NMPA Releases 85th Batch of Reference Drugs for Generic Quality Consistency Evaluation
The National Medical Products Administration (NMPA) has released the 85th batch of reference drugs for...
NMPA
China’s NHC Launches Pilot Plan to Expand Wholly Foreign-Owned Hospital Sector
The National Health Commission (NHC) has released the “Pilot Work Plan for Expanding the Wholly...
NMPA Drafts Medical Representative Management Measures, Seeks Public Input
The National Medical Products Administration (NMPA) has released the “Medical Representative Management Measures (draft proposal)”,...
Chinese Pharmacopoeia Commission Approves Draft for ChP 2025 Edition
On December 27, the 12th Conference of the Chinese Pharmacopoeia Commission (ChPC) Executive Committee concluded...
NMPA and Local Governments Streamline Drug Approval Processes in China
The National Medical Products Administration (NMPA) has released a notification regarding the pilot work for...
CDE Includes Double-Crane’s Hydroxocobalamine and Sanofi Genzyme’s Fitusiran in Rare Disease Care Plan
China’s Center for Drug Evaluation (CDE) has announced the inclusion of China Resources Double-Crane Pharmaceutical...
NMPA’s CDE Issues Guidelines for Leveraging Real-World Data in Drug Regulation
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released...
NMPA Issues Interim Provisions for Overseas MAHs’ Designated Domestic Responsible Persons
The National Medical Products Administration (NMPA) has released the “Interim Provisions on the Management of...
NMPA Draft Proposal Aims to Strengthen Supervision of Drug Entrusted Manufacturing
The National Medical Products Administration (NMPA) has released a draft proposal titled “Announcement on Strengthening...
China’s NMPA Issues Guidelines for Domestic Manufacturing of Imported Medical Devices
The National Medical Products Administration (NMPA) has released a notification aimed at further clarifying the...
NMPA Releases 84th Batch of Reference Drugs for GQCE and First Batch Stripped of Status
The National Medical Products Administration (NMPA) has released the 84th batch of reference drugs for...
China’s NMPA and Denmark’s Medicines Agency Commit to Enhanced Regulatory Cooperation
The National Medical Products Administration (NMPA) of China and the Danish Medicines Agency have signed...
China’s NMPA Launches Pilot Program for Phased Manufacturing of Biological Products
The National Medical Products Administration (NMPA) has officially released the “Pilot Work Plan for Phased...
China’s NMPA Greenlights Pilot Plan for Phased Manufacturing of Biological Products
The National Medical Products Administration (NMPA) has given its stamp of approval to the “Pilot...
NMPA Sets Forthcoming Guidelines for Domestic Drug Refiling Procedures
The National Medical Products Administration (NMPA) has issued a notification outlining the requirements for the...
China’s NMPA Proposes Rewards for Internal Whistleblowers in Drug and Medical Device Safety Reporting
The National Medical Products Administration (NMPA) of China has issued a draft proposal for the...
NMPA Expands Generic Quality Consistency Evaluation with 83rd Batch of Reference Drugs
The National Medical Products Administration (NMPA) in China has announced the release of the 83rd...
China Unveils Medical Insurance Eligibility Management System for Designated Healthcare Personnel
The National Healthcare Security Administration (NHSA), National Health Commission, and National Medical Products Administration (NMPA)...
China’s NMPA Releases Standards for Brain-Computer Interface Medical Devices
The National Medical Products Administration (NMPA) in China has issued a notification confirming the establishment...
GSK’s Blenrep-BorDex Combo Earns Breakthrough Therapy Designation in China for Multiple Myeloma
The UK-based pharmaceutical colossus, GSK (LON: GSK, NYSE: GSK), has secured a Breakthrough Therapy Designation...