India’s health ministry has put together a proposal to overhaul the country’s pharmaceutical rulebook, much of which has been in place since 1940. The draft Drugs, Medical Devices and Cosmetics Bill 2026 will reshape how the country brings new drugs and devices to market and manages... Read More
China’s National Health Commission has issued new nationwide rules requiring public hospitals and healthcare institutions to buy major medical equipment through centralized procurement channels. This new policy is different than past situations where hospitals sourced purchases individually. Announced on July 14, the framework divides equipment... Read More
Vietnam’s Ministry of Health has issued a new circular, taking effect on October 1, 2026, aimed at streamlining drug registration. The update is designed to cut down on paperwork and procedural delays that have long been a pain point for foreign companies... Read More
Thailand’s FDA has issued a new notification, effective July 16, 2026, that changes the documentation required to renew a drug registration certificate. Renewal is no longer a routine administrative step, as applicants must now demonstrate that their quality, efficacy, and safety documentation... Read More
Generally, for new or unique medical device registration in Japan, a local Japanese clinical trial will be needed. However, in some cases, a separate Japanese trial is not required for device approval. Please keep in mind that the PMDA will normally not... Read More
Japan is the world’s third-largest medical device market after the US and China. With a very large aging population and an increase in chronic diseases, the opportunities for advanced Western medical devices that can help expedite patient care and reduce hospital patient... Read More
China’s National Medical Products Administration (NMPA) has proposed draft measures to speed up reviews of cell and gene therapies. It is taking public comments for one month. The plan covers products for cancers, rare diseases, immune disorders, neurodegenerative conditions, and genetic disorders.... Read More
India’s Central Drugs Standard Control Organization (CDSCO) released its finalized Guidance Document on Medical Device Software (The Guidance Document) on July 21, 2026. The Guidance Document provides comprehensive guidance dedicated to the regulation of medical device software (MDSW) under India’s existing Medical... Read More
Japan and the US have begun negotiating a mutual recognition agreement covering GMP inspections of pharmaceutical manufacturing plants, a step that could ease the regulatory burden on drug makers exporting between the two countries. Under such a deal, US and Japanese regulators... Read More
Korea’s Ministry of Health and Welfare announced on June 30 a pilot program to speed up health insurance listing for rare disease treatments. The process will take only 100 days, down from 240 days. Under the pilot, cost-effectiveness assessments will happen after... Read More