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CFDA Issued the Guidelines for Acceptance and Review of Conformance Evaluation of the Quality and Efficacy of Generic Drugs (to which Such Evaluation is Compulsory) and the Guidelines for Acceptance and Review of Conformance Evaluation of the Quality and
Date:2017-09-05
To implement the policies set forth in the Opinions of the State Council General Office on Carrying out Conformance Evaluation of the Quality and Efficacy of Generic Drugs (State Council General Office [2016] No. 8), according to the requirements set forth in the Announcement on Matters concerning the Conformance Evaluation of the Quality and Efficacy of Generic Drugs (CFDA Announcement [2017] No. 100) and other documents, CFDA organized the development of the Guidelines for Acceptance and Review of Conformance Evaluation of the Quality and Efficacy of Generic Drugs (to which Such Evaluation is Compulsory) and the Guidelines for Acceptance and Review of Conformance Evaluation of the Quality and Efficacy of Generic Drugs (that are Produced in the Same Line in China and Marketed in Europe, US and Japan) and related documents, which have been released on September 5, 2017.
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