Sakigake (drug designation)

Sakigake Designation is a regulatory pathway in Japan aimed at facilitating the development and approval of innovative medical products. Established by the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW) in 2015, the Sakigake Designation system is part of Japan's strategy to promote research and development in the pharmaceutical and medical devices sectors, ensuring that groundbreaking therapies reach patients more swiftly.

Overview

The Sakigake Designation system targets new drugs, medical devices, and regenerative medicines that offer significant advancements in medical care. It is specifically designed for products that are first developed in Japan or for which development in Japan is significantly ahead of other countries. The designation provides a range of benefits to expedite the development, review, and approval processes, including prioritized consultation, a dedicated review system, and reduced review times.

Eligibility Criteria

To be eligible for Sakigake Designation, a product must meet several criteria:

• It must be a novel medical product with the potential to significantly advance the current standard of care.
• The development plan for the product should be based in Japan, and it should be intended for early launch in the Japanese market.
• The applicant must present a clear plan for the development of the product, including timelines for clinical trials and marketing.

Benefits

Products receiving the Sakigake Designation benefit from:

• Prioritized consultation services with the PMDA, including advice on clinical trial design and manufacturing.
• A dedicated review system that ensures a faster review process compared to standard procedures.
• Reduced review times, with the goal of achieving early approval and market access.

Application Process

The application process for Sakigake Designation involves submitting detailed information about the product, its development plan, and evidence supporting its innovative nature and potential benefits. The PMDA and MHLW review the application to determine if the product meets the eligibility criteria for the designation.

Impact

Since its inception, the Sakigake Designation system has had a significant impact on the pharmaceutical and medical device industries in Japan. It has facilitated the development and approval of several innovative products, improving patient access to new treatments and therapies. The system also underscores Japan's commitment to becoming a global leader in healthcare innovation.

See Also

• Pharmaceuticals and Medical Devices Agency
• Ministry of Health, Labour and Welfare
• Drug development
• Regenerative medicine