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...
Policy / Regulatory
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,...
US FDA’s CNPV Fast‑Track Program Expands to 15 Drugs, Cutting Review Time to Months
The Commissioner’s National Priority Voucher (CNPV) pilot has just added 15 therapies to its two‑batch...
NHSA Concludes 2025 National Basic Medical Insurance Drug Catalogue Negotiation and Commercial Insurance Innovative Drug Price Talks
The National Healthcare Security Administration (NHSA) wrapped up a week‑long series of negotiations and bidding...
China CDE Opens Public Comment on 100th Batch of Reference Standards for Chemical Generic Drugs
The China Center for Drug Evaluation (CDE) has released a draft list of the 100th...
China’s National Health Commission Launches “Silver‑Haired” Healthcare & Elderly‑Care Initiative
The National Health Commission (NHC) has issued a formal notice to roll out the Silver‑Haired...
China’s National Health Commission Issues “AI + Healthcare” Implementation Opinions – Roadmap for 24 Standardized Applications
The National Health Commission (NHC) today released the Implementation Opinions on Promoting and Standardizing the...
Guangzhou’s 12‑Step Plan to Accelerate Innovative Drug and Device Adoption
The Guangzhou Municipal Health Commission issued a comprehensive notice detailing twelve strategic measures aimed at...
NHSA Re‑designs Drug‑Prescribing Surveillance, Targeting Illicit Use and Resale
The National Healthcare Security Administration issued a comprehensive notice to strengthen the intelligent monitoring of...
FDA Issues Draft Guidance to Accelerate Biosimilar Development and Cut Costs
The U.S. Food and Drug Administration (FDA) released a draft guidance titled “Scientific Considerations in...
FDA CDER Director George Tidmarsh Placed on Leave Amid Probe Over Drug‑Approval Program Concerns
The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) confirmed that...