Introduction to the New Clinical Trial Initiative
According to the official notification issued by Japan’s Ministry of Health, Labour and Welfare (MHLW) on February 10, 2026, the government announced strengthened collaboration between the International Joint Clinical Trial One-Stop Consultation Window and the Pharmaceuticals and Medical Devices Agency (PMDA).
This initiative aims to address Japan’s persistent challenges of drug lag and drug loss by attracting international clinical trials and improving the country’s development environment. The policy is particularly designed to support overseas startups and pharmaceutical companies without a development base in Japan, encouraging them to conduct clinical trials domestically.
Priority Handling of PMDA Face-to-Face Consultations
For products consulted through the One-Stop Window, PMDA will provide priority handling of face-to-face consultations if all of the following conditions are met:
Medical necessity will be assessed in accordance with existing priority review principles through individual discussions between the One-Stop Window and the PMDA.
English Submission for Emerging Biopharma Companies
Among products eligible for priority consultation, if the sponsor qualifies as an emerging biopharma company (for example, global annual revenue under USD 500 million and R&D expenditure under USD 200 million) and does not have a Japanese subsidiary, PMDA may allow submission of consultation materials in English on a case-by-case basis.
This measure significantly reduces operational barriers for overseas biotech companies considering entering Japan.
Procedural Requirements
Sponsors wishing to utilize priority consultation handling or English-language submission must first consult with the International Joint Clinical Trial One-Stop Consultation Window.
The new framework applies to products for which requests to schedule PMDA face-to-face consultations are submitted on or after February 10, 2026.
Strategic Implications for Global Development
This policy represents Japan’s proactive step to compete for international clinical trials. By integrating government support functions into PMDA’s regulatory processes, Japan is reducing entry friction for foreign sponsors and signaling greater openness to global innovation.
For emerging biopharma companies, particularly those targeting high unmet medical needs, this initiative offers an opportunity to incorporate Japan into global clinical development strategies earlier.
Conclusion
Japan’s strengthened collaboration between the International Joint Clinical Trial One-Stop Consultation Window and PMDA demonstrates a clear commitment to improving its clinical trial environment and reducing drug lag. By introducing priority consultation handling and allowing English documentation under defined conditions, Japan is making tangible progress toward becoming a more accessible and globally integrated development market.
Reference: T260210G0020.pdf