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
China Medical Device Regulatory Landscape: A 2025 Update Over the last year, there have been significant changes to China’s medical device regulatory environment as the government tries to strengthen regulatory oversight and improve market access for innovative products. The National Medical Products... Read More
China’s National Medical Products Administration (NMPA) recently released a draft guideline permitting foreign medical device manufacturers to use accredited overseas labs to conduct product self-testing (type testing) as part of their China medical device registration. The public comment period ends in July. The guideline is a significant step toward... Read More
On July 10, China promulgated its 2025 National Basic Medical Insurance, Maternity Insurance, and Work-Related Injury Insurance Drug Catalogue Adjustment Work Plan. This is an upgrade over the 2024 Basic Medical Insurance Scheme. The main component is the formal introduction of the Commercial... Read More
Historically known for their strength in generic drug manufacturing, today, Indian pharma firms are increasing their in-licensing transactions with international drug innovators. Big Indian pharma firms such as Cipla, Sun Pharma, and Dr. Reddy’s are acquiring rights to new patented products in the oncology, diabetes, central... Read More
China’s National Health Commission (NHC) and National Healthcare Security Administration (NHSA) have announced a new policy entitled “Several Measures to Support the High-Quality Development of Innovative Drugs.” Published on June 30 and officially effective on July 1, the policy details 16 measures... Read More