and [g/1)
(of each)
Plasmin, human
10
lsr R1•fPrence Preparation 1':176 (8 .u Ill) ~nd Rr>fct(!OCt:: Preparation 1982
Thromboplastin. bovi.nc, combined
Ampoules containing freeze..:dried bovine thromboplastin ~.;o:ith bovine plasma, adsorbed with BaS04, CaCl2 and cephalin. International sensitivity Index == 1 .0 Ampoule~
Thromboplastin, human combine<i
cont.tining a
frr>eze~dried
1st
Ref~reocl:'
Prep;~r.Jtion
1976
susp•'r>~ion nf human brain mixed with bovine (actor V • bovine fibrinogen and calcium chloride. lntPrnational sensitivity lnrlex "" 1.0
ThrombopL.l:;tin, rabbit,
plain
Ampt,uJ,:s t'•.\nt lining freeze-dried rabbit brain suspen!'lion. International sensitivity Index = 1.4 Ampoules contolning <tpproxim:ttely 1.4 mg of partially purified freeze~dricd urokinase from human urine, with 5 mg lactose
1st
Rt.lfcrenc~
Pteparat ion 1978
lst Rl'ferencn Preparation l91>A
~~~
AND RELATl'.:D SUBSTANCES (held in Amsterdam)
Anti-nucl~:•r-factur
se.rum (h(:>mogeneous), 1 human
100
() .186
Ampoules containing approxtrnately 19 mg of the frecz6:'~dri.ed rP.sidue of 0.2 ml of pooled human _gerum (18. 6 mg ~ ') .t!"i') Ampoules contniuing .ant i~hepatitis A immunoglobulin ( fracl ionated plasm.:~, ~terence
Hepatitis A inmnlnOglobulin
100
Pn:par&ti9..!! 198!
freeze-dried) Hepatitis P, :immunoglobulin
50
Ampoules contAining anti-hepatitis B immunoglobulin (fractionated plasma, freeze-dr:i.ed) Ampoules contnining. llO. 7 mg of freeze~ dried residue of l ,) ml of human serum
lst l<t·ference
Pr~paration.
1977
Human serum complement c::.:-mp-::mcnt:o t.lq, C4, CS,
100 (of v .1 ch)
1st RcferPnce Pr•:paration 1980
(actut· B and wht)le functional compl~~ment CHSO Human serum proteins, for immunoassay: albumin; alpha-l-antitrypsin; alpha-~) -macroglobulin; cerulnp lasmin; complement CJ; t r..1nsferri n 100 (of each) Ampoule3 containing Ill .4 mg of dried material derived from 1.3 ml of huinan serum
1st Reference Preparation. 1977
ENDOCRINOLOGICAL AND RELATED SUBSTANCES (held in London) Calcitonin, human, for bioassay 1.0 Ampoules containing approximately 8. 5 J.lg of freeze-dried synthetic human calcitonin peptide with 10 mg mannitol Ampoules containing approximately 10 ,ug of freeze-dried purified porcine calcitonin, with 5 mg mannitol Cal.::itonin, s.'llmun, for
ls[ Re ferenct' Preparation 19 78
CB.icitonl
l),
porcine, tor
l.O
1st
R<~ferencL'
Preparation J!J 't,
bio.<.s~uy
8u
bioassay
Ampoules containing approximately 20 JJS of freeze-dried purified synthetic salmon calci.tonin, with 2 mg mannitol
lat Reference Pcepuration 197''
1 ~--'r
Serum
Fn~m thl~
Biologj~,~;
same batch ,,f material i1S this international rt!ferenr~e prepard.tion is available from the Di.reeror, National Jn.'olt:irntP S:cwdards and C0otroJ, Hampstead, LL1ndon NW3 6RB, England.
