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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
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 Clinical Trial Application (CTA) / Investigational New Drug (IND) Application Procedures
Oct 20, 2022
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
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
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