ORGANISATION MONDIALE DE LA SANTÉ
TWENTY-SIXTH WORLD HEALTH ASSEMBLY
16 May 1973
C O M M I T T E E A
DRAFT FIRST REPORT OF COMMITTEE A INDEXED
Committee A held its first, sec|||d, third, fourth and fifth meetings on 8, 14, 15 and 16 May 1973, under the chairmanship of Dr S. Phong Aksara (Thailand).
In conformity with the proposals of the Committee on Nominations,1 Dr R. Pereda (Cuba) was elected Vice-Chairman, and Dr Gurmukh Singh (Malaysia), Rapporteur.
It was decided to recommend to the Twenty-sixth World Health Assembly the adoption of the attached resolutions relating to the following agenda items:
2.3 Smallpox eradication
2.4.1 Quality, safety and efficacy of drugs (2 resolutions) 2.4.2 International standards and units for biological substances
1 Document А2б/37.
SMALLPOX ERADICATION PROGRAMME The Twenty-sixth World Health Assembly,
Having considered the Director-General's report on the smallpox eradication programme,1 Appreciating the decisive contribution made to the global eradication effort by the many countries who have succeeded in eliminating endemic smallpox and recognizing with
gratitude the efforts being made by those where the disease still exists,
Noting with concern, however, that in some areas of the countries where endemic smallpox persists the situation presently appears more serious than in previous years,
Re-affirming, therefore, the necessity to make every possible effort to ensure the speedy progress of eradication and to maintain it where it is achieved,
1. REQUESTS all countries to give the highest priority to the smallpox eradication
programme, with particular emphasis on active surveillance, so as to interrupt transmission of the disease at the earliest possible time in the areas where it is still endemic and to prevent re-occurrence of the disease in countries from which it has been eliminated;
2. REQUESTS the Director-General to continue to give all necessary assistance to the countries concerned in order to support and accelerate national eradication efforts, to determine through independent evaluation whether eradication has actually been achieved, and to identify the additional resources both national and international which may be required for the successful completion of the programme;
3. THANKS the countries that have generously contributed to the programme, either bilaterally or through the WHO Voluntary Fund for Health Promotion, in the confident hope that continued support will be provided to the programme, especially during the critical years ahead.
1 Document A26/7.
QUALITY, SAFETY AND EFFICACY OF DRUGS The Twenty-sixth World Health Assembly,
Recalling resolutions WHA24.56 and WHA25.61;
Having examined the report of the Director-General on the feasibility of an international information system on drugs;1
1. THANKS the Director-General for his report;
2. CONSIDERS that the implementation of an international information system providing data on the scientific basis and on the conditions of registration and withdrawal of
individual drugs would be of considerable importance in the development of a more comprehensive approach to ensuring drug quality, safety and efficacy;
3. BELIEVES that the proposed feasibility study would provide the basis for assessing the potential value of such a system; and
4. REQUESTS the Director-General to develop the proposed feasibility study and to report to a future World Health Assembly on the findings of this study and on their financial implications.
Document A26/8.
QUALITY, SAFETY AND EFFICACY OF DRUGS The Twenty-sixth World Health Assembly,
Recalling resolutions WHA16.36 and WHA23.48; and
Reiterating that all drugs made available to consumers should comply with adequate standards of quality, safety and efficacy and that the World Health Organization has a major role to play in the collection and dissemination of information on drugs,
1. INVITES Member countries to continue to communicate to the World Health Organization any decision by the national control authority resulting in the withdrawal from the market of any pharmaceutical product and to indicate in the communication the name of the product, its composition, its dosage form, the name of the manufacturer and the findings of the studies which resulted in the withdrawal; and
2. REQUESTS the Director-General to continue to disseminate information concerning such decisions without delay and to make this information activity part of the proposed feasibility study on the international information system on drugs.
