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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)
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