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...
Policy / Regulatory
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...
State Council Issues Opinions to Advance Shenzhen’s Healthcare Reforms
The General Office of the State Council released the “Opinions on Further Advancing Shenzhen’s Comprehensive...
NHSA Strengthens Pharmaceutical Pricing and Procurement Credit Evaluation Mechanism
The National Healthcare Security Administration (NHSA) issued a notification this week to refine its credit...
China Issues Whistleblower Incentives for Drug and Medical Device Safety Violations
China’s National Medical Products Administration (NMPA), Ministry of Finance (MoF), and State Administration for Market...
China’s National Health Commission Mandates Labor Pain Management Services Expansion
China’s National Health Commission (NHC) issued a notification mandating the comprehensive promotion of labor pain...
EU Bars Chinese Medical Device Makers from Public Tenders Over €5M for Five Years
China Central Television (CCTV) reported that EU member states have voted under the International Procurement...
FDA Rejects Data from Two Chinese Testing Labs Over Compliance Concerns
The U.S. Food and Drug Administration (FDA) late last week issued General Correspondence Letters to...