Japanese Ministry of Health, Labour, and Welfare (MHLW) has formed the “Strategy of SAKIGAKE” to lead the world in the accelerated approval process and prompt practical application of innovative medical products including medical devices. The Strategy of SAKIGAKE covers from basic research to clinical research/trials, approval reviews, safety measures, insurance coverage, improvement of infrastructure and the environment for corporate activities, and global expansion. Two major components of SAKIGAKE are:
- SAKIGAKE Designation System: promoting R&D aiming at early practical application of innovative pharmaceutical products, medical devices, and regenerative medicines.
- Scheme for Rapid Authorization of Unapproved Drugs: accelerating the practical application of unapproved/off-label use of drugs for serious and life-threatening diseases by expanding the scope of the Council on Unapproved Drugs/Off-label Use to include indications unapproved in Western countries if it satisfies certain conditions. It is aimed to improve the environment for companies to undertake development of such drugs.
Major points which are of interests to medical device manufacturers from the strategy of SAKIGAKE are as follows:
- Guidelines for medical devices including next-generation ventricular assist devices, minimally invasive therapeutic instruments, orthopedics and dentistry, and stent durability tests will be prepared.
- The environment for development of orphan drugs for treatment of diseases with very few patients (i.e. ultra-orphan drugs, devices, and regenerative medicines) will be improved by clarifying the designation criteria and accelerating early designation. In addition, further support measures including rational designation and evaluation methods will be implemented to facilitate research and development of the products mentioned above.
- Accelerated review process will be implemented to improve the quality of reviews and shorten the lag in review period considering the innovative nature and urgent clinical need for the medical devices.
- The structure of the Pharmaceuticals and Medical Devices Agency (PMDA) will be organized to accommodate introduction of electronic submission of clinical trial data for new drug approval. Electronic submission should be accepted by the PMDA beginning in 2016. Moreover, the PMDA will conduct their own research and analysis with modeling and simulation using clinical trial data, and provide advice to improve the quality of review and consultation.
- An increase in the number of accepted documents in English in application dossier will be considered.
- When pharmaceutical products, medical devices, and regenerative medicines targeted for diseases which require innovative treatments demonstrate substantial improvement over conventional therapies in early clinical trials (phase 1 or 2a), the products will be prioritized for consultation and reviews (e.g. prioritized consultation for clinical trials, pre-application consultation, and prioritized review) to accelerate the prompt practical application.
- Efforts will be made to assure post-marketing efficacy and safety, such as streamlining post-marketing information collection and reducing its workload. This will be achieved by constructing a system of patient registry for regenerative medicines and implantable medical devices.