\o/HI\ .H , 27 page 11 LIST li. BIOLOGICAL REFERENCE PREPARATIONS (continued)
oNOOGRlNOI.OGlCAL AND RELATED SUBSTANCE S (held in London) (co ntinued )
ru Prepar~ti o n
m11/IU (if relev«nt)
por ampoule
fonn in which
av~il8 ble
Years l)f estnblishnwn t (:in brackt'tfl, weight of pn·vJ< ·u ~. standl\rd cont" f niriR emf.• Jl!)
l -~
f---- - - · - - - - - + - - , - - - + - - - - 1 - - - - - - - - - - - - l - - - - - · - · - - - - - - Clw rloui1:. gtHwd•) tt'1Jphi.n, human, for
l"'unoasoay
6~0
Ampnulea cont~:~.ining approximately 70 J~$
~~.,!~:~~:-::~::o~~~~~rn~u:~:~·~ ~~man human albumin
ie:t Rehrf'ncc PreparatiMI 197S -
I 1
Chl)rioni.c gunado troph i n , alpha ~; ubunit, huma n, for ~_mmunnA.s!'lay
70
Ampoules CCint.:lining approximatel.y 70 }I& of freeze·dried highly purified chorionic gonado trophin, alpha subunit, with 5 mg human albumin Ampoulcf> co nt aining approximately 70 p& of freeze-dried highly purified chorionic gonrt.dotrophin. be ta subUnit, wit h 5 mg human nlbumin Ampoules cont.Jining approx imately 2 mg of fn.· ~2~-drh,d ~xtract tl f human urine>, with "j mg sodium c hlorid l.! Ampoules con t..1in i ng :lpproximately l .) mg of fl'"e~ze-dried porci n e glucagon, with 5 mg lactose and sodium chl ori de
1st Reference Prep.nati.on 11/ i'S
I j
Chor i o ni c go nadotrophin, hPta subunit, human, for imtnllO!) :It"iSay
70
1st Ref ere nce Pr e paration t97S
I
I lst Re!t:rence- Pr~:p<aat ion 1 9brl ( !.45 m~l 2 nd Hefert>n~(· rn'2llr..ttion lq/p lst Refcr~nce
Er ythr u ~Oil.'t
in, human,
10.0
I
urin :ory, for bio <1 ssay
Glu cago n,
p0 rcin~,
(o r
1. 49
Prep.1.r.ation i974
.itnffiUO Jli iSS.'ly
G ( lO<ld (Hl· l
rcit•:-Jsin~
i u (g,n n ;_ ld n t hc1rmnnP-)
ro pl~in~
31
t-nr
bio:t.<; !> :ty
Ampoules conto1ining the freeze-drieU residue of ·~ solution co ntain1ng appr ox imately 5P ~~g of go nador t:' lin acet ~lte, 2. 5 mg ! actos e, 0. ) mg hurt1an plo1Sma .1lbumin Ampou l es containing appr oxima t~ly l7S pg. of freeze-dried purified human gr•)wt h hormone. , with 5 mg !:HJcrost~ ;tnd huift.>r sa lt s Ampoul es containing app roxima tt·ly l)u pg of fr~eze-dried cry~talli ze-d human insu 1 in, with S mg ~ucros<> Ampoul es containing appn)Xi mately 0.6 mg of freeze-dri~d trichl oro acetic acid extract of bovine parathyroids, with ) m)~ l acl:o.·."
