China’s CDE Announces 95th Batch of Reference Preparations for Public Comment
China’s Center for Drug Evaluation (CDE) has released the 95th batch of reference preparations for...
Policy / Regulatory
China Ministry of Finance Restricts EU-Imported Medical Devices in Government Procurement Over RMB45 Million
China’s Ministry of Finance (MoF) has issued the “Notice on Implementing Relevant Measures for EU-Imported...
NMPA Unveils Measures to Support High-End Medical Device Innovation with Full Lifecycle Regulation
China’s National Medical Products Administration (NMPA) last week released the “Measures to Optimize Full-lifecycle Regulation...
NHSA Unveils Plans for 2025 National Drug List Adjustments and Commercial Insurance Drug List
This week, China’s National Healthcare Security Administration (NHSA) released two draft documents detailing a plan...
China Unveils Measures to Boost Innovative Drug Development With Insurance Data Support
China’s National Healthcare Security Administration (NHSA) and National Health Commission (NHC) jointly released the “Several...
China Proposes Healthcare Security Law to Strengthen Medical Insurance System
China’s National Healthcare Security Administration (NHSA) last week released the “Healthcare Security Law (draft proposal)”,...
FDA Removes REMS Requirements for BCMA- and CD19-Targeted CAR-T Therapies
The U.S. Food and Drug Administration (FDA) last week announced the removal of Risk Evaluation...
China Raises Subsidy for Basic Public Health Services, Targets Vulnerable Groups
China’s National Health Commission (NHC) released the “Notice on Improving Basic Public Health Services in...
NHSA Emphasizes Management of Designated Medical Institutions for Healthcare Quality
The National Healthcare Security Administration (NHSA) this week released a notification emphasizing the importance of...
NHSA Implements Region-Based Pricing System for Medical Services
China’s National Healthcare Security Administration (NHSA) this week issued the “Notice on Optimizing Medical Service...
Beijing Tightens Price Risk Management for Scarce Medications
The Beijing Municipal Medical Insurance Bureau issued the “Notice on Further Strengthening Price Risk Management...
NMPA’s CDE Reports 4,900 Clinical Trial Filings for Innovative Drugs in 2024
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released its...
CDE Issues New Requirements for IND Applications of Innovative Drugs
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) this week...
FDA Launches ‘Elsa’ AI Tool to Enhance Staff Efficiency in Regulatory Processes
The U.S. Food and Drug Administration (FDA) announced the launch of an artificial intelligence (AI)...
FDA Launches Immediate Review of Clinical Trials Involving Cell Transfer to Hostile Countries
The U.S. Food and Drug Administration (FDA) this week announced an immediate review of new...
FDA Launches Commissioner’s National Priority Voucher Program for Accelerated Drug Reviews
The U.S. Food and Drug Administration (FDA) this week announced the launch of the Commissioner’s...
China’s NHC Unveils 2025 Healthcare Reforms to Tackle Procurement and Service Irregularities
China’s National Health Commission (NHC) has released the 2025 Key Tasks for Rectifying Improper Practices...
NMPA Issues Immediate Guidelines for NGS-Related IVD Reagent Classification
China’s National Medical Products Administration (NMPA) released the “Guidelines for Classification Definition of Next-Generation Sequencing...
China Updates Class 3 Hospital Accreditation Standards for 2025
Last month, China’s National Health Commission officially issued the Class 3 Hospital Accreditation Standards (2025...
China’s CDE Seeks Feedback on Advanced Therapy Medicinal Products Guidelines
China’s Center for Drug Evaluation (CDE) released a draft guideline titled “Scope, Classification and Definitions...