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Regulatory News
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 ...
4/20/2026
China Seeks Feedback on ICH M8 eCTD v4.0 Implementation, Advancing Reg...
4/20/2026
CDE Issues New Technical Guidelines for IND-Enabling CMC Dossiers Cove...
4/20/2026
China Releases 104th Batch of Reference Formulations for Generic Drug ...
4/20/2026
China Seeks Public Input on New GSP Appendix for Retail Pharmacy Chain...
4/16/2026
China Moves Toward Value-Based Drug Pricing, Granting Greater Autonomy...
4/16/2026
China CDE Opens Consultation on Draft CMC Guideline for Therapeutic Bo...
4/14/2026
China Unveils New Drug Pricing Reform to Balance Innovation, Affordabi...
4/13/2026
China CDE Releases Patient-Centered Clinical Development Guideline for...
4/13/2026
China CDE Opens Public Consultation on Draft ARC CMC Guideline
4/10/2026
CDE Seeks Comments on New Technical Guideline for Staged Manufacturing...
4/9/2026
CDE Releases New Clinical Evaluation Guideline for IND Applications to...
4/9/2026
CDE Issues New Clinical Evaluation Guideline for Drug Marketing Applic...
4/8/2026
NMPA Adopts ICH M14 Guideline, Expanding China's Regulatory Framework ...
4/8/2026
NMPA Adopts ICH Q8, Q9 and Q10 Q&A (R5)
4/3/2026
NMPA Suspends Import, Sale and Use of Cadila's Amlodipine Besylate API...
4/3/2026
CDE Revises Drug R&D and Technical Review Communication Management Mea...
4/2/2026
NMPA Releases Implementation Opinions on "AI + Drug Regulation"
4/2/2026
NMPA Issues Notice on Advancing Segmented Manufacturing of Biologics
4/1/2026
China CDE Opens Public Consultation on 105th Batch of Chemical Generic...
3/31/2026
NMPA Moves to Strengthen China's Conditional Drug Approval Framework
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