To implement the relevant requirements in the Opinions of the General Office of the State Council on Carrying out Quality and Efficacy Consistency Evaluation of Generic Drugs (State Council Office Issuance No. 8[2016]) and the Announcement of the General Office of the State Council on Relevant Matters concerning Carrying out Quality and Efficacy Consistency Evaluation of Generic Drugs (Announcement No. 106 [2016] by the China Food and Drug Administration), the China Food and Drug Administration has organized to formulate the Guideline on the Research On-site Inspection for Quality and Efficacy Consistency Evaluation of Generic Drugs, Guideline on the Production On-site Inspection for Quality and Efficacy Consistency Evaluation of Generic Drugs, Guideline on Clinical Trial Data Inspection for Quality and Consistency Evaluation of Generic Drugs, and the Guideline on For-cause Inspection for Quality and Consistency Evaluation of Generic Drugs, which are hereby promulgated.

It is hereby notified.

China Food and Drug Administration
May 16, 2017