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 designation targets therapies for high unmet medical needs, such as pediatric conditions and antimicrobial resistance, and provides incentives, including priority review and access to public support measures.
Under the current system, eligibility assessments are typically initiated through the MHLW’s Council on Unapproved Drugs and Indications with Unmet Medical Needs, based on proposals from academic societies or individuals. The new framework enables drug companies to directly seek PMDA review when a case has not already been examined by the Council. This will be followed by consultation with the Pharmaceutical Affairs Council’s drug committees. The change will shorten timelines for designation by expanding opportunities for review outside the current Council process.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.