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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
REPORT
Post-approval Changes to Active Pharmaceutical Ingredients (APIs), Excipients, and Packaging Materials (AEPs) in China
Dec 13, 2023
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
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 | 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
REPORT
2021 China CDE Drug Evaluation Report
Jul 04, 2022
INTERPRETATION
China Drug Master File (DMF) for APIs, Pharmaceutical Excipients & Packaging Materials
May 07, 2021
REPORT
Selection of 2019 China Center for Drug Evaluation Annual Report
Mar 08, 2021