Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the entry of 11 new drugs into the National Health Insurance (NHI) reimbursement system effective May 21, 2025. The newly listed drugs include BeiGene’s cancer immunotherapy Tevimbra (tislelizumab), Servier’s Tibsovo (ivosidenib) for... Read More
Japan’s 2025 AI Bill highlights a regulatory change that values innovation rather than restriction, specifically in the pharmaceutical industry. In contrast with the EU’s rule-based system, Japan promotes voluntary compliance and collaboration, with flexible guidelines that speed up drug development. While this... Read More
This article was originally posted on MedTech Intellligence Oftentimes, obtaining the right medical device reimbursement in Japan is more important than both the expected need/demand for your product and medical device registration. Of course, all three things are important. However, if the... Read More
On May 14, 2025, the Japanese government amended the Pharmaceutical and Medical Device Act 2025. Prior to this update, the PMD Act only outlined the roles and responsibilities of the MAH’s key responsible people. It did not have any specific penalties or rules... Read More
In December of last year, we published a news brief explaining that Foreign Reference Pricing is becoming less important in Japan for device reimbursement. Today, Japan’s medical device reimbursement normally closely follows the reimbursement in Europe, not the US and Australia, which are... Read More
As mentioned in our newsletter over the last 18 months, Japan is now taking a more aggressive posture to tackle the issue that many drugs in the West are not yet available in Japan. To help speed up the process, the MHLW has... Read More
Introduction In the fast-paced medical device industry, product quality is essential to guaranteeing patient safety and public confidence. Across the world, regulatory bodies have established stringent quality systems to manage and enforce standards throughout the life cycle of a device. In Asia,... Read More
Asia’s growing healthcare needs and aging populations offer a significant opportunity for medical device manufacturers from around the world. However, market access to the biggest economies in Asia – China, Korea, and Japan – usually entails navigating complicated and rapidly changing reimbursement... Read More
As global drug companies look to expand into Asia, having insight into the drug market access environment in China, Korea, and Japan is more important than ever. Although the drug registration procedure is getting less complicated in these markets, market access in... Read More
In the international pharmaceuticals industry, Good Manufacturing Practice (GMP) compliance is a fundamental foundation for the safety, quality, and efficacy of drugs. With expanding supply chains and more complex global partnerships, knowledge of the quality compliance environments of leading Asian pharmaceutical markets... Read More