Preview

Regulatory Research and Medicine Evaluation

Advanced search

International nonproprietary names of drugs: requirements for an application and order of examination and registration of the world health organization

Abstract

Brief information about the program of the World Health Organization (WHO) for International Nonproprietary Names (INN) for drugs and the role of the INN in the sphere of circulation of medicines is represented. The general principles of INN selection and requirements for development applications for the INN are described. The assignment of an INN of the pharmaceutical substance is the highest criterion for recognition by the international expert community of innovative medicines created by a particular developer and makes it possible to objectively judge the contribution of different countries in global health. Questions of functioning of the national system of the selection and introduction of INN for domestic original pharmaceutical medicines have the high urgency.

About the Authors

V. V. Dudchenko
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation


A. N. Yavorskiy
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation


Yu. V. Olefir
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation


N. D. Bunyatyan
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation


References

1. The development strategy of the pharmaceutical industry of the Russian Federation for the period until 2020 (Strategy «Farma2020») (in Russian).

2. The strategy of the drug provision of the population of the Russian Federation until 2025 (in Russian).

3. Resolution WHA 3.11 «Nonproprietary Names of Medicines» (in Russian).

4. Guidelines on use of International Nonproprietary Names (INNs) for Pharmaceutical Substances. WHO/PHARM S/Nom 1570. Geneva; WHO: 1997.

5. International Nonproprietary Names: revised procedure. Procedure for the selection of recommended international nonproprietary names for pharmaceutical substances. EB115.R4. Geneva; WHO: 2005. Available from: http://policy.who.int.

6. International Nonproprietary Names (INN) for biological and biotechnological substances (a review). Document WHO/EMP/RHT/TSN/2014.1.

7. Forty-sixth World Health Assembly Resolution on Nonproprietary Names for Pharmaceutical Substances. Document WHA46.19. Geneva; WHO: 1993. Available from: http://policy.who.int.

8. Global strategy and plan of action on public health, innovation and intellectual property. Available from: http://www.who.int/phi/publications/Global_Strategy_Plan_Action.pdf?ua=1.

9. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Document WHO/EMP/RHT/TSN/2013.1. Geneva; WHO: 2013.

10. International Nonproprietary Names (INN) for pharmaceutical substances. Names for radicals and groups: comprehensive list. Document WHO/EDM/QSM/2004.6. Geneva; WHO: 2004.

11. Graphic presentation of chemical formulae in the publication International Nonproprietary Names (INN) for pharmaceutical substances. Document WHO/PHARM/95.579. Geneva; WHO: 1995.

12. Pharmacological action and therapeutic use of drugs: a list of terms. Document PHARM/96.320. Geneva; WHO: 1996.

13. WHO Drug Information. Vol. 29, № 1, 2015. Recommended INN: List 73.

14. Korzhavyh EA, Yavorskiy AN. Trade names of medicines. Moscow: FGBU «NCESMP» Minzdrava Rossii; 2013 (in Russian).

15. Rational choice of the names of medicines. Guidelines. Moscow: FGBU «NCESMP» Minzdrava Rossii; 2012 (in Russian).


Review

For citations:


Dudchenko V.V., Yavorskiy A.N., Olefir Yu.V., Bunyatyan N.D. International nonproprietary names of drugs: requirements for an application and order of examination and registration of the world health organization. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(2):29-34. (In Russ.)

Views: 1267


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 3034-3062 (Print)
ISSN 3034-3453 (Online)