Japan Moves to Address Drug Gaps and Support Overseas Biopharma Trials

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 government to request development by pharmaceutical companies or invite new drug sponsors. The selected products span indications including advanced gastrointestinal tumors, cystic fibrosis, intra-abdominal and urinary tract infections, etc. Also, 4 of the 86 products were found not to meet the criteria for high medical necessity because of insufficient evidence of added benefit over existing therapies. Several other products were deferred,  pending further data collection from FY2026 onward.

In addition, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will introduce priority face-to-face consultations for overseas startups planning cancer clinical trials in Japan. To qualify, products must first enter the consultation pathway through the National Cancer Center’s service office for multi-regional clinical trials and meet three conditions: 1. There are no effective therapies available in Japan for the target disease; 2. the product is a new drug or regenerative medicine; and 3. clinical trials are planned in Japan. The framework applies to scheduling requests submitted on or after February 10, 2026. While the PMDA usually reviews consultation requests in order of receipt, the new system allows for the prioritization of selected products. Eligible emerging pharmaceutical companies, specifically those with global annual revenue under $500 million and R&D spending below $200 million, may also submit briefing materials in English.