1965ORIGINAL: ENGLISH AND

W O R L D H E A L T H ORGANIZATION

EIGHTEENTH WORLD HEALTH ASSEMBLY

ORGANISATION MONDIALE DE LA SANTÉ

I

A18/P&B/15 i

11 May

1965

ORIGINAL: ENGLISH AND FRENCH

DRAFT SECOND REPORT- OF THE .‘COMMITTEE ON PROGRAMME AND BUDGET

During the course of its fifth meeting, held on 11 May 1965* the Committee on Programme and Budget decided to recommend to the Eighteenth World Health Assembly the adoption of the following resolution:

International Standards and Units for Biological Substances The Eighteenth World Health Assembly,

Considering Articles 2(u), 21(d) and (e) and 23 of the Constitution;

and

Considering resolution WHA3-8 adopted by the Third World Health Assembly, recommending.the adoption of certain international standards and units for biological substances,

1. RECOMMENDS

(a) that Member States of the Organization recognize officially the international standards and units enumerated in the list below, which supersedes the list recommended in resolution WHA

3

8

International Standards Old tuberculin (Second Standard)

Purified protein derivative of avian tuberculin Tetanus toxoid, plain

Diphtheria toxoid, plain Diphtheria toxoid, adsorbed Schick test toxin (diphtheria) Pertussis vaccine

Swine erysipelas vaccine

Newcastle disease vaccine (inactivated) Tetanus antitoxin

Diphtheria antitoxin

Antidysentery serum (Shiga)

International Units

0.0100

O.OOOO

726

0.03 O.

5

0.75 0.0042 1.5 O.

5

1.0 О

.3094

O.O

628

O.O

5

A18/P&B/15

page 2

International Standards International Units Gas-gangrene antitoxin (perfringens) (Clostridium

welchii Type A antitoxin) (Fifth Standard) 0.3346 mg Gas-gangrene antitoxin (vibrion septique) (Third

Standard) 0.118 "

Gas-gangrene antitoxin (oedematiens) (Second

Standard) 0.1135 "

Gas-gangrene antitoxin (histolyticus) (Second

Standard) 0.2 "

Gas-gangrene antitoxin (Sordelli) 0.1334 "

Staphylococcus <ч antitoxin (Second Standard) 0.2376 Scarlet fever streptococcus antitoxin 0.049 "

Antipneumococcus serum (Type l) 0.0886 "

Antipneumococcus serum (Type 2) 0.0894 "

Anti-streptolysin 0 0.0213 "

Anti-Q-fever serum 0.1017 "

Antirabies serum 1.0 "

Anti-A blood-typing serum 0.3465 "

Anti-B blood-typing serum 0.3520 "

Syphilitic human serum 3-617 "

Antipoliovirus serum (Type l) 10.78 "

Antipoliovirus serum (Type 2) 10.46 "

Antipoliovirus serum (Type 3) ~ 10.48

Clostridium botulinum Type A antitoxin O.

136

Clostridium botulinum Type В antitoxin 0.1740 "

Clostridium botulinum Type С antitoxin 0.0800 "

Clostridium botulinum Type D antitoxin 0.0121 "

Clostridium botulinum Type E antitoxin 0.0691 "

Naja antivenin 2.69 "

Clostridium welchii (perfringens) Type В antitoxin 0.0137 Clostridium welchii (perfringens) Type D antitoxin 0.0657

Swine erysipelas serum (anti-N) 0.14

Anti-Brucella abortus serum 0.091

Anti-swine-fever serum 0.89 "

A18/P&B/15 page 3

International Standards International Units

Penicillin (Second Standard) 0.0005988 mg

Phenoxymethylpenicillin

Streptomycin (Second Standard) Dihydrostreptomyc in

Bacitracin (Second Standard) Tetracycline

Chlortetracycline Oxy t etгас ус1ine Erythromyc in Polymyxin В Nystatin Amphotericin В Vane omyc in Oleandomycin

Oxytocic, vasopressor and anti-diuretic substances

(Third Standard) 0.5

Prolactin (Second Standard) 0.04545

Corticotrophin (Third Standard) 1.0

Thyrotrophin 13*5

Growth hormone 1.0

Serum gonadotrophin 0.25

Chorionic gonadotrophin (Second Standard) 0.001279

Insulin (Fourth Standard) 0.04l67

Heparin (Second Standard) 0.0077

Vitamin (Second Standard) 0.000025

Hyaluronidase 0.1

Digitalis (Third Standard) 76.0

(b) that these standards and units or their equivalents be cited in the relevant national pharmacopoeias;

(c) that where applicable, these standards and units or their equi­

valents be recognized in relevant national regulations;

0.001282 O.OOI316 O.OI

35

0.00101

0.001

0.00111 O.OOIO53 O.OOOI27 О.ОООЗЗЗ 0.001064 0.000993 O.OOII76

A18/P&B/15 page 4

(d.) that in those countries which do not possess a national pharmacopoeia or national standards the potency appearing on the labels of biological products be expressed in international units;

2. INVITES the Director-General to inquire periodically from Members regarding the use being made of international standards in their countries.