China’s CDE Releases 107th Batch of Reference Preparations for Generic Drug Consistency Evaluation with 17 New Drugs Added
China’s Center for Drug Evaluation (CDE) has published the 107th batch of reference preparations for...
Policy / Regulatory
PKU Hi-Tech Huatai Pharmaceuticals Blacklisted from China’s Volume-Based Procurement Following Quality Compliance Failures
PKU Hi-Tech Huatai Pharmaceuticals Co., Ltd. has been blacklisted from China’s national volume-based procurement (VBP)...
China’s Four Health Regulators Issue Revised Good Clinical Practice Guidelines Effective September 2026, Strengthening Trial Oversight and Ethical Standards
China’s National Medical Products Administration (NMPA), National Health Commission (NHC), National Administration of Traditional Chinese...
China’s National Health Commission Launches Anti-Corruption Campaign Targeting Pharmaceutical Sales and Healthcare Services Misconduct
China’s National Health Commission (NHC) released the “Notice on Key Points for Rectifying Misconduct in...
China’s NHC Releases Sixth Pediatric Drug Priority List – 27 Varieties Including Emicizumab, Pembrolizumab, and Omalizumab Targeted for Development
China’s National Healthcare Commission (NHC) announced the release of its sixth batch of pediatric drugs...
FDA Issues Draft Guidance to Accelerate Gene Therapy Development Through Platform Knowledge Sharing
The U.S. Food and Drug Administration (FDA) released draft guidance on June 2, 2026, designed...
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The U.S. Food and Drug Administration (FDA) released draft guidance aimed at reducing unnecessary animal...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...