On January 14, Japan’s Central Social Insurance Medical Council (Chuikyo) implemented new pricing regulations for regenerative medicine products that are granted conditional and time-limited approval through a new pricing model. This new pricing model will be applied for the first time to the gene therapy... Read More
Approximately 50% of global clinical trials are conducted in the Asia Pacific region today. The clinical trial landscape of Asia has been expanding beyond China in recent years. Although over 60% of the clinical trials in the region were initiated in China... Read More
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is strengthening its role as a global regulator by offering more and more registration support for foreign pharmaceutical and medical device manufacturers. The PMDA has established overseas offices, accelerated pathways for product approval, developed harmonized... Read More
Over the past year, Japan has initiated a series of regulatory and policy reforms aimed at accelerating drug development, strengthening oversight, and improving access to innovative therapies, while also reinforcing international regulatory cooperation. FY2026 Budget Increase The MHLW estimated budget for FY2026... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) will introduce a new pathway from May 2026, allowing pharmaceutical companies to directly request an eligibility assessment from the Pharmaceuticals and Medical Devices Agency (PMDA) for designation as a “drug for specific use.” The... Read More
Japan’s Cabinet Office has recently approved a 330 billion JPY (2.1 billion USD) support package to encourage drug discovery and strengthen the country’s biopharma sector. Key allocations include nearly 50 billion JPY (323 million USD) for bioclusters and biotech infrastructure, 20 billion... Read More
Japan’s market for Software as a Medical Device (SaMD) is on track for remarkable growth, expanding from approximately 20 million USD in 2024 to more than 95 million USD in 2033. From 2025 through 2033, the SaMD market is forecasted to grow... Read More
As mentioned last month, drug pricing negotiations are now underway in Japan, in line with the Fiscal System’s Council guidance for the FY2026 budget. In contrast to the Japan Pharmaceutical Association’s desire for higher prices, the Japanese Ministry of Finance (MOF) is... Read More
Japan is the world’s third-largest device market. Similar to the drug lag, Japan is now beginning to see a device lag. The reason for this is that although Japan wants and needs innovative devices for its citizens, especially innovative devices that will... Read More
Ten to twenty years ago, Japan medical device reimbursement normally equaled the reimbursement in the US, or in a few cases, even higher. During this time, some device companies had 10% of their sales in Japan, with more than 10% of their... Read More