INTERNATIONAL STANDARDS AND UNITS FOR BIOLOGICAL SUBSTANCES The Twenty-sixth World Health Assembly,
Considering Articles 2(u), 21(d) and (e) and 23 of the Constitution; and
Considering resolutions WHA3.8 and WHA18.7 adopted by the Third World Health Assembly and the Eighteenth World Health Assembly respectively, recommending the adoption of certain international standards and units for biological substances,
I RECOMMENDS
(1) that Member States of the Organization recognize officially the international standards and units enumerated in the list below, which supersedes the lists recommended in resolutions WHA3.8 and WHA18.7:
Quantity equivalent
Old tuberculin (Third Standard) 0.011111 ¿il
Purified protein derivative of mammalian tuberculin 0.000028 mg Purified protein derivative of avian tuberculin 0.0000726 mg
Tetanus toxoid 0.03 mg
Tetanus toxoid, adsorbed 0.6667 mg
Diphtheria toxoid, plain 0.50 mg
Diphtheria toxoid, adsorbed 0.75 mg
Schick test toxin (diphtheria) 0.0042 mg
Pertussis vaccine 1.5 mg
Swine erysipelas vaccine 0.50 mg
Newcastle disease vaccine (inactivated) 1.0 mg
Tetanus antitoxin (Second Standard) 0.03384 mg
Diphtheria antitoxin 0.0628 mg
Anti-dysentery serum (Shiga) 0.05 mg
Gas-gangrene antitoxin (perfringens) (Clostridium welchii type A
antitoxin) (Fifth Standard) 0.3346 mg
Gas-gangrene antitoxin (vibrion septique) (Third Standard) 0.118 mg Gas-gangrene antitoxin (oedematiens ) (Third Standard) 0.0828 mg Gas-gangrene antitoxin (hystoliticus ) (Third Standard) 0.2 mg
Gas-gangrene antitoxin (Sordelli) 0.1334 mg
Staphylococcus oc antitoxin (Second Standard) 0.2376 mg
Scarlet fever streptococcus antitoxin 0.049 mg
Anti-streptolysin О 0.0213 mg
Anti-pneumococcus serum (type 1) 0.0886 mg
Anti-pneumococcus serum (type 2) 0.0894 mg
Anti-Q-fever serum 0.1017 mg
Anti-rabies serum 1-0 mS
Anti-A blood-typing serum 0.3465 mg
Anti-B blood-typing serum 0.3520 mg
Anti-Rh0 (anti-D) incomplete blood-typing serum 0.95 mg
Syphilitic human serum 3.617 mg
Anti-poliovirus serum (type 1) 10.78 mg
Anti-poliovirus serum (type 2) 10.46 mg
Anti-poliovirus serum (type 3) 10.48 mg
International Standards Quantity equivalent to one International Unit - 6 -
Clostridium botulinum Type A antitoxin 0.1360 mg
Clostridium botulinum Type В antitoxin 0.1740 mg
Clostridium botulinum Type С antitoxin 0.0800 mg
Clostridium botulinum Type D antitoxin 0.0121 mg
Clostridium botulinum Type E antitoxin 0.0691 mg
Clostridium botulinum Type F antitoxin 7.44 mg
Naja antivenin 2.69 mg
Anti-smallpox serum 0.08416 mg
Anti-toxoplasma serum 0.090967 mg
Anti-Brucella abortus serum (Second Standard) 0.09552 mg
Clostridium welchii (perfringens) type В antitoxin 0.0137 mg Clostridium welchii (perfringens) type D antitoxin 0.0657 mg
Swine erysipelas serum (anti-N) 0.14 mg
Anti-swine-fever serum 0.89 mg
Anti-canine-distemper serum 0.0897 mg
Anti-canine-hepatitis serum 0.0796 mg
Streptomycin (Second Standard) 0.001282 mg
Dihydrostreptomycin (Second Standard) 0.001219 mg
Bacitracin (Second Standard) 0.01351 mg
Tetracycline (Second Standard) 0.00101833 mg
Chlortetracycline (Second Standard) 0.001 mg
Oxytetracycline (Second Standard) 0.0011364 mg
Erythromycin 0.001053 mg
Polymyxin В (Second Standard) 0.000119 mg
Nystatin 0.000333 mg
Amphotericin В 0.001061 mg
Vancomycin 0.000993 mg
Oleandomycin 0.001176 mg
Novobiocin 0.001031 mg
Colistin 0.00004878 mg
Rolitetracycline 0.001004 mg
Tylosin 0.001 mg
Hygromycin В 0.0008928 mg
Oxytocin and vasopressin (anti-diuretic hormone), bovine, for
bioassay (Third Standard) 0.5 mg
Prolactin, ovine, for bioassay (Second Standard) 0.04545 mg Corticotrophin, porcine, for bioassay (Third Standard) 1.0 mg
Thyrotrophin, bovine, for bioassay 13.5 mg
Growth hormone, bovine, for bioassay 1 .0 mg
Serum gonadotrophin, equine, for bioassay (Second Standard) 0.003569 mg Chorionic gonadotrophin, human, for bioassay (Second Standard) 0.001279 mg Insulin, bovine and porcine, for bioassay (Fourth Standard) 0.04167 mg
Heparin (Second Standard) 0.007 7 mg
Vitamin D (Second Standard) 0.000025 mg
Hyaluronidase 0.1 mg
Streptokinase-streptodornase
Streptokinase 0.002090 mg
Streptodornase 0.002700 mg
Blood coagulation factor VIII 1 1.365 mg
Digitalis (Third Standard) 76 .0 mg
(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 to Member States in the most expeditious and convenient manner, as a contribution towards enabling an acceptable level of quality of biological substances used in medicine to be achieved; and
Recognizing the value 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,
1. AUTHORIZES the Director-General, where necessary for the use of regulatory agencies of Member States, to make additions 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 Biological Standardization or other experts designated to deal with the standardization of particular biological substances;
2. REQUESTS the Director-General to inform Member States periodically when such
international biological preparations are established and their international units have been defined; and
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.
