NHSA Releases NRDL Value Assessment Guidelines, Prioritizing 8 Drug Categories for Real‑World Evaluation
China’s National Healthcare Security Administration (NHSA) this week released the Series of Guidelines for Real‑World...
Policy / Regulatory
NHSA Launches 6th VBP Tender for Medical Consumables in China, Targeting Drug-Coated Balloons
China’s National Healthcare Security Administration (NHSA) conducted the 6th volume-based procurement (VBP) tender for high-value...
China’s NHSA Launches Pre‑Communication Pilot for Reference Drugs, Targeting Category 1 Innovative Drugs
China’s National Healthcare Security Administration (NHSA) released the “Measures for Pre‑Communication on Reference Drugs (draft...
FDA Announces Flexible CMC Pathway for Cell and Gene Therapies to Accelerate Development
The FDA’s Center for Biologics Evaluation and Research (CBER) announced a flexible, lifecycle‑based approach to...
NHSA Launches Personal Healthcare Insurance Cloud Pilot Program
China’s National Healthcare Security Administration (NHSA) issued a notice inviting applications for pilot projects to...
China Expands Medical Insurance Personal Account Pooling Nationwide
China’s National Healthcare Security Administration (NHSA) and Ministry of Finance (MoF) jointly issued the “Notice...
NMPA Issues New Rules to Strengthen Pharmaceutical Contract Manufacturing Oversight
The National Medical Products Administration (NMPA) issued the “Announcement on Strengthening Supervision and Management of...
NMPA Issues Priority Review Guidelines for Clinically Urgent Overseas Drugs
The National Medical Products Administration (NMPA) issued Announcement No. 3, 2026 on further optimizing the review...
NMPA Releases Draft 102nd Reference Preparations List for Generic Drugs
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the...
CMS Unveils BALANCE Model to Expand GLP-1 Access for Medicare/Medicaid
The U.S. Centers for Medicare & Medicaid Services (CMS) unveiled the BALANCE Model (Better Approaches...
NHC Releases Fourth Batch Generic Drugs Catalogue, Prioritizing Innovation and Fertility Support
The National Health Commission (NHC) released the Fourth Batch of the National Catalogue of Encouraged...
China State Council Approves Revised Drug Administration Regulations, Accelerating Innovation Review
The State Council of China approved the Revised Draft of the Implementation Regulations of the...
Haihe Biopharma’s Risovalisib Enters China SPARK Project for Pediatric PIK3CA Disorders
Haihe Biopharma Co., Ltd. announced that risovalisib mesylate (CYH33), a highly potent and selective PI3Kα...
NMPA Releases 2025 Priority Approval Directory for Eight High-End Medical Device Categories
China’s National Medical Products Administration (NMPA) published the 2025 Edition of the Directory of High-End...
NDRC Expands Foreign Investment in Healthcare with 2025 Catalogue
The National Development and Reform Commission (NDRC) issued the “Catalogue of Industries Encouraging Foreign Investment...
NMPA Issues Internet Pharma Info Rules Requiring Record-Filing Display
China’s National Medical Products Administration (NMPA) released the “Announcement on the Provisions for the Administration...
CDE Reference Standards 101st Batch Seeks Public Feedback
China’s Center for Drug Evaluation (CDE) announced it is seeking public feedback on the 101st...
China Mandates Specialty Departments in Primary Care by 2030
The National Health Commission issued Guiding Opinions on Strengthening Construction of Characteristic Departments in Primary...
FDA Removes Key RWE Limitation, Allowing Drug and Device Submissions Without Individual Patient Data
The U.S. Food and Drug Administration (FDA) announced a major policy shift to accept Real-World...
China Healthcare Fund Settlement Reform Targets 3% Ratio by 2028
The National Healthcare Security Administration (NHSA) released a notice to optimize healthcare fund settlement management,...