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Insights
In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
INTERPRETATION
Decoding China's Good Pharmacovigilance Practices (GVP)
May 15, 2024
REPORT
2023 China CDE Drug Evaluation Report
Apr 24, 2024
INTERPRETATION
China's Drug Supply Regulations Come into Effect
Jan 01, 2024
REPORT
Post-approval Changes to Active Pharmaceutical Ingredients (APIs), Excipients, and Packaging Materials (AEPs) in China
Dec 13, 2023
INTERPRETATION
Indonesia Drug Registration Process
Nov 16, 2023
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
REPORT
[Updated] China Pharma Guidelines: Nonclinical Study, Clinical Trial, Marketing Authorization and More
Oct 17, 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
China DMF Requirements for CMC Post-approval Changes to Chemical Drugs
Mar 31, 2023
INTERPRETATION
China Medical Device Classifications for Marketing Authorization
Mar 30, 2023
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