INTERPRETATION

China DMF Filing, Review & Approval System for APIs, Pharmaceutical Excipients & Packaging Materials

by Grace Wang
May 07, 2021

China's drug review & approval system has undergone substantial reforms since it joined the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) in 2017. One of the reforms is changing the registration system for active pharmaceutical ingredients (APIs), pharmaceutical excipients and packaging materials (the three will be referred to as AEPs in the following text) to DMF filing.

Grace Wang
ChemLinked Regulatory Analyst
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