FDA Releases Draft Guidance on NAMs – Accelerating Shift from Animal Testing to Human‑Relevant Drug Safety Assessment
The US Food and Drug Administration (FDA) has advanced its “Roadmap to Reducing Animal Testing...
Policy / Regulatory
China Unveils NHSA Grassroots Healthcare Reform – 14‑Point Guidance Targets RMB Fund Flow Shift to Primary Care Institutions
China’s National Healthcare Security Administration (NHSA), jointly with the National Development and Reform Commission and...
Ascentage Pharma and Haisco Secure CDE SPARK Inclusion for Pediatric Oncology Candidates – APG‑115 and HSK42360 Target High‑Unmet‑Need Childhood Cancers
China’s Center for Drug Evaluation (CDE) has selected two innovative oncology assets for its Support...
China’s Basic Medical Insurance Covers 1.33 Billion in 2025 – NHSA Reports RMB 3.6 Trillion Fund Inflows, 114 New Drugs Added to NRDL
China’s National Healthcare Security Administration (NHSA) released its 2025 Healthcare Security Development Statistical Bulletin, revealing...
FDA Streamlines Biosimilar Development – New Guidance Cuts PK Study Costs by 50%, Accelerates Path to Market
The U.S. Food and Drug Administration (FDA) announced a major policy shift to accelerate biosimilar...
FDA Advances Section 804 Drug Importation Program – States Meet Agency on Canadian Prescription Import Pathway
The U.S. Food and Drug Administration (FDA) convened meetings with multiple states this week to...
NMPA Removes OCALIVA from GQCE Reference List – Obeticholic Acid Stripped Over Safety Concerns, Benefit-Risk Profile
China’s National Medical Products Administration (NMPA) released the 102nd batch of reference drugs for generic...
China’s 2026 Government Work Report Unveils Healthcare Overhaul – VBP Optimization, TCM Innovation, and 300M Long‑Term Care Expansion
The State Council released its 2026 Government Work Report, outlining a comprehensive healthcare transformation agenda...
NMPA CDE Launches “Caring Program – Extension” Pilot – Accelerates Rare Disease Drug Development Pathway
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the...
NMPA Approves 76 Innovative Medical Devices in 2025 – 17% YoY Growth Driven by AI and Priority Review Surge
The National Medical Products Administration (NMPA) released its 2025 Annual Medical Device Registration Report, highlighting...
NMPA CDE Opens Public Consultation for 104th Reference Listed Drugs Catalog – 63 Specifications Under Review
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) officially opened...
FDA Issues Draft Guidance on Plausible Mechanism Framework – Accelerates Approval Pathway for Individualized Genetic Therapies
The U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the...
FDA Cracks Down on Compounded GLP-1 APIs; Novo Nordisk Sues Hims & Hers for Patent Infringement
The U.S. Food and Drug Administration (FDA) announced decisive regulatory action to restrict GLP-1 active...
China’s NHSA Launches Reference Drug Pre-Communication System to Streamline Reimbursement Pathway
The National Healthcare Security Administration (NHSA) has released the “Reference Drugs Pre-communication Measures (Trial)”, establishing...
Guangdong Unveils Expanded 2025 Greater Bay Area Access List for 115 Hong Kong and Macao Drugs and Devices
The Medical Products Administration of Guangdong Province (GDMPA) and Health Commission of Guangdong Province (GDHC)...
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...
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...