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In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
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
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
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