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Regulatory News
5/31/2025
NMPA Issues New Regulations on Experimental Research of Narcotic and P...
5/31/2025
NMPA Reopens Comment on Draft Announcement for Strengthening Oversight...
5/29/2025
CDE Solicits Comments on Draft Technical Considerations for NMR Studi...
5/29/2025
CDE Issues Guideline on Production Site Change Research for Licensed B...
5/29/2025
CDE Launches “Starlight Plan” to Encourage Pediatric Antitumor Drug ...
5/29/2025
CDE Issues Guideline on Safety Assessment and Reporting in Pediatric D...
5/22/2025
CDE Issues the Guideline on Clinical Trials for Alzheimer's Disease Dr...
5/20/2025
CDE Seeks Feedback on Draft Guidelines for Designing Clinical Trials I...
5/20/2025
CDE Solicits Feedback on Draft Guidelines for Writing Elderly Patient ...
5/20/2025
CDE Seeks Comments on Draft Guideline for Age-Friendly Design in Innov...
5/20/2025
CDE Solicits Comments on the 94th Batch of Reference Formulations for ...
5/16/2025
NMPA Orders Package Insert/Label Update for Ranitidine Injection Amid ...
5/14/2025
CDE Issues the List of Reference Formulations for GQCE Studies (92nd B...
5/14/2025
Six Drugs Granted Priority Review as China Registers Over 1,100 Produc...
5/7/2025
CDE Seeks Comments on Draft Guidelines for Subject Selection in Bioequ...
5/7/2025
CDE Publicizes the List of Reference Formulations for Generic Chemical...
5/6/2025
China Seeks Feedbacks on Draft Guideline for Risk Management Plan Duri...
5/6/2025
China Seeks Feedbacks on ICH Q1 Stability Testing Guideline Draft
5/6/2025
China Announces Ambitious Plan to Optimize Primary Healthcare System b...
4/29/2025
China NMPA Suspends Digoxin API Imports from VITAL LABS
4/22/2025
China Seeks Feedback on ICH Draft Guideline M13B for Biowaivers of Add...
4/22/2025
CDE Issues the List of Reference Formulations for GQCE Studies (91st B...
4/19/2025
China Issues New Guidelines to Streamline Mainland Registration for Or...
4/10/2025
China Revises Military Drug Administration Measures to Strengthen Over...
4/8/2025
CDE Solicits Comments on Draft Q&A for CMC Issues in rAAV-Based In Vi...
4/7/2025
China Receives 2.6 Million ADR Reports in 2024, Severe Cases Make Up 1...
4/7/2025
NMPA Mandates Digital QR Code System for Drug Manufacturing Licenses
4/7/2025
NMPA Solicits Comments on the Announcement on Matters Related to the I...
4/5/2025
China and WHO Collaborate on Quality Management Training to Boost Vacc...
3/31/2025
CDE Solicits Comments on the Draft Technical Specification of ICH M11:...
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