NHSA Completes 2025 Drug Negotiation Review; CAR‑T Therapies Clear the Hurdle
The National Healthcare Security Administration (NHSA) announced today that the expert review for the 2025...
Policy / Regulatory
China CDE Seeks Public Feedback on 98th Batch of Reference Standards for Generic Drugs
The China Center for Drug Evaluation (CDE) has published a draft list of the 98th...
Guangdong Launches 5‑Year Plan to Streamline Import of Urgently Needed Drugs and Medical Devices
The Guangdong Provincial Drug Administration and the Guangdong Provincial Health Commission jointly announced the “Administrative...
NMPA Releases 96th Reference Listed Drugs Catalog, Adding 42 New Generic Specifications
The National Medical Products Administration (NMPA) has just published the 96th edition of its Reference...
FDA Launches Aggressive Campaign to Curb Misleading Drug Advertisements
The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration...
NMPA Unveils 30‑Working‑Day Pathway to Accelerate Innovative Drug Trials
The National Medical Products Administration (NMPA) announced a new regulatory framework—Announcement No. 86 of 2025—that promises to...
China to Add HPV Vaccine to National Immunization Program, Pledges Free Shots for Eligible Girls
At a State Council Information Office press conference, Deputy Director of the National Health Commission...
China’s Drug Evaluation Authority Issues Draft Rules for Class I ATMP Meetings
The Center for Drug Evaluation (CDE), part of China’s National Medical Products Administration (NMPA), published...
China Unveils “Healthcare Foundation Strengthening Plan” to Bring Clinics Within 15‑Minute Reach
The State Council released the Implementation Plan for the Healthcare Foundation Strengthening Project, setting a...
NMPA Releases Online Prescription Compliance Guidelines to Tighten Drug Retail Oversight
The National Medical Products Administration (NMPA) issued a draft of its Compliance Guidelines for Online...
FDA Launches “Green List” to Shield U.S. Markets from Unsafe GLP‑1 APIs
The U.S. Food and Drug Administration (FDA) today announced a new “green list” import alert...
NHSA Releases Draft Regulations to Tighten Medical Insurance Funds Oversight
On September 7, 2025, China’s National Healthcare Security Administration (NHSA) issued the Draft Implementation Rules for the...
FDA Unveils RDEP to Accelerate Rare Disease Therapy Development
The U.S. Food and Drug Administration (FDA) today issued the Rare Disease Evidence Principles (RDEP),...
NMPA Adds 35 New Reference‑Listed Drugs to 95th Catalog, Updates 31 Existing Specs
The National Medical Products Administration (NMPA) today announced the release of its 95th Reference‑Listed Drugs...
NHSA 2025 Drug Catalog Review: 6 Drugs Rejected, 718 Applications Reviewed
The National Healthcare Security Administration (NHSA) on Aug. 28, 2025 announced the formal review outcomes...
China’s NMPA Resumes Import of Vasudha’s Loratadine API After Rectifications
China’s National Medical Products Administration (NMPA) announced on August 20, 2025, that it had resumed...
InnoCare Pharma’s ICP-723 Joins China’s SPARK Project for Pediatric Solid Tumors
China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) has announced...
China Releases Draft Guidelines for Single-Arm Oncology Trials to Support Drug Approvals
On August 20, 2025, the Center for Drug Evaluation (CDE) of the National Medical Products...
China Unveils Ten Measures to Boost Family Doctor Contract Services
In a significant move to enhance the quality and accessibility of primary healthcare, the National...
China’s NHSA Releases Interim Measures for Medical Case-Based Payment Management
The National Healthcare Security Administration (NHSA) issued the “Interim Measures for Medical Security Case-Based Payment...