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...
Policy / Regulatory
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FDA Issues Draft Guidance on Plausible Mechanism Framework – Accelerates Approval Pathway for Individualized Genetic Therapies
The U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the...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...
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...