China CFDA releases 2016 Drug Review Annual Report

China Food and Drug Administration (CFDA) recently released the 2016 Drug Review Annual Report. The Annual Report describes the general situation of drug registration acceptance, review and approval in 2016, and analyzes the data of acceptance and review in 2016 for chemical drugs, traditional Chinese medicines and biological products respectively.

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CFDA Official Explains the Verification of New Drug Clinical Trial Data

An official from the Department of Drug and Cosmetics Registration of CFDA was interviewed about “the issues on authenticity of clinical trial data in new drug registration applications” reported by media.

The official introduced that according to the Announcement on Performing Self-Examination & Verification of Drug Clinical Trial Data issued … Continue reading

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