Japan has emerged as one of the more progressive markets when it comes to SaMD. While the concept of software-based medical tools is hardly new, the country’s formal regulatory recognition of SaMD reflects a deliberate effort to keep pace with the rapid... Read More
Japan’s government has sounded the alarm over the United States’ most-favored-nation (MFN) drug pricing policy, warning it risks worsening the country’s longstanding struggles with its drug lag problem. Officials fear that as pharmaceutical companies grow more cautious about entering the Japanese market, where... Read More
Japan’s health ministry is urging pharmaceutical companies to choose institutional review boards (IRBs) carefully, as the country prepares to overhaul its Good Clinical Practice rules. The forthcoming revision, due to be promulgated this summer, will allow trial sponsors to directly select a... Read More
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