China CDE to Disclose New Drugs' Technical Review Reports

China's Center of Drug Evaluation (CDE) recently announced that it would disclose the technical review reports and package inserts of all new drugs approved since Sept. 1, 2016. The disclosure would also extend to generic drugs and other applications in the future.
by Grace Wang Feb 24, 2021

On Feb. 23, 2020, China's Center of Drug Evaluation (CDE) issued the Work Rules for the Disclosure of New Drugs' Technical Reports (Trial) 1. The document says, from Jun. 1, 2021, CDE will release the technical review reports and package inserts of all new drugs approved since Sept. 1, 2016. Innovative new drugs, improved new drugs, and imported original or improved drugs with overseas marketing authorization are the major types covered.

Grace Wang
ChemLinked Regulatory Analyst
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