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Insights
In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
REPORT
Post-approval Changes to Active Pharmaceutical Ingredients (APIs), Excipients, and Packaging Materials (AEPs) in China
Dec 13, 2023
INTERPRETATION
China DMF Requirements for CMC Post-approval Changes to Chemical Drugs
Mar 31, 2023
REPORT
[New Resource] China Marketing Authorization Holder (MAH)'s Responsibilities for Drug Quality
Mar 24, 2023
INTERPRETATION
Comparing First Generic Drugs in China and the US
Nov 25, 2022
Q&A
China CDE Q&A | Biologics' R&D, Associated Review of APIs, Excipients, and Packaging Materials, Requirements for Changes, and More
Sep 05, 2022
INTERPRETATION
How to Get Drug Marketing Authorization Holder (MAH) Agency Services in China
Aug 26, 2022
INTERPRETATION
China's Marketing Authorization Holder (MAH) System
Nov 25, 2021
REPORT
Selection of 2019 China Center for Drug Evaluation Annual Report
Mar 08, 2021