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
Drug reimbursement is a key issue in Japan, especially as the country wants to promote innovative therapies and reduce the drug lag/loss there. Over the last few months, the MHLW, Central Social Insurance Medical Council (Chuikyo), the Japan Pharmaceutical Association, and other... Read More
Singapore’s Health Sciences Authority (HSA) has strengthened international regulatory collaboration through two Memoranda of Understanding (MOUs) signed during the 16th International Conference on Medical Regulation 2025. On September 4, the HSA signed an MOU with Australia’s Therapeutic Goods Administration (TGA) to facilitate... Read More
On July 7, Japan’s PMDA published its GMP annual report for 2024. Japan’s PMDA has reported that many foreign drug companies are not meeting Japan’s GMP standards. In 2024, there were 126 on-site GMP inspections and 2,049 desktop GMP inspections. These figures... Read More