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[e-drug] WHO list of bioequivalency requirements? (2)

E-DRUG: WHO list of bioequivalency requirements? (2)
----------------------------------------------------

Reference is made to the request for information about the WHO
requirements for bioequivalence. 

The WHO document on "MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS:
GUIDELINES ON REGISTRATION REQUIREMENTS TO ESTABLISH INTERCHANGEABILITY"
was adopted by the WHO Expert Committee on Specifications for Pharmaceutical
Preparations. 

The guidelines are available in the 34th Report of this WHO
Expert Committee (WHO Expert Committee on Specifications for Pharmaceutical
Preparations.  Thirty-fourth report.  Geneva, World Health Organization,
1996 (WHO Technical Report Series, No. 863, Annex 9) and Quality Assurance
of Pharmaceuticals, Vol. 1. Geneva, World Health Organization, 1997).  

A revision is underway and was discussed during the 39th Session of the same
WHO Expert Committee. 

The related revised draft under discussion is available on the following 
website:  http://www.who.int/medicines b:Quick
Links b:Expert Committee on Specifications for Pharmaceutical Preparations
b:39th WHO Expert Committee.

The WHO Expert Committee on Specifications for Pharmaceutical
Preparations also discussed the necessity to update and review the list of
international comparator products for bioequivalence assessment of
interchangeable multisource (generic) products (WHO Expert Committee on
Specifications for Pharmaceutical Preparations.  Thirty-sixth report.
Geneva, World Health Organization, 2002 (WHO Technical Report Series, No.
902, Annex 11);  URL:
http://www.who.int/medicines/strategy/quality_safety/stqsmnorms.shtml).  

Due to globalization, mergers and updates of the WHO Model List of Essential
Medicines, an update of the products listed was considered necessary. 


Sabine Kopp, PhD
Quality Assurance & Safety: Medicines
World Health Organization
20, av. Appia
CH-1211 Geneva 27
Fax: +41 22 791 4730
kopps@who.int
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