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Insights
In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
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
China Abbreviated New Drug Application (ANDA) for Generic Drugs
May 18, 2022
INTERPRETATION
China Chemical Drug Registration Classification
Oct 18, 2021
REPORT
China Drug Evaluation Report 2020-Disapproval Reasons
Aug 27, 2021
REPORT
China Drug Evaluation Report 2020-Critical Numbers
Aug 27, 2021
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