China Imposes Historic Four-Year VBP Ban on Fu Kang Ren, Hetero Labs for Supply Failures; Hehe and Tiantaishan Also Penalized
The National Drug Alliance Procurement Office has revoked the Volume-Based Procurement (VBP) winning bid qualifications...
Policy / Regulatory
China’s CDE Releases 105th Batch of Reference Preparations for Generic Drug Evaluation, Adds 8 New Drugs
China’s Center for Drug Evaluation (CDE) has published the 105th batch of reference preparations for...
NMPA Finalizes Conditional Drug Approval Framework to Accelerate Access to Critical Medicines
China’s National Medical Products Administration (NMPA) has announced the review and approval of the “Working...
NMPA Expands Generic Quality Consistency Evaluation Program with 36 New Reference Drug Specifications
China’s National Medical Products Administration (NMPA) has released its 103rd batch of reference drugs for...
China State Council Mandates Long-Term Care Insurance System – 0.3% Contribution Rate Targets Severe Disability Coverage Within Three Years
China’s State Council issued “Opinions on Accelerating the Establishment of a Long-Term Care Insurance System”,...
China NHC Elevates Chikungunya and SFTS to Category B Status – Enhanced Surveillance and Control Measures Effective April 2026
China’s National Health Commission (NHC) announced that chikungunya fever and severe fever with thrombocytopenia syndrome...
NHSA Unveils DRG 3.0 Grouping Scheme Roadmap – Systematic Upgrade Targets 2027 Implementation
China’s National Healthcare Security Administration (NHSA) held a briefing outlining the DRG (Diagnosis‑Related Groups) Grouping...
China NHC Issues Medical Technology Evaluation Procedures – New Framework Triggers Restrictions or Bans on Controversial Clinical Practices
China’s National Health Commission (NHC) issued the “Work Procedures for Evaluating the Clinical Application of...
FDA Releases Draft Guidance on NAMs – Accelerating Shift from Animal Testing to Human‑Relevant Drug Safety Assessment
The US Food and Drug Administration (FDA) has advanced its “Roadmap to Reducing Animal Testing...
China Unveils NHSA Grassroots Healthcare Reform – 14‑Point Guidance Targets RMB Fund Flow Shift to Primary Care Institutions
China’s National Healthcare Security Administration (NHSA), jointly with the National Development and Reform Commission and...
Ascentage Pharma and Haisco Secure CDE SPARK Inclusion for Pediatric Oncology Candidates – APG‑115 and HSK42360 Target High‑Unmet‑Need Childhood Cancers
China’s Center for Drug Evaluation (CDE) has selected two innovative oncology assets for its Support...
China’s Basic Medical Insurance Covers 1.33 Billion in 2025 – NHSA Reports RMB 3.6 Trillion Fund Inflows, 114 New Drugs Added to NRDL
China’s National Healthcare Security Administration (NHSA) released its 2025 Healthcare Security Development Statistical Bulletin, revealing...
FDA Streamlines Biosimilar Development – New Guidance Cuts PK Study Costs by 50%, Accelerates Path to Market
The U.S. Food and Drug Administration (FDA) announced a major policy shift to accelerate biosimilar...
FDA Advances Section 804 Drug Importation Program – States Meet Agency on Canadian Prescription Import Pathway
The U.S. Food and Drug Administration (FDA) convened meetings with multiple states this week to...
NMPA Removes OCALIVA from GQCE Reference List – Obeticholic Acid Stripped Over Safety Concerns, Benefit-Risk Profile
China’s National Medical Products Administration (NMPA) released the 102nd batch of reference drugs for generic...
China’s 2026 Government Work Report Unveils Healthcare Overhaul – VBP Optimization, TCM Innovation, and 300M Long‑Term Care Expansion
The State Council released its 2026 Government Work Report, outlining a comprehensive healthcare transformation agenda...
NMPA CDE Launches “Caring Program – Extension” Pilot – Accelerates Rare Disease Drug Development Pathway
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) released the...
NMPA Approves 76 Innovative Medical Devices in 2025 – 17% YoY Growth Driven by AI and Priority Review Surge
The National Medical Products Administration (NMPA) released its 2025 Annual Medical Device Registration Report, highlighting...
NMPA CDE Opens Public Consultation for 104th Reference Listed Drugs Catalog – 63 Specifications Under Review
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) officially opened...