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Insights
In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
INTERPRETATION
For Injectable Complex Generics, China Has Special CMC Requirements
May 11, 2023
INTERPRETATION
CMC Post-approval Changes to Chemical Drugs in China: Categories and Dossier Requirements
Mar 31, 2023
INTERPRETATION
China Medical Device Classifications for Marketing Authorization
Mar 30, 2023
REPORT
[New Resource] China Marketing Authorization Holder (MAH)'s Responsibilities for Drug Quality
Mar 24, 2023
Q&A
China CDE Q&A on DMF Filing and Drug Application's Electronic Submission
Mar 15, 2023
INTERPRETATION
[Updated] Drug Application Fees for FY 2023 in China and the U.S.
Feb 10, 2023
Q&A
China CDE Q&A on Drug Application's Electronic Submission and More
Jan 18, 2023
INTERPRETATION
Comparing First Generic Drugs in China and the US
Nov 25, 2022
INTERPRETATION
Decoding China's Good Pharmacovigilance Practices (GVP)
Oct 31, 2022
INTERPRETATION
China Clinical Trial Application (CTA) / Investigational New Drug (IND) Application Procedures
Oct 20, 2022
INTERPRETATION
How to Get China's Marketing Authorization for OTC Drugs
Sep 16, 2022
INTERPRETATION
How to Sell OTC Drugs to China via Cross-Border E-Commerce
Sep 16, 2022
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