On June 16, 2025, China’s National Medical Products Administration (NMPA) released a new “Guidance for the Classification of In Vitro Diagnostic (IVD) Reagents Related to Next-Generation Sequencing (NGS),” effective immediately. The document explains classification and regulation rules for NGS-based IVDs and requests manufacturers... Read More
China is doing exceedingly well in developing new drugs and biotech products. About one-third of global MNC licensing deals are now with Chinese drugs in development. One of the reasons for China’s success is a large pool of science talent and the ability... Read More
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a substantial increase in unannounced inspections at foreign manufacturing facilities that manufacture medical products for U.S. import. This initiative is a result of a White House Executive Order directing agencies... Read More
On May 13, China’s NMPA promulgated a new list of medical devices exempt from clinical trials. This new list, an update to the 2023 list, identifies 27 medical devices, including seven Class 3 products and 20 Class 2 products. In total, 1047 medical... Read More
In a meeting on May 8, Mr. Katsufumi Jo of Japan’s Upper House Health Committee within the Ministry of Health, Labour and Welfare (MHLW) described the scope of Japan’s newly widened conditional approval scheme for drugs. He said that the expanded scheme is intended to... Read More
As relationships with China falter and China wants to make everything in-country, more Western device companies are looking to India not only for sales, but for sourcing, R&D, local manufacturing, etc. The Indian government has promoted medical device manufacturing via its National... Read More
Introduction In the fast-paced medical device industry, product quality is essential to guaranteeing patient safety and public confidence. Across the world, regulatory bodies have established stringent quality systems to manage and enforce standards throughout the life cycle of a device. In Asia,... Read More
Asia’s growing healthcare needs and aging populations offer a significant opportunity for medical device manufacturers from around the world. However, market access to the biggest economies in Asia – China, Korea, and Japan – usually entails navigating complicated and rapidly changing reimbursement... Read More
As global drug companies look to expand into Asia, having insight into the drug market access environment in China, Korea, and Japan is more important than ever. Although the drug registration procedure is getting less complicated in these markets, market access in... Read More
In the international pharmaceuticals industry, Good Manufacturing Practice (GMP) compliance is a fundamental foundation for the safety, quality, and efficacy of drugs. With expanding supply chains and more complex global partnerships, knowledge of the quality compliance environments of leading Asian pharmaceutical markets... Read More