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Insights
In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
REPORT
2021 China CDE Drug Evaluation Report
Jul 04, 2022
INTERPRETATION
Leading Contract Research Organizations (CRO) in China
May 31, 2022
INTERPRETATION
How to Submit Abbreviated New Drug Application (ANDA) for Generic Drugs in China
May 18, 2022
Q&A
FAQ on Rare Disease Drugs (Orphan Drugs) in China
Apr 07, 2022
INTERPRETATION
China's Marketing Authorization Holder (MAH) System
Nov 25, 2021
INTERPRETATION
China Biological Product Registration Classification
Oct 19, 2021
INTERPRETATION
China Chemical Drug Registration Classification
Oct 18, 2021
INTERPRETATION
How China Regulates Aesthetic Medicines—Thermage, Hyaluronic Acid, and Collagen
Oct 18, 2021
INTERPRETATION
IVD Reagent Registration and Filing in China
Oct 08, 2021
INTERPRETATION
Medical Device Registration and Filing in China
Sep 18, 2021
REPORT
China Drug Evaluation Report 2020-Reform of Drug Review & Approval System
Aug 27, 2021
REPORT
China Drug Evaluation Report 2020-Disapproval Reasons
Aug 27, 2021
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