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Insights
In-depth regulation interpretation, authoritative policy insights shared by our experts and specialists.
REPORT
2022 China CDE Drug Evaluation Report
Sep 21, 2023
INTERPRETATION
For Injectable Complex Generics, China Has Special CMC Requirements
May 11, 2023
INTERPRETATION
Decoding China's Good Pharmacovigilance Practices (GVP)
Oct 31, 2022
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
China Abbreviated New Drug Application (ANDA) for Generic Drugs
May 18, 2022
Q&A
FAQ on Rare Disease Drugs (Orphan Drugs) in China
Apr 07, 2022
REPORT
China Drug Evaluation Report 2020-Reform of Drug Review & Approval System
Aug 27, 2021