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
From July 14, 2025, Singapore’s Health Sciences Authority (HSA) will enforce a revised version of the guidance document GN-21 to streamline medical device change reporting. Low-risk changes such as label designs, new barcodes, and supplier changes do not need to be reported.... Read More
Korea is quickly expanding the use of AI in its drug regulatory and safety systems. Korea’s Ministry of Food and Drug Safety (MFDS) will start applying AI in drug review work starting next year as part of a wider attempt to innovate its regulatory... 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
On 29 June 2025, the Vietnamese Government promulgated Decree No. 163/2025/ND-CP (“Decree 163”) as part of their revised Law on Pharmacy. Decree 163 came into effect on July 1, 2025, and makes overall revisions in the areas of pharmaceutical regulation, certification of... Read More
On July 22, the Indian Department of Pharmaceuticals National Pharmaceutical Pricing Authority (NPPA) issued a Memorandum with respect to the maximum retail prices (MRP) for non-scheduled formulations for new drugs and medical devices. Essentially, it states that the NPPA monitors prices, and... Read More
Historically, Japan has required, in its Good Clinical Practice ordinance, each clinical trial site to have its own IRB, which means each site director needs to ask for an IRB review separately. Unfortunately, this makes doing trials at multiple sites overly complicated.... 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
Japan is the world’s third-largest medical device market. Thus, many foreign device companies are interested in exporting their devices there. However, being successful in Japan is a complex endeavor, and foreign device companies must consider several key factors before moving forward. Before starting device... Read More