The PMDA Sakigake (Pioneering Drug Designation) pathway has been developed by the Pharmaceuticals and Medical Devices Agency of Japan.
This pathway can be used where Sakigake was designed to provide easier access to novel advanced treatments. It is similar to the regenerative medicine advanced therapy designation in the US and the advanced therapy medicinal product designation in the EU, as well as to BTD and PRIME. Sponsors are offered the opportunity to seek presubmission advice, which provides clients with a fixed-price, multitrack review of their application. .
This pathway facilitates activities during development.
Option 1: Application is to be submitted to Evaluation and Licensing Division (ELD) and to be reviewed by PMDA. The result of designation is to be notified within 60 days. Option 2: ELD is to approach a potential applicant. The result of designation is to be notified within 30 days after the submission, if agreed by the applicant.