GuangDong Pharmaceutical Association Releases Updated Off-Label Drug List for 2023
The GuangDong Pharmaceutical Association has released the 2023 version of its off-label drug list, marking...
Policy / Regulatory
Shanghai’s SMPA Reduces Ceiling Price for Non-Winning Bids in Artificial Joint VBP Tender
Shanghai’s Sunshine Medical Procurement All-in-One (SMPA) has issued a notification regarding an artificial joint volume-based...
National Health Commission’s Anti-Corruption Drive Impacts China’s Pharmaceutical Sector
An anti-corruption crackdown announced by the National Health Commission (NHC) at the end of July...
Shanghai HSA Unveils Measures to Boost Access to Innovative Drugs and Devices
The Healthcare Security Administration (HSA) in Shanghai has recently released a set of Measures aimed...
CDE Releases Draft Guidelines for Clinical Pharmacology Research of Chemical Modified Drugs
The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Clinical Pharmacological Research...
NMPA Seeks Public Input on Strengthening Supervision of Medical Device Contract Manufacturing
The National Medical Products Administration (NMPA) is currently seeking public feedback on the “Opinions on...
China’s NHC Launches Trial Specifications for Clinical Decision Support Systems in Hospitals
The National Health Commission (NHC) has issued a set of specifications for the application and...
NHSA Issues 2023 Guidelines: Enhancing Basic Medical Insurance and Major Illness Coverage
The National Healthcare Security Administration (NHSA) has released the “Notice on Ensuring Basic Healthcare Security...
CDE Issues Guiding Principles for Natural History Research in Rare Disease Drug Development
The Center for Drug Evaluation (CDE) has released the “Guiding Principles for Natural History Research...
CDE Launches Technical Guidelines to Emphasize Patient-Centered Drug Clinical Trials
The Center for Drug Evaluation (CDE) has released a series of Technical Guidelines that encompass...
Pingshan District and Fosun Pharma Ink Strategic Deal to Boost Biomedical Industry
The People’s Government of Pingshan District in Shenzhen has signed a cooperation framework agreement with...
EU Commits EUR 3 Million to Strengthen Healthcare Access in Latin America and Caribbean
The European Union (EU) has announced a EUR 3 million (USD 3.3 million) funding injection...
Taiwan’s TFDA Orders Recall of Two Nucala Batches Due to Glass Fragments
The Food and Drug Administration (FDA) bureau of Taiwan, part of Greater China, has issued...
NMPA Updates List of Medical Devices Exempt from Clinical Evaluation in China
The National Medical Products Administration (NMPA) has released an updated version of the “List of...
Chinese Health Authorities Unveil Key Reform Tasks for Medical System in H2 2023
The National Health Commission (NHC), National Development and Reform Commission (NDRC), Ministry of Finance (MoF),...
NHSA Releases Official Guidelines for Drug Negotiations and Bidding for NRDL Update
The National Healthcare Security Administration (NHSA) has officially released the “Negotiation Drug Renewals” and “Non-exclusive...
National Health Commission Launches One-Year Anti-Corruption Campaign in Pharmaceutical Sector
The emergency response department of the National Health Commission (NHC) has released a notification signaling...
Johnson & Johnson Files Lawsuit Against US Government’s Drug Pricing Negotiation Authority
United States-based Johnson & Johnson (J&J, NYSE: JNJ) has filed a lawsuit this week, challenging...
US Merger Guidelines Updated: Public Comment Sought on Antitrust Law Changes
The United States has published an update to its merger and acquisition guidelines, seeking public...
NMPA Releases 70th Batch of Reference Drugs for Generic Quality Consistency Evaluation
The National Medical Products Administration (NMPA) has released the 70th batch of reference drugs for...