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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 API Filing, Equivalence Evaluation, and Clinical Trial Registration
Nov 01, 2023
Q&A
FAQs on China's Human Genetic Resources (HGRs)
Oct 24, 2023
Q&A
China CDE Q&A on DMF Filing and Drug Application's Electronic Submission
Mar 15, 2023
Q&A
China CDE Q&A on Drug Application's Electronic Submission and More
Jan 18, 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
Q&A
China CDE Q&A | Drug Registration Applications & Clinical Trials
Aug 08, 2022
Q&A
FAQ on Rare Disease Drugs (Orphan Drugs) in China
Apr 07, 2022