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
China’s National Medical Products Administration (NMPA) issued a sweeping new policy to encourage the innovation and international competitiveness of high-end medical devices. Published in July 2025, the “Announcement on Optimizing Whole-Life-Cycle Regulation to Support Innovative Development of High-End Medical Devices” specifies ten... Read More
On July 30, 2025, the Medical Device Authority of Malaysia (MDA) launched the Malaysia–China Medical Device Regulatory Reliance Program (Pilot Phase I) with an end date of September 30, 2025. The program uses the Global Harmonization Working Party (GHWP) structure to form... Read More
Western drug makers are increasingly looking to Chinese biotechnology companies specializing in artificial intelligence to discover new medicines. A number of new multi-billion-dollar deals are a testament to China’s emerging status as a hub for cutting-edge medicines. In June, AstraZeneca paid more... Read More
In July, Vietnam issued Circular 30, which replaced Circular No. 11/2018/TT-BYT and its amendments with respect to drug quality standards. With respect to quality, drugs in Vietnam need to meet the Vietnamese Pharmacopoeia or the US, EU, British, Japanese, or International Pharmacopoeia.... Read More
As China’s medical device sector grows rapidly, it has become a key global manufacturing hub for a wide range of device products, from basic consumables to high-risk implantable devices. This expansion has been accompanied by more stringent regulatory control, with the National... Read More