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Insights
In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
Q&A
China CDE Q&A on Drug Application's Electronic Submission and More
Jan 18, 2023
INTERPRETATION
China Marketing Authorization Holder (MAH)'s Responsibilities for Drug Quality
Jan 16, 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
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
Q&A
China CDE Q&A | BE Study, Reference Listed Drug, and Quality & Therapeutic Equivalence Evaluation
Aug 30, 2022
INTERPRETATION
How to Get Drug Marketing Authorization Holder (MAH) Agency Services in China
Aug 26, 2022
Q&A
China CDE Q&A | Drug Registration Applications & Clinical Trials
Aug 08, 2022
REPORT
2021 China CDE Drug Evaluation Report
Jul 04, 2022
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