Japan is one of the world’s most important pharmaceutical markets, but foreign manufacturers cannot access it without first meeting Japan’s regulatory requirements. Besides submitting a Japanese drug registration dossier, clinical trial information, etc., — for drugs or quasi-drugs manufactured overseas, the applicant must... Read More
Japan continues to lag behind the United States in the registration of AI-based Software as a Medical Device (AI-based SaMD), particularly for products that continuously update after commercialization. Under Japan’s current regulatory framework, the Pharmaceuticals and Medical Devices Agency (PMDA) does not... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) has issued a Q&A document clarifying how the revised conditional approval system under the amended Pharmaceuticals and Medical Devices (PMD) Act will be implemented as of May 1, 2026. The updated framework expands the... Read More
Japan’s FY2026 drug price revision, which took effect in April 2026, brings another round of pricing cuts under the country’s National Health Insurance (NHI) system. Overall, drug prices were reduced by about 4%, with authorities continuing efforts to control healthcare spending as... Read More
In May 2026, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) created a dedicated English-language webpage on orphan drug designation. The page is designed to be a central resource for sponsors seeking information on Japan’s orphan drug program, including designation requirements, incentives available... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) has issued a notification confirming that information used to recruit participants for clinical trials will now not be classified as “advertising,” as long as it is limited to necessary recruitment content. In the past, this was not allowed... Read More
Singapore’s Health Sciences Authority (HSA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) signed a Memorandum of Cooperation in Tokyo on April 20, 2026. The agreement aims to bring the two regulators closer together in how they oversee drug products. At... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) has issued new notifications clarifying how pediatric drug development will be handled under amendments to the Pharmaceuticals and Medical Devices Act. These notifications will take effect on May 1, 2026. The measures aim to strengthen... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) will expand the eligibility criteria for its “specific-use drug” designation to support the development of drugs addressing significant unmet medical needs. The revised rules, announced on February 27, will take effect on May 1... Read More
Japan’s orphan drug designation (ODD) system is designed to promote the development of therapies for rare diseases that affect small patient populations. Because these rare diseases often lack commercially attractive markets, special regulatory and financial incentives are necessary to encourage innovation in... Read More