Japan Moves to Boost Drug Development and Address Shortages

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 following amendments to the Pharmaceuticals and Medical Devices (PMD) Act. The program currently encourages development of treatments such as pediatric medicines and antibiotics targeting antimicrobial resistance (AMR), offering incentives including priority review, extended re-examination periods, and development subsidies. Under the revision, eligibility will expand to include new molecular entities (NMEs) for these categories. In addition, pharmaceutical companies will be able to directly request the designation through consultations with the MHLW. However, the existing pathway, where academic societies or healthcare professionals nominate candidates, will remain in place.

In addition, the MHLW will introduce a priority review pathway to speed approval of overseas medicines when domestic drug shortages significantly affect patient care. The policy was announced on February 27 and will take effect on May 1, following amendments to the PMD Act. Under the new framework, drugs already approved in countries such as the US, UK, Canada, Germany, or France may qualify for expedited review in Japan if no suitable alternative is available domestically. Eligible products must have the same active ingredient, administration route, dosage, and indications as an already approved drug in Japan, but currently lack available supply. The MHLW will determine eligibility after consulting with the applicant. Certain labeling requirements may also be temporarily relaxed to enable faster distribution of approved products. Companies may begin consulting with the Ministry about the pathway before the policy formally takes effect.