Insights
In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
Hot topic
REPORT
Post-approval Changes to Active Pharmaceutical Ingredients (APIs), Excipients, and Packaging Materials (AEPs) in China
Dec 13, 2023
REPORT
[Updated] China Pharma Guidelines: Nonclinical Study, Clinical Trial, Marketing Authorization and More
Oct 17, 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 Submit Abbreviated New Drug Application (ANDA) for Generic Drugs in China
May 18, 2022
