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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
China DMF Requirements for CMC Post-approval Changes to Chemical Drugs
Mar 31, 2023
INTERPRETATION
China Medical Device Classifications for Marketing Authorization
Mar 30, 2023
INTERPRETATION
[Updated] Drug Application Fees for FY 2023 in China and the U.S.
Feb 10, 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
INTERPRETATION
How to Get Drug Marketing Authorization Holder (MAH) Agency Services in China
Aug 26, 2022
INTERPRETATION
Leading Contract Research Organizations (CRO) in China
May 31, 2022
INTERPRETATION
China Abbreviated New Drug Application (ANDA) for Generic Drugs
May 18, 2022
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