Japan’s Cabinet Office is requesting 22 billion yen (about 143 million USD) in its FY2027 budget to help pay for clinical trials, as part of a wider push to invest in drug discovery and advanced medicine. All of the money will go... Read More
Japan’s in vitro diagnostics (IVD) market is set for steady growth over the next decade, according to two new market research reports. Dimension Market Research puts the market at over $15 billion in 2026 and projects the market to be $29 billion... Read More
Japan’s health ministry will designate a new class of “international hub” hospitals for clinical trials starting in fiscal 2027, aiming to attract more trial business from overseas drugmakers. A subcommittee under the Ministry of Health, Labour and Welfare approved the qualifying criteria... Read More
While many overseas medical device makers are hoping that approval in the “Country of Origin” will no longer be required for medical device registration in China, this regulation has not yet been changed in China. Under the current framework (Order 739), an imported... 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
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
Japan’s health ministry wants to make it easier to bring repurposed drugs to market. At a July meeting, the Ministry of Health, Labour, and Welfare (MHLW) proposed a new filing category for medicines built on active ingredients whose reexamination period has already... Read More
Japan’s annual economic policy blueprint, known as the “honebuto,” is expected to take a more proactive stance on pharmaceutical innovation this year. The 2026 draft includes a commitment to revisit how breakthrough medicines are priced at launch and how drug prices are... Read More
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