Beijing Aims to Establish Rare Disease Drug Security Pilot Zone with ‘White List’ System
Beijing is set to follow in the footsteps of Boao Lecheng with the release of...
Policy / Regulatory
Beijing Authorities Release Negative List for Data Export in Key Industries
Authorities in Beijing, including the Beijing Municipal Bureau of Commerce and the Beijing Municipal Service...
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...
NHSA Concludes 2024 NRDL Review, Announces Submission Deadlines for Drug Manufacturers
The National Healthcare Security Administration (NHSA) has declared the completion of the expert review process...
China Boosts Public Health Subsidies and Targets Weight Management in 2024
The National Health Commission, Ministry of Finance, National Administration of Traditional Chinese Medicine, and National...
China’s NHSA and MOF Issue Notices to Enhance Cross-Regional Medical Treatment Direct Settlement
The National Healthcare Security Administration (NHSA) and the Ministry of Finance (MOF) have issued two...
CDE Launches CARE Plan to Streamline Rare Disease Drug Development
The Center for Drug Evaluation has unveiled the ‘Pilot Work Plan for Patient-Centered Action for...
South Korea’s MFDS Aims to Slash Drug Approval Times with New Innovation Plan
South Korea’s Ministry of Food and Drug Safety (MFDS) has unveiled an ambitious plan to...
FDA Uncovers Data Management Failures in Medical Device Labs, Assessing Regulatory Impact
Medical device manufacturers relying on laboratory services for testing and validation data have come under...
China Aims to Fortify Insurance Industry by 2035 with New State Council Directives
The State Council has issued the “Several Opinions on Strengthening Supervision, Preventing Risks, and Promoting...
NHC Releases Updated List of Pediatric Drugs for Research and Development Incentives
The National Health Commission (NHC) has issued a notification regarding the fifth batch of pediatric...
China’s CDE Issues Draft Guidelines for Biosimilar Pharmaceutical Similarity Research
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released...
China’s 2024 Negative List Eases Restrictions on Foreign Investment in TCM and Biotechnology
The National Development and Reform Commission (NDRC) of China has announced the release of the...
China’s NMPA Proposes Inclusion of Cochlear Implants in Volume-Based Procurement Plans
The National Medical Products Administration (NMPA) has disclosed plans to expand the scope of its...
China’s NHSA Proposes New Guidelines to Enhance Oversight of Medical Insurance Funds
The National Healthcare Security Administration (NHSA) has unveiled a draft of the “Guiding Opinions on...
China Opens Doors to Foreign Biotech and Wholly-Owned Hospitals in Healthcare Sector Expansion
China’s Ministry of Commerce, National Health Commission, and National Medical Products Administration (NMPA) have jointly...
Guangzhou Health Commission Unveils Ten Measures to Boost Innovative Pharma and Medical Device Development
On September 5, 2024, the Guangzhou Health Commission issued the “Guangzhou Health Commission’s Ten Measures...
Biosecure Act Faces Opposition from Senior House Democrat Jim McGovern
The trajectory of the US Biosecure Act through the House of Representatives encountered unexpected turbulence...
China’s CDE Releases 86th Batch of Reference Preparations for Generic Drug Evaluation
China’s Center for Drug Evaluation (CDE) has unveiled its 86th roster of reference preparations for...
U.S. House of Representatives to Review the Biosecure Act Amid Legislative Hurdles
The U.S. House of Representatives is slated to take up the contentious Biosecure Act the...