LH Reft.· renc~ l'rt=-earat ivn 1980
Growth JLc,nnone 1 hum,:m (llGH), for innnuno:t~;H ay
0.)50
lst Rt•ft!re nell' Propllt;ttion 1968
1T1'11J lin , \HJru,> n f cJ r tmrnun•l .'lS<>ay
3.0
1st: Kefl·rt!nc;:e rn.:p<lr:atl:~'l 1974
Pa ratby n~id
hormone , bovine for bio :1ssay
1
1st Reference !'reparation 1974
Pa r:tthy r·nicl \]l)rmnne • human , I c ~r i.mmunoassay
0.1
Ampoul~s
app n1xirna tely ~,o ng purifit!d hormone, with 250 pg human serum ;Jibumin, and 1 .2') mg fn.•cze~dried l.1 ctt\~i'
ct>nt:1inin)~
1st Re fen:n cl• Preparation \981
PHrathyr(lid hormo n e for immunoassay
1
bc)vinc,
2 .0
Ampoul es cont~lining .:.lppr oximatel y 1 jJg of freeze-dried purifif!d isohotmone 1 from bovine parathyroids, with 200 jJ g hum.."ln albumin and 1 mg lactose Ampoules co nt ain~ng appr o ximately )C>O J-11>, of freeze-dried e xtr ac t of human pituit3rie~, with 1.25 mg lact o~c
l~t
Re(cr-:·nce Preparat iPn 1974
Pituitary FSH and LH (1 CSU) , human , (or bif>assa.y F'SH activi ty
lst Ne h• rc.nce l' rt-p or~l t ir>n 111 11. Znd Rt.>fen·nce f' r OJ! atllt ion 1980
l.H(H.:SH) ;Jcti v1ty
10.0 (FSH) . 25.0 (LH)
Pitui.t;1ry LH(ICSH) , human, for immunoassay
77
Ampoul es containing appn.))cimately 11.6 pg Qf f ree ze-dried extrac t o f luteinizing hormone from human pitu i taries, with l mg t) { human albumin , S mg lactose, and 1 mg sod iu m chloride Ampoules cont aining approximately 8SO t-'P~ of freeze-dried purified placental lactogen, wit h 5 mg mannitol Ampou l es containing approximatel y 20 pg of freeze-dri.cd highly purified hu,Mn pituitary prolactin, with 1 mg human albumin and ') mg lacto se Ampoule-s ("t>n t a ining approxima t ely 0. 2 7 l'ug of fre~z.e -dr icd purif ied ' ' xtract of r enin from hum.an kidneys, with 5 mg of la ctose and buffer sal t.:s AmpouLes contai n ing approximatel y 490 JJ@. synthetic tetracosactide wi th 20 mg mannitol Ampo ules cc•n taining appro ximately 4(. pg of freeze -dr ied extract l)f thyro id stimulating hormone from human pituitaries, wi.th 1 mg human albltmin and ~ mg l ac tosc
1st Rc fe renee Prcpar at i(ln 19 74
P lacene<tl lact ogen, human, for immuno.1 ssay
0. 000850
1st Refercllce l 1 repnra.tion ll.l ::l
Prolactin, human, fnr Jmmunt13 SSO_ Iy
0 .650
1st -Refe renee
Pr~tpar<~t
i on t9 7B
Re nin, humnn , for bi.oassay
O. l
lst
Rcfttrt>nc~
rn~pat<tt
i o n l '-1 74
T<.·traco s~\c t . idt· ,
fo r bioassay
490
1st -Re (t!rence l'rcparUtl o n I ~S I
fhyr oi d ~l imula ting hermon.-.· (pit.uJl :try TSH), human, for immunoa ss ay
O.I SO
I ~ t ReleT"cnct-
Pr <· E: ·,r~,l..~
1.9 / 1,
WHA31. 27 pAge' \2
LIST 11. MISCELLANEOUS (held in London ) JU per
BIOLOGICAL REFERENCE PREPARATIONS (continued)
mg/Iu (if relevant ) Form in which available
Preparation
ampoule Inte r f e nm, human 1eukocylt· lnto.:r f cron, ch i.:.:i<' 5 (lOU
Years of establishment (in brackets, weight o f pr f'vJ , l u ~.; s tandard cont.llining one .~: ~ _ _ lst Rf' i cr+!Oc l! Prcl:!ar.lt.i o_!l 1'-J 18
~---1
j
Ampoule s of interferon
freez ~ -dri e d
huma n leukocyte
8<)
Ampoules o f
fn:c·z c -dried c h ick int er feron
I
1st
Ref c renc ~
f'reearo.ti v~
19 711
MISCELLANEOUS (held in Nlll, Bc tllcsdu)
Interferon, human
10 uuu
Ampo ules o f freez e -dried h u man fibr o bla s t int~C>rf e ro n
[ iln·nbl.1st
12 0 0(1 j !n l Prft~nm,
Ampoules
l lf
fr etz e -dr i ed mouse int e rfe r on fn~eze-dried
1·abhit
10 0 00
Ampoule s o f interferon
r a bbit _ ___ _
L__ __ ··· - -···-
·--- - - - L - --...1..-- - - - I ._ _ __ _
_ _ __ ___L__ _ _ _ ___