FDA Issues Draft Guidance to Accelerate Gene Therapy Development Through Platform Knowledge Sharing
The U.S. Food and Drug Administration (FDA) released draft guidance on June 2, 2026, designed...
Policy / Regulatory
China’s National Health Commission Unveils Ambitious Plan for Community Health Service Expansion by 2030
China’s National Health Commission (NHC) has released the “Notice on Further Improving the Urban Community...
China’s NMPA Introduces Comprehensive Medical Device Classification Reforms with 2-5 Year Transitional Periods
China’s National Medical Products Administration (NMPA) released two landmark regulatory announcements this week: the “Announcement...
NMPA Opens 2026 National Reimbursement Drug List Application Window with Revised Eligibility Criteria and Price Controls
China’s National Medical Products Administration (NMPA) has released the “2026 Adjustment Work Plan for the...
FDA Proposes Streamlined Animal Testing Requirements for Oncology Drugs to Accelerate Development Timeline
The U.S. Food and Drug Administration (FDA) released draft guidance aimed at reducing unnecessary animal...
China’s NHSA Proposes First National Basic Medical Insurance Medical Service Items List to Standardize Reimbursement Framework
China’s National Healthcare Security Administration (NHSA) has released a draft proposal titled “Work Plan for...
NMPA Issues Comprehensive Guidelines for Online Prescription Drug Retail, Mandating Human Pharmacist Review and AI Prescription Blocking
China’s National Medical Products Administration (NMPA) has released the “Compliance Guidelines for Online Retail of...
China Tightens Medical Insurance Personal Account Oversight with Mandatory “White List” for Retail Pharmacy Purchases
China’s National Healthcare Security Administration (NHSA) and Ministry of Finance jointly issued a comprehensive notice...
China Issues National Guidelines for Home Hospital Bed Services to Address Healthcare Access for Vulnerable Populations
China’s National Health Commission (NHC) and the National Administration of Traditional Chinese Medicine (NATCM) issued...
China’s CDE Reports Record Drug Review Activity in 2025 – Breakthrough Therapy Designations Surge 11% as Regulatory Filings Hit 20,149
China’s Center for Drug Evaluation (CDE) released its 2025 Annual Drug Review Report, revealing record...
China’s NHSA Unveils Five-Year Medical Insurance Fund Supervision Plan (2026–2030) – AI-Powered Oversight to Combat Fraud Across Healthcare Ecosystem
China’s National Healthcare Security Administration (NHSA) released its comprehensive “Five-Year Action Plan for Medical Insurance...
Hong Kong to Launch FDA-Style Medical Products Regulation Center by Year-End, Creating Gateway for Chinese Innovative Drugs
Hong Kong’s Centre for Medical Products Regulation (CMPR) is set to be established by the...
NMPA Releases 105th Batch of Generic Drug Reference Standards, Adding 37 New Specifications
China’s National Medical Products Administration (NMPA) announced the release of the 105th batch of reference...
NHSA Launches 2026 NRDL Adjustment with Expanded Eligibility Criteria and Revised Weight Standards
The National Healthcare Security Administration (NHSA) has released its draft 2026 Work Plan for Adjusting...
China’s National Drug Alliance Procurement Office Suspends Harbin Liqiang’s Loxoprofen Gel Patch Production and Imposes 18-Month VBP Ban
The National Drug Alliance Procurement Office, administrator of China’s volume-based procurement (VBP) program, announced the...
China’s Seven Ministries Issue Revised Pharmaceutical Representative Management Measures to Combat Commercial Bribery and Strengthen Industry Oversight
China’s National Medical Products Administration (NMPA), in coordination with six other regulatory bodies, has jointly...
China’s NHC Unveils 16-Point Pediatric Medicines Reform to Strengthen Supply Security and Clinical Access
China’s National Health Commission (NHC) released comprehensive “Implementation Opinions on Reforming and Improving the Supply...
China Elevates Pediatric Healthcare Infrastructure – NHC Expands National Children’s Medical Center Network to 14 Facilities
China’s National Health Commission (NHC) announced a significant expansion of the country’s pediatric healthcare infrastructure,...
China’s NHC Establishes Regulatory Framework for Biomedical New Technologies with Interim Guiding Principles Effective May 1, 2026
The National Health Commission (NHC) of China has implemented the Guiding Principles for Defining Biomedical...
NMPA Tightens Post-Marketing Requirements for Conditionally Approved Drugs in China, Mandating Four-Year Confirmatory Studies and Annual Progress Reporting
China’s National Medical Products Administration (NMPA) has issued a new regulatory framework clarifying post-approval obligations...