China’s CDE Opens Public Comment on “Pioneer Program” for Cell and Gene Therapy Products, Capping Intake at 15 Drugs Per Year
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released work...
Policy / Regulatory
FDA Issues Discussion Paper on GenAI‑Enabled Medical Devices – Seeks Feedback on Risk Framework, Premarket Evaluation and Postmarket Monitoring by October 19
The U.S. Food and Drug Administration (FDA) issued a discussion paper on considerations for the...
Trump Picks White House Policy Advisor Heidi Overton to Lead FDA – Replacing Acting Commissioner Kyle Diamantas After Makary’s Resignation
U.S. President Donald Trump has chosen White House policy advisor Heidi Overton to lead the...
Guangdong Regulator Issues Recall, Traceability and Emergency Response Rules for Imported Hong Kong–Macao Pharmaceuticals and Medical Devices in GBA
The Guangdong Medical Products Administration issued three landmark policy documents governing imported Hong Kong and...
NMPA Releases Draft Implementation Rules for the National Key R&D Program – Public Comment Open Through 12 Sept 2026
China’s National Medical Products Administration (NMPA) has released for public comment the “Implementation Rules for...
China’s CDE Releases 109th Reference Listed Drug Catalog, Adding 10 New Generic Drug Specifications
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the...
NMPA Proposes Framework for Synchronized Development of Anti-Tumor Drugs and Companion Diagnostics
China’s National Medical Products Administration (NMPA) announced that the Center for Medical Device Evaluation and...
NMPA Releases 107th Batch of Reference Drugs for Generic Quality Consistency Evaluation, Adding 71 New Specifications
China’s National Medical Products Administration (NMPA) announced the release of its 107th batch of reference...
China’s 12th National Drug Volume-Based Procurement Yields Preliminary Winners with Originator Drugs Securing Key Positions
China’s National Joint Procurement Office (NJPO) announced preliminary results for the 12th batch of national...
China’s CDE Tightens Drug Review Standards with New “No Supplemental Data” Rule for Major Deficiencies
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released a...
China’s NMPA Proposes Sweeping Reforms to Medical Device E-Commerce with New Draft Regulations
China’s National Medical Products Administration (NMPA) released the Administrative Measures for Medical Device Online Sales...
China’s 12th National Drug Procurement Round Attracts 500+ Companies, Targets 7.34 Billion Units
China’s National Drug Joint Procurement Office released enterprise-related information for the 12th batch of national...
Trump Announces Phased Tariff Policy on Generic Drug Imports to Incentivize U.S. Manufacturing Reshoring
Former President Donald Trump announced on July 21, 2026 a three-phase tariff policy on generic...
Guangdong Launches Greater Bay Area Cross-Border Medical Import Framework for Hong Kong and Macau Pharmaceuticals
The Guangdong Provincial Drug Administration and Guangdong Provincial Health Commission have issued the Guidelines for...
China Announces 12th National Drug Volume-Based Procurement with Enhanced Pricing Mechanism and Expanded Participation
The National Joint Procurement Office announced on July 22, 2026 that the 12th batch of...
China Launches 12th Batch of National Drug Procurement with Vonoprazan and Vitamin B6 Drawing Record Competition
The National Joint Procurement Office (NJPO) has issued the Notice on Corporate Affiliations for the...
Fujian Province Launches Comprehensive Biomedical Innovation Support Framework with Accelerated Listing, Premium Pricing, and Enhanced Insurance Coverage Mechanisms
The Fujian Provincial Medical Security Bureau has implemented the “Ten Measures to Support the Innovative...
China’s NMPA Suspends Medochemie’s Tramadol Hydrochloride Capsules Following Non-Compliant Overseas Inspection and Documentation Failure
China’s National Medical Products Administration (NMPA) announced the immediate suspension of import, sale, and use...
China’s Health Authorities Issue Comprehensive Medical Equipment Centralized Procurement Framework with Tiered Implementation and High-Value Equipment Database
The National Health Commission (NHC), National Administration of Traditional Chinese Medicine (NATCM), and National Disease...
China’s CDE Releases Draft Guideline for Real-World Evidence-Based Pediatric Indication Expansion of Marketed Drugs
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) issued the...