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Insights
In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
REPORT
2023 China CDE Drug Evaluation Report
Apr 24, 2024
Q&A
China CDE Q&A on API Filing, Equivalence Evaluation, and Clinical Trial Registration
Nov 01, 2023
REPORT
2022 China CDE Drug Evaluation Report
Sep 21, 2023
INTERPRETATION
For Injectable Complex Generics, China Has Special CMC Requirements
May 11, 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
How to Get China's Marketing Authorization for OTC Drugs
Sep 16, 2022
Q&A
China CDE Q&A | BE Study, Reference Listed Drug, and Quality & Therapeutic Equivalence Evaluation
Aug 30, 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
INTERPRETATION
How to Submit Abbreviated New Drug Application (ANDA) for Generic Drugs in China
May 18, 2022
INTERPRETATION
China Chemical Drug Registration Classification
Oct 18, 2021
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