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Regulatory News
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
3/30/2026
NMPA Releases 103rd Batch of Generic Drug Reference Formulations Catal...
3/26/2026
China Issues New Guidelines to Standardize Pharmaceutical Logistics Na...
3/25/2026
China Seeks Public Input on Accelerating National Drug Traceability Sy...
3/25/2026
China Suspends Imports of Select Indian APIs Over GMP Violations
3/17/2026
CDE Issues Guideline on Dose Extrapolation for Neonates and Young Infa...
3/17/2026
CDE Seeks Comment on Draft Guideline for Advancing Oncology Drugs to F...
3/11/2026
China Releases Trial Guideline for Influenza Vaccine Clinical Studies
3/11/2026
China Issues Revised Technical Guideline for HPV Vaccine Clinical Tria...
3/11/2026
China Seeks Comments on Draft Technical Guideline for Rare Disease ERT...
3/9/2026
China Publishes 102nd Batch of Reference Formulations for Generics and...
3/9/2026
NMPA Seeks Input on Draft Guidelines for Quality Summaries of Therapeu...
3/5/2026
CDE Issues Guidance on Subject Selection for Oncology Drug Bioequivale...
3/4/2026
CDE Invites Feedback on Draft Technical Guideline for Preventive mRNA ...
3/4/2026
CDE Issues Technical Guideline on Clinical Trials for Drugs Treating C...
3/2/2026
CDE Issues Interim Guidelines for Synthetic Oligonucleotide Innovativ...
2/25/2026
CDE Solicits Comments on Batch 104 of Chemical Generic Reference Formu...
2/24/2026
China Prepares to Implement Landmark Regulations for Clinical Research...
2/24/2026
CDE Issues Guidelines on Benefit-Risk Assessment Using Multi-Regional ...
2/24/2026
CDE Releases Q&A Document on Development Safety Update Reports
2/24/2026
CDE Issues Guideline on Clinical Information for CAR-T Therapy Package...
2/12/2026
CDE Issues Draft Pharmaceutical Guidance for Rare Disease Chemical Dru...
2/9/2026
CDE Issues Technical Guideline for Generic Sodium Iodide [131I] Oral S...
2/5/2026
2026 National Conference on Drug Registration and Post-Market Regulati...
2/5/2026
CDE Issues Trial Guideline for Neuropathic Pain Drug Development
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