Japan’s health ministry wants to make it easier to bring repurposed drugs to market. At a July meeting, the Ministry of Health, Labour, and Welfare (MHLW) proposed a new filing category for medicines built on active ingredients whose reexamination period has already lapsed, provided the new product differs from the original approval in indication, dosing regimen, dosage form, or administration route.
Right now, anyone besides the original drugmaker typically needs to run their own non-clinical studies, with PMDA sorting out case by case what data is actually necessary. Under the plan, applicants could cite public review reports and existing literature to skip some non-clinical work. However, the MHLW cautioned that extra data may still be needed if the published data is thin. Companies are advised to conduct consultation sessions with the PMDA about their whole development plan well before filing.
Another key issue discussed was Sakigake, the priority-review track for breakthrough drugs that started as a pilot in 2015 and became law in 2019. The ministry will loosen the requirement that a company file in Japan no later than three months after initial filing overseas. Going forward, missing that window due to circumstances beyond a company’s control would not disqualify the candidate for Sakigake designation. Instead, the company would just need to file in Japan before the drug gains approval abroad. The MHLW also wants to let a second drug qualify for Sakigake status even if it shares the same mechanism and target indication as a drug already designated, as long as that earlier drug has not been approved yet.
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.