Japan’s Ministry of Health, Labour and Welfare (MHLW) has issued new notifications clarifying how pediatric drug development will be handled under amendments to the Pharmaceuticals and Medical Devices Act. These notifications will take effect on May 1, 2026. The measures aim to strengthen... Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) will expand the eligibility criteria for its “specific-use drug” designation to support the development of drugs addressing significant unmet medical needs. The revised rules, announced on February 27, will take effect on May 1... Read More
Japan’s orphan drug designation (ODD) system is designed to promote the development of therapies for rare diseases that affect small patient populations. Because these rare diseases often lack commercially attractive markets, special regulatory and financial incentives are necessary to encourage innovation in... Read More
Background and Legal Framework Japan’s Unique Device Identification (UDI) system was formally established under the 2019 amendment to the Pharmaceutical and Medical Devices Act (PMD Act). The act was amended in 2019 as part of a major reform effort by the Japanese... Read More
On February 6, Japan’s Ministry of Health, Labour and Welfare (MHLW) designated 10 of 86 identified “drug loss” products (innovative products approved in the US and EU that are not available in Japan) as having high medical need. This designation enables the... Read More
In January 2026, Japan’s Ministry of Health, Labour and Welfare (MHLW) issued a new notice clarifying the regulatory procedures for changes to raw materials used in medical devices. The notice replaces the prior guidance from 2013 to determine when a raw material... Read More
In December 2023, Japan introduced important regulatory changes that significantly reshape global drug development strategies. Under new guidance issued by Japan’s Ministry of Health, Labour and Welfare (MHLW), drug developers will now be allowed to include Japanese subjects in their multi-regional clinical... Read More
For drug companies planning development in Japan, consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) are a practical way to align your strategy with the Japanese health authority’s expectations before you commit to costly studies and other market entry issues in... Read More
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