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Guidelines on the Use of International Nonproprietary Names (INNs) for Pharmaceutical Substances
(1997; 41 pages) View the PDF document
Table of Contents
Open this folder and view contents1. General introduction
Open this folder and view contents2. Elements in the INN system
Open this folder and view contents3. Principles for selection of INNs
View the document4. Protection of INNs
Open this folder and view contents5. How to apply for an INN
View the document6. References for supporting material
View the documentAnnex 1: Background information on the INN programme
View the documentAnnex 2: General principles for guidance in devising international nonproprietary names for pharmaceutical substances
View the documentAnnex 3: List of common stems used in the selection of INNs
View the documentAnnex 4: Specific groups of biological compounds
View the documentAnnex 5: WHA46.19 - Nonproprietary names for pharmaceutical substances
View the documentAnnex 6: Procedure for the selection of international nonproprietary names for pharmaceutical substances
View the documentAnnex 7: Applications for INNs through national authorities (addresses)
View the documentAnnex 8: INN request form
 

Annex 1: Background information on the INN programme

The activities of national nomenclature commissions are coordinated in order to achieve international standardization in nomenclature under the auspices of WHO according to article 2a and 2u of its constitution (adopted in 1946 in New York):

“In order to achieve its objective, the functions of the World Health Organization shall be:

(a) to act as the directing and coordinating authority on international health work; ...
(u) to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products; ...”

The WHO programme on the selection of international nonproprietary names (INN) emerged really as an extension of the WHO programme on the unification of pharmacopoeias and the preparation of the International Pharmacopoeia requested by the very first World Health Assembly in July 1948 in resolution WHA1.27. The meeting of an Expert Committee on Unification of Pharmacopoeias in 1949 studied the preparation of general rules for nomenclature, and drew up a plan that was adopted in 1950 by a resolution of the World Health Assembly (WHA3.11).

The World Health Organization's (WHO) international nomenclature programme was thus established in 1953 when Member countries adopted a resolution at the World Health Assembly officially initiating the programme on International Nonproprietary Names (INN) for pharmaceutical substances [French: Dénominations Communes Internationales]; [Spanish: Denominaciones Comunes Internacionales - DCI].

The official “Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances” and the “General Principles for Guidance in Devising International Nonproprietary Names for Pharmaceutical Substances” on which the whole programme is based were adopted by the Executive Board in 1955 in resolution EB15.R7. The Procedure has remained unchanged - except for the replacement of the words “INNs for Pharmaceutical Preparations” by “INNs for Pharmaceutical Substances” (res. EB43.R9). However, the General Principles have evolved and revisions were regularly approved in the reports of the Sub-Committee meetings submitted to the Executive Board. Since 1969 the Director-General is authorized by the Executive Board to make such revisions of the General Principles as may seem desirable in the light of advances in science and of experience as may be suggested by the members of the Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations designated to deal with the selection of nonproprietary names (INN experts) in accordance with the above-mentioned Procedure (res. EB37.R9).

From 1950 onwards the programme was dealt with by the Sub-Committee of the Expert Committee on the Unification of Pharmacopoeias. The first task of the Sub-Committee was to establish contacts with national pharmacopoeia commissions that had already established programmes on the unification of drug nomenclature as those carried out under the Comité de Nomenclature of the Commission permanente de la Pharmacopée Française, the Nomenclature Committee of the British Pharmacopoeia Commission, the Council of Drugs of the American Medical Association in the USA and the Nomenclature Committee of the Nordic Pharmacopoeia Council in the Scandinavian countries. The purpose of these contacts was to coordinate the activities of such existing national nomenclature programmes.

Between 1950 and 1966 the Sub-Committee met 16 times. The earlier meetings were concerned with developing the Procedure and the General Principles and the first list of proposed INNs was only published in 1953. In 1967 the Sub-Committee became the Expert Committee on Nonproprietary Names for Pharmaceutical Preparations and later the Expert Committee on Nonproprietary Names for Pharmaceutical Substances. This Expert Committee only met in 1967, 1968, 1970 and 1975. In the other years, and since 1976, the meetings were held in a less formal way and referred to as Consultations on the Selection of INNs. The justification for this less formal approach is that the main report of the Committee consists of the officially published INNs selected during its meetings.

The composition of the INN meetings over almost 40 years has been characterized by a great stability. The average number of participants is 6-8 experts, mostly people with responsible positions in-or secretaries of - national nomenclature commissions, and only some 30 people have been involved over the years. At present the Expert group is composed of experts from France, Indonesia, Japan, Nigeria, Poland, Spain, the United Kingdom and USA.

BAN: British Approved Name
DCF: Dénomination Commune Française
DCIt: Denominazione Comune Italiana
JAN: Japanese Accepted Name
USAN: United States Approved Name

WHO Bulletin OMS. Vol 73 1995

 

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