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Announcement ofGeneric Drugs (First Batch) (2017 No. 173)
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Announcement of the General Administration of the People's Republic of China on the Issue of Conformity Evaluation of the Quality and Effectiveness of Generic Drugs (First Batch) (2017 No. 173)
According to the "People's Republic of China Drug Administration Law", "Opinions of the State Council on Reforming the System for the Review and Approval of Drugs and Medical Devices" (Guo Fa [2015] No. 44), and "Opinions of the General Office of the State Council on the Consistency Evaluation of the Quality and Efficacy of Generic Drugs" (Guobanfa [2016] No. 8), the "Announcement on Matters Concerning the Consistency Evaluation of the Quality and Efficacy of Generic Drugs" (State Food and Drug Administration Announcement 2017 No. 100), after review, are now issued A catalogue of drug application varieties that meet the requirements for the consistency evaluation of the quality and efficacy of generic drugs (see attachment). Information on the above-mentioned species, company research reports and bioequivalence test data can be found on the website of the State Food and Drug Administration's Drug Evaluation Center ( www.cde.org.cn). Special announcement.
Attachment: List of varieties approved for consistency and evaluation of quality and efficacy of generic drugs in December 2017
State Food and Drug Administration
December 28, 2017
