On August 27, 2020 China’s Center of Drug Evaluation (CDE) released a draft regulation listing 117 different drugs that will be exempt from Bioequivalence (BE) studies. The list of drugs was selected in accordance to “Announcement on the Implementation of The Evaluation of the Quality and Efficacy of Chemical Injection Imitations” issued by the National Bureau on May 14, 2020 (No. 62 of 2020).
CDE Draft ” List of Drugs with Clear Clinical Values that do not need reference Preparations ( BE/BA studies)” – GRP complimentary English translation.
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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations. To learn more, please contact us at email@example.com
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