China’s CDE Issues Draft Guidelines for Overseas Drug Market Approval Filings
China’s Center for Drug Evaluation (CDE) has unveiled a draft set of “Application Material Requirements”...
Policy / Regulatory
China Announces New Hospital Inspection Measures to Standardize Healthcare System
The National Health Commission (NHC), in collaboration with the National Administration of Traditional Chinese Medicine...
China Releases Emergency Use Rules for Medical Devices Amid Public Health Emergencies
The National Medical Products Administration (NMPA), National Health Commission (NHC), and Chinese Center for Disease...
Jiangsu Initiates Sunshine Procurement Round for Medical Consumables with 46 Products
The Jiangsu Public Resource Trading Platform has announced a new round of sunshine online procurement...
China’s 2023 NRDL Expands Coverage with 126 New Drugs, Aims for Savings and Accessibility
The National Healthcare Security Administration (NHSA) has released the finalized National Reimbursement Drug List (NRDL)...
Hong Kong Aims for “First-Level Approvals” with New Drug Regulatory Institution
Hong Kong is taking steps to establish a drug regulatory institution that will permit “first-level...
CDE Requests Feedback on 77th Batch of Chemical Generic Reference Preparations by December 20
The Center for Drug Evaluation (CDE) is currently soliciting feedback on the 77th batch of...
FDA Investigates Safety of China-Made Plastic Syringes Due to Quality Concerns
The US Food and Drug Administration (FDA) has issued a warning that it is investigating...
China’s State Council Unveils Comprehensive Plan to Boost Beijing’s Healthcare Sector
The State Council has unveiled a comprehensive “Work Plan” aimed at enhancing Beijing’s service industry...
China’s CDE Expands Market Approval Services with Two New Regional Windows
The China Center for Drug Evaluation (CDE) has announced the establishment of two additional external...
NMPA Approves TINGSN Technology’s Disposable Intracardiac Ultrasound Diagnostic Catheter
The National Medical Products Administration (NMPA) has granted market approval to TINGSN Technology, a China-based...
CAR T-Cell Therapy Stocks Plunge as FDA Investigates Cancer Reports Linked to Treatments
Shares of Chimeric Antigen Receptor (CAR) T cell therapy companies plummeted on November 28, 2023,...
China’s Pharma Distribution Market Grows Steadily in 2022, Driven by Retail Sales Surge
The Ministry of Commerce (MofCOM) has released its annual statistical review of China’s pharmaceutical distribution...
China’s NHSA Issues Guidelines to Strengthen Medical Pricing and Procurement Credit Ratings
The National Healthcare Security Administration (NHSA) has issued a notification concerning medical pricing and tendering...
China’s CDE Releases Draft Guidelines for Decentralized Trials in Rare Disease Drug Development
China’s Center for Drug Evaluation (CDE) has released draft “Technical Guidelines for the Application of...
European Commission Proposes Overhaul of Pharmaceutical Legislation
The European Commission (EC) is advancing an update to Europe’s 20-year-old pharmaceutical legislation, with the...
National Reimbursement Drug List Negotiations and Bidding Process Conclude
The on-site negotiation and bidding processes for the 2023 update to China’s National Reimbursement Drug...
Final Results of China’s Round 9 Volume-Based Procurement Tender Announced
The National Allied Procurement Office has released the finalized results and tender bid allocations for...
CDE Releases 76th Batch of Chemical Generic Reference Preparations
The Center for Drug Evaluation (CDE) has released the 76th batch of chemical generic reference...
China’s National Allied Procurement Office Announces VBP Tender for Medical Consumables and 3D Printing Products
The National Allied Procurement Office has released a notification outlining plans for a volume-based procurement...