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 (PANDRH): Technical Working Groups: Bioequivalence Working Group. Framework for Implementation

Name:(PANDRH): Technical Working Groups: Bioequivalence Working Group. Framework for Implementation
Category: 1724
Link: (URL) PANDRH-WG_Operational_Strategy_for_BE_Implementation.pdf

Pan American Network for Drug Regulatory Harmonization (PANDRH): Technical Working Groups: Bioequivalence Working Group.  Framework for Implementation of Equivalence Requirements for Pharmaceutical Products: Document for Public Opinion.

The first part refers to scientific criteria for implementing therapeutic equivalence. In developing this part of the document, the WG/BE analyzed in detail the WHO document “Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability,” which was being prepared by the WHO Expert Committee for Pharmaceutical Preparations.

The second part of the document refers to the strategic framework for the implementation of studies of drug equivalence. This part describes the reality of the Region of the Americas, serving the special features of Latin America and considering that most of the multisource products (products of different origin and/or manufacturers) marketed in the region were approved in accordance with the drug registration requirements of each country at the time of their registration.

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Created On: 09/10/2008 17:57
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Last updated on: 09/10/2008 17:58

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