Start of generic drug re evaluation project
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Last Update: 2014-01-23
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Source: Internet
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Author: User
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According to the analysis of the main factors influencing the differences in drug quality recently released by the pharmaceutical research and development industry committee of China Association of foreign funded enterprises, there are obvious quality differences in the approved drugs in China, especially the task of re evaluation of generic drugs is arduous The majority of the existing 189000 drug marketing licenses in China are generic drugs, most of which have not been compared with the imitated products, and only a few of which have been tested for bioequivalence Therefore, in 2012, the State Council issued the 12th Five Year Plan for national drug safety, which clearly requires that generic drugs approved before the implementation of the measures for the administration of drug registration revised in 2007 should be evaluated for quality consistency with generic drugs in stages and batches, and "supplementary courses for history" should be carried out.
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