Accelerating Drug and Medical Device Development under the SAKIGAKE (Pioneering Review Designation) System
First written in FY2018-Q3. 2 of 3 entries say "Restated". Latest entry: FY2020.
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- FY2020RestatedAnnual report
「The Company conducts business alliances and joint research activities primarily to create new therapies for intractable, rare and pediatric diseases, while considering the use of systems such as the Ministry of Health, Labour and Welfare's Sakigake designation system to accelerate development research.」
Reconfirms the possibility of accelerating development by using systems such as the Sakigake designation system as part of its development policy. - FY2018RestatedAnnual report
「Because this product has been designated under the Ministry of Health, Labour and Welfare's Sakigake designation system, it is prioritized over products undergoing the ordinary approval review process. The Company will pursue research and development aimed at a steady and rapid launch while taking advantage of this status.」
Reconfirms that the regenerative medicine product using cardiac stem cells is covered by the Sakigake designation system and that the policy is to seek commercialization by taking advantage of priority review. - FY2018-Q3First statedAnnual report
「In October 2017, the third call for applications in total began for products eligible under the Sakigake designation system for pharmaceuticals. The system was introduced based on the "Sakigake Package Strategy: Promoting the Practical Application of Innovative Pharmaceuticals, Medical Devices, etc. Ahead of the Rest of the World," announced by the Ministry of Health, Labour and Welfare in June 2014. It positions the pharmaceutical and medical device industries as growth industries in Japan and is an important policy measure to accelerate pharmaceutical development by shortening the approval review period to commercialization for drug candidates that meet certain requirements, such as showing promise of significant efficacy at an early clinical trial stage. We understand this treatment to symbolize the high expectations placed on the industry. In December 2017, the first medical device submitted under the system was approved, and the system is steadily beginning to demonstrate its effects.」
The Sakigake designation system is described as a business environment demonstrating accelerated pharmaceutical and medical device development, including the third call for applications in October 2017, the mechanism for shortening approval review periods, and the first approval in December 2017 of a medical device using the system.