FDA Issues Draft Guidance on Plausible Mechanism Framework – Accelerates Approval Pathway for Individualized Genetic Therapies
The U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the...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