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...
Policy / Regulatory
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...
China Issues Guidelines for Medical Advertisement Identification, Clarifies Scenarios and Regulations
The State Administration for Market Regulation (SAMR), in collaboration with the National Health Commission (NHC)...
FDA Launches PreCheck Program to Strengthen U.S. Pharmaceutical Supply Chain
The U.S. Food and Drug Administration (FDA) announced the launch of “FDA PreCheck” on August...
China’s NHSA Publishes Preliminary List for 2025 National Reimbursement Drug List and Commercial Insurance Innovative Drug List
China’s National Healthcare Security Administration (NHSA) released the preliminary formal review results for the 2025...
Macao Drug Administration Expands White List for Designated Medical Institutions in Cooperation Zone
The Drug Administration of the Macao Special Administrative Region (SAR) of China has announced the...
NHSA Updates Volume-Based Procurement Policy for Medical Institutions in 11th VBP Tender
The National Healthcare Security Administration (NHSA) has released Q&As on the medical institutions’ volumes filing...
Shanghai Issues New Measures to Boost Commercial Health Insurance for Biopharmaceutical Innovation
On August 6, 2025, seven Shanghai-based authorities jointly issued a notice titled “Several Measures on...
FDA Mandates Safety Labeling Changes for Opioid Pain Medications and Targets 7-OH Products
The U.S. Food and Drug Administration (FDA) is implementing new safety measures for opioid pain...