China’s National Medical Products Administration (NMPA) has proposed draft measures to speed up reviews of cell and gene therapies. It is taking public comments for one month. The plan covers products for cancers, rare diseases, immune disorders, neurodegenerative conditions, and genetic disorders.... Read More
China’s healthcare insurance authority has completed its preliminary formal review for this year’s adjustments to the National Reimbursement Drug List and the Commercial Health Insurance Innovative Drug List. This moves the annual process forward toward final listing decisions later this year. The... Read More
China’s National Medical Products Administration (NMPA) has issued a new announcement that refines how medical devices and in vitro diagnostic (IVD) reagents are classified and managed when classification changes occur. Announcement No. 52 establishes new guidance for handling classification adjustments. It is... Read More
China has revised its Good Clinical Practice (GCP) regulations for drug clinical trials, introducing new requirements focused on quality management, participant protection, investigator accountability, and the use of innovative technologies. One major change is the adoption of a Quality by Design (QbD)... Read More
China’s revised Implementing Provisions of the Drug Administration Law took effect on May 15, 2026. This marks the first major update to the regulations in more than two decades. Most notably, the use of overseas clinical research data in drug registration applications... Read More
China’s National Medical Products Administration (NMPA) has released updated Good Manufacturing Practice (GMP) rules. The new rules introduce a revised quality management system (QMS) framework and will take effect on November 1, 2026. The regulation applies to both domestic and foreign manufacturers... Read More
Singapore’s Health Sciences Authority (HSA) and China’s National Medical Products Administration (NMPA) have renewed their regulatory cooperation agreement for health products, signing an updated Memorandum of Understanding (MOU) in Beijing on May 11, 2026. The revised agreement expands cooperation into newer areas,... Read More
China’s National Healthcare Security Administration (NHSA) has released the draft 2026 work plan for adjustments to the National Reimbursement Drug List (NRDL) and the Commercial Health Insurance Innovative Drug List (CHIDL), officially starting this year’s reimbursement review process. Several policy changes were... Read More
China is tightening oversight of its medical insurance system in 2026 through new rules and a nationwide anti-fraud campaign. The measures, introduced by the National Healthcare Security Administration (NHSA), took effect on April 1. This will increase scrutiny in every aspect of... Read More
China’s National Medical Products Administration (NMPA) has released six new guidelines to strengthen post-market surveillance and vigilance for medical devices. The updates set clearer expectations for quality management and require manufacturers and local agents (Marketing Authorization Holders) to have systems in place... Read More