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Regulatory News
5/15/2026
CDE Issues New TCM Post-Approval Change Review Guidelines
5/15/2026
CDE Issues Revised Review Guideline for Biologics Change Applications
5/15/2026
CDE Releases Revised Review Guideline for Chemical Drug Change Applica...
5/15/2026
CDE Releases Operational Procedures for Drug Trial Data Protection Sys...
5/15/2026
CDE Issues Filing Requirements for Drug Data Protection Applications
5/15/2026
China Introduces Drug Trial Data Protection Rules to Strengthen Pharma...
5/14/2026
Singapore and China Sign MoU to Strengthen Cooperation on Health Produ...
5/14/2026
China Launches Sweeping Crackdown on Pharmaceutical Kickbacks and Sale...
5/13/2026
2025 Annual Drug Evaluation Report: Chinese Applications and Reviews H...
5/12/2026
Singapore, China Expand Regulatory Partnership to Include Gene and Cel...
5/11/2026
CDE Releases Draft MSC Stem Cell Product Guideline for Public Consulta...
5/11/2026
NMPA Releases 105th Batch of Generic Drug Reference Formulations
5/11/2026
NHC Seeks Comments on Revised Human Genetic Resources Regulation Imple...
5/8/2026
CDE Issues Revised Technical Guideline for Recombinant Insulin Product...
5/8/2026
China Reports 3.05M ADRs in 2025, Flags Oncology and Anti-Infective Ri...
5/8/2026
China Unveils Tougher Nationwide Rules Governing Medical Representativ...
5/6/2026
NHC Seeks Public Feedback on Updated Rules for Managing Narcotic and P...
5/6/2026
China Formalizes Approval Framework for Clinical Use of Biomedical New...
5/6/2026
NHC Releases Trial Rules for Approving Clinical Use of Biomedical New ...
5/6/2026
NHC Issues Interim Rules Defining Boundaries Between Biomedical New Te...
4/29/2026
CDE Seeks Feedback on Draft Bioanalytical Lab Compliance Report for Cl...
4/29/2026
CDE Opens Consultation on BNCT Drug Development Guideline
4/28/2026
China Moves to Expand Maternity Insurance Coverage in Draft Healthcare...
4/27/2026
China NMPA Releases Updated Procedures for Conditional Drug Approvals
4/24/2026
China Seeks Feedback on New Approval Framework for Clinical Translati...
4/24/2026
CDE Issues New Framework for Post-Approval Changes and Registration Te...
4/23/2026
CDE Issues New Guidance Table on Post-Approval Changes and Triggering ...
4/22/2026
CDE Opens Public Consultation on 106th Batch of Reference Formulations...
4/22/2026
China Suspends Import and Use of Colchicine API from Two Indian Manufa...
4/22/2026
China Unveils Landmark Drug Pricing Framework to Boost Innovation and ...
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