Announcement of CFDA on Issuing Drugs by Generic Drug Quality and Efficacy Consistency Evaluation (First Batch)


Release time:

2017-12-29

According to the "the People's Republic of China Drug Administration Law", "Opinions of the State Council on Reforming the Drug and Medical Device Review and Approval System" (Guo Fa [2015] No. 44), "Opinions of the General Office of the State Council on Carrying out the Evaluation of the Quality and Efficacy Consistency of Generic Drugs" (Guo Ban Fa [2016] No. 8), "Announcement on Matters Concerning the Evaluation of the Quality and Efficacy Consistency of Generic Drugs" (China Food Announcement No. 100, 2017) provisions, after review, a catalog of drug application varieties that meet the requirements for the quality and efficacy consistency evaluation of generic drugs is now released (see annex). The instructions, corporate research reports and bioequivalence test data information of the above varieties can be logged on to the State Food and Drug Administration Drug Review Center website (www.cde.org.cn) Query.

 

It is hereby announced.

 

Annex: List of Varieties Approved for Quality and Efficacy Consistency Evaluation of Generic Drugs in December 2017

 

State Food and Drug Administration

December 28, 2017

  Annex to Announcement No. 173 of 2017. doc