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Insights
In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
INTERPRETATION
Decoding China's Good Pharmacovigilance Practices (GVP)
May 15, 2024
REPORT
2022 China CDE Drug Evaluation Report
Sep 21, 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
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