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...
Policy / Regulatory
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,...
China Unveils Elderly Nursing Plan to Boost 90% Nurse Coverage by 2027
China’s National Health Commission (NHC), National Healthcare Security Administration (NHSA), National Administration of Traditional Chinese...
NHSA 2025 Drug Lists Add 114 Medical Insurance Drugs, 19 Commercial
The National Healthcare Security Administration (NHSA) released the 2025 National Medical Insurance Drug List and...
NHSA Guangzhou Drug-List Conference Releases 2025 Medical Insurance Formulary
The National Healthcare Security Administration (NHSA) announced it will host the 2025 Innovative Drugs High-Quality...
China Drug-Price Registration System Launches with First Batch of 10 Products
China’s Drug Price Registration System officially launched today with the first batch of 10 drug...
China Health: Life Expectancy Hits 79 Years as Hospitals Expand and Expenditure Controlled
The National Health Commission released the Statistical Bulletin on China’s Health Undertakings 2024, showing China’s...
CMS IRA Drug-Pricing Round 2 Delivers 62% Average Cut, Ozempic Falls 71%
The U.S. Centers for Medicare & Medicaid Services (CMS) announced results of the second round...
NMPA Issues Export Drug Certification Rules, Expanding Scope and Validity
China’s National Medical Products Administration (NMPA) released the “Regulations on Inspection and Export Certification Management...
FDA Pilot Program Offers Meeting Minute Clarification to Drug Sponsors
The U.S. Food and Drug Administration (FDA) announced a pilot program designed to streamline post‑meeting...
NMPA Releases 98th RLD Catalog for Chemical Generics, Adding 48 New Specifications
China’s National Medical Products Administration (NMPA) released the ninety-eighth batch of the Reference Listed Drugs...
Servier’s Vorasidenib Enters China’s SPARK Program – First Dual IDH Inhibitor for IDH‑Mutant Glioma
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) issued a...
FDA Issues Boxed Warning on Elevidys (delandistrogene moxeparvovec‑rokl) – Use Limited to Ambulatory DMD Patients Aged 4+
The U.S. Food and Drug Administration (FDA) announced a Boxed Warning for Elevidys, Sarepta Therapeutics’...
FDA Announces New ‘Plausible‑Mechanism’ Pathway to Rapid Approvals for Rare Disease Treatments
The U.S. Food and Drug Administration (FDA) announced on Wednesday a landmark regulatory shift that could...
NHSA Pilot AI Review Accelerates Full‑Process Medical Insurance Assessment in 7 Chinese Provinces
The National Healthcare Security Administration (NHSA) has announced a three‑phase, AI‑powered review pilot covering Beijing,...