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Regulatory News
10/13/2025
CDE Seeks Input on Draft Technical Requirements for Sodium Iodide [131...
10/13/2025
CDE Solicits Comments on Draft Guidelines for Bioequivalence Risk Asse...
10/13/2025
CDE Issues Guidance to Address Common Challenges in Pediatric Drug Dev...
10/13/2025
China Introduces New Regulations to Govern Clinical Research and Appli...
10/1/2025
China Rolls Out 2025 Pharmacopoeia to Sharpen Drug Oversight
9/30/2025
China Issues Detailed Rules on Pre-Approval Import of Overseas Drugs
9/29/2025
CDE Solicits Comments on Clinical Evaluation Guidelines for Drug Marke...
9/29/2025
CDE Seeks Public Input on Clinical Evaluation Guidelines for Drug Tria...
9/26/2025
CDE Solicits Comments on Draft ICH Q3E Guideline for Extractables and ...
9/23/2025
China Seeks Comments on Draft Technical Guidelines for Crystalline Fo...
9/22/2025
Study Compares Breakthru Therapy Designation Programs in the U.S. and ...
9/19/2025
China Seeks Feedback on 2025 Draft Rules for Drug Development and Reg...
9/19/2025
CDE Issues Technical Requirements for AAV-Based In Vivo Gene Therapy P...
9/19/2025
CDE Seeks Comments on Draft Guideline for Long-Acting Local Anesthetic...
9/17/2025
CDE Invites Public Comment on Draft Guidelines for CAR-T Cell Therapy ...
9/17/2025
CDE Solicits Opinions on Draft Q&A for Development Safety Update Repor...
9/17/2025
CDE Seeks Feedback on Reference Formulations for Chemical Generic Drug...
9/17/2025
CDE Solicits Comments on Draft Guidance for mRNA Vaccine Research
9/17/2025
China Seeks Feedback on New Guidelines for Adjuvanted Vaccines
9/13/2025
CDE Seeks Public Opinions on New HIV/AIDS Drug Guidelines
9/13/2025
CDE Releases New, Comprehensive Guidelines for Innovative Drug Trial A...
9/13/2025
CDE Introduces New Risk Management Guidelines for Innovative Drugs
9/13/2025
CDE Releases First Technical Guidelines for GLP-1 Drugs
9/13/2025
CDE Releases 96th Batch of Reference Formulations for Generic Drug Eva...
9/12/2025
China NMPA Drastically Shortens Drug Trial Review Times with New Polic...
9/12/2025
CDE Seeks Feedback on Draft Guidance for Post-Approval Changes in Biol...
9/12/2025
CDE Solicits Input on Draft Guidance for Chronic Rhinosinusitis with N...
9/12/2025
CDE Seeks Feedback on Draft Guidance for Depression Drug Clinical Tria...
9/12/2025
CDE Solicits Comments on Draft Guidance for Insomnia Drug Clinical Tri...
9/12/2025
U.S. House Passes Bill That Could Sever Much of U.S.-China Academic Re...
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