China Releases Guidance for Declaration of Chemical Drug Changes

by Grace Wang Mar 19, 2021

On Feb. 10, 2021, the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) issued and started implementing the Guidance for Acceptance and Review of Chemical Drug Changes (Trial) 1. The document addresses supplemental applications that entail the reviews of state-level drug regulatory authorities, including those submitted during clinical trials.

Grace Wang
ChemLinked Regulatory Analyst
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