China’s NHSA Opens NRDL to AI and Digital Health Innovation, Unveils Scenario‑Driven Reimbursement Reform
The National Healthcare Security Administration (NHSA) issued a landmark notice this week to accelerate the...
Policy / Regulatory
Give Kids a Chance Act Extends FDA Pediatric Research Authority and PRV Program
The US Congress has introduced the Give Kids a Chance Act, legislation aimed at broadening...
Beijing Online Consultation Pilot Gets NHC Approval for Children’s Care
China’s National Health Commission (NHC) has approved the “Standardized Pilot Program for Online Initial Consultations...
NMPA Releases 101st Batch of Generic Reference Drugs
The National Medical Products Administration (NMPA) released the 101st batch of reference drugs for generic...
NHSA Targets NRDL Fund Supervision in 2026 Crackdown
China’s National Healthcare Security Administration (NHSA) this week issued the “Notice on Further Enhancing the...
FDA Opens PreCheck Applications to Strengthen Domestic Drug Manufacturing
The U.S. Food and Drug Administration this week began accepting applications for the FDA PreCheck...
CDE Seeks Feedback on 103rd Batch of Generic Reference Preparations
The Center for Drug Evaluation (CDE) is seeking industry feedback on the 103rd batch of...
FDA Removes Suicide Warnings from GLP‑1 Drugs After Investigation Finds No Causal Link
The U.S. Food and Drug Administration this month requested that Novo Nordisk and Eli Lilly...
China Drug Administration Implementation Regulations Set for May 2026 Launch
China’s State Council this week issued the Implementation Regulations of the Drug Administration Law, a...
NMPA Suspends Two Indian Pharma APIs Over GMP Violations
China’s National Medical Products Administration (NMPA) announced enforcement actions against two India‑based active pharmaceutical ingredient...
Merson’s Bemejing Wins First CNMR “Overseas Version” Drug Price Certificate
Beijing Merson Pharmaceutical Co., Ltd. announced that its Bemejing (timolol maleate gel) has obtained China’s...
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...
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...