China’s 11th round of national Volume-Based Procurement (VBP) came to an end in late October 2025 with all 55 tendered drug products awarded contracts across major therapeutic areas such as anti-infectives, oncology, diabetes, cardiovascular disease, lipid disorders, pain management, and allergy treatment.... Read More
China has strengthened its regulation of excessive prescription practices through a new National Healthcare Security Administration (NHSA) notice issued on November 3, 2025, alongside the nationwide Insurance Fraud “Hundred-Day Campaign.” The measure aims to crack down on fraud, abuse, and improper use of medical... Read More
China’s National Medical Products Administration (NMPA) has published the draft Good Clinical Practice for Drugs (2025) with fundamental changes to further enhance participant protection, data integrity, and trial quality. Published at the end of October, 2025, this draft condenses the current eight-chapter... Read More
On November 4, the National Medical Products Administration (NMPA) released its revised Good Manufacturing Practice (GMP) for medical devices, which will come into effect on November 1, 2026. This is the first major revision of the GMP since 2014, and forms part... Read More
A new regulation issued by China’s State Council outlines, for the first time, clear rules for the study and use of advanced biomedical technologies, including gene editing, CAR-T and NK cell therapies, as well as stem cell treatments. The Regulations on the... Read More
In mid-September, China’s National Medical Products Administration (NMPA) launched a 30-day review and approval pathway for investigational new drug (IND) applications to speed up clinical trial initiation for innovative pharmaceuticals. This pathway supplements the existing 60-day default approval pathway established in 2019.... Read More
To register medical devices in China, type testing is required. Whereas in the past, this testing needed to be done in China, China has now allowed for testing overseas. Given the long time it may take for type testing in China (anywhere... Read More
China’s 2025 revision of the National Reimbursement Drug List (NRDL) has been the most competitive in history, with a record-setting number of candidates qualifying for the first round of formal review. Through mid-August 2025, there are more than 300 drugs for new... Read More
The National Medical Products Administration (NMPA) of China has issued revisions to its clinical trial policies in an effort to shorten drug development timelines and encourage innovation. The revised guidelines, which became effective on September 2, 2025, are expected to reduce approval... Read More
China’s pharmaceutical/biotech market offers enormous sourcing and manufacturing opportunities for foreign companies. However, one major challenge remains – product quality is a major concern for foreign firms seeking to procure pharmaceutical products from Chinese factories. Good quality systems that meet China’s National... Read More