2022年9月1日 · This revision of the PMD-Act establishes Sakigake as a permanent system and went into effect on September 1, 2020. The Act allows applicants to seek Sakigake designation at any time; under the pilot system, applicants were allowed to seek this designation only during a narrow window of time (approximately one month) only once a year.

2017年12月15日 · The titanium bridge, which treats adductor spasmodic dysphonia (AdSD, a voice disorder), was the first medical device to receive the sakigake designation and emerges as a success story from the first round of reviews that started in 2016. Filed for market approval in July 2017, the device was approved less than 6 months later, in December 2017.

Sakigake aims at early marketing applications for innovative pharmaceutical products, medical devices, and regenerative medicines, and products that win this designation are assigned a PMDA review manager specifically for that product to facilitate its development and review. Marketing applications must be filed in Japan prior to or at the same ...

SAKIGAKE Designation System – This system is applicable to innovative medicines, medical devices, or regenerative medical products in practical use in Japan sooner than or simultaneously with other countries, aiming at early practical application with various supports such as “Rolling Review,” “Priority Consultation,” and “Priority Review.”

Diverse discussions, driven by a common desire to make progress in developing new medical products effectively and efficiently through global collaboration, ranged from the costs of R&D to clinical trials, real world evidence, accelerated pathways such as sakigake, AI applications in drug development, patient centricity and engagement ...

* This “Japan-(almost)-first rule” happens to coincide with one of the criteria for the Sakigake designation, the counterpart to the US Breakthrough Therapy and EU PRIME designations. However, Sakigake rewards a small number of truly innovative drugs with intimate regulatory consultation and ultrarapid approval review. The rule mentioned ...

This ongoing, promising development program will be “fast tracked” by its SAKIGAKE designation. Dr. Kiyohito Nakai (Director, Pharmaceutical and Food Safety Bureau, MHLW) illustrated the agency’s regulatory leadership to promote industrialization of regenerative medical products originating in Japan. A second example of such leadership ...

This concept was put forward and fully supported by regulators from MHLW and PMDA, including MHLW keynote speaker Kiyohito Nakai, (one of the leaders in regulatory science, the SAKIGAKE designation scheme, and the early approval scheme in Japan) and PMDA’s Yoshiaki Uyama, who has been leading the important “national initiative for ...

arlier this year, DIA held its first Regulatory Affairs Leadership Forum as part of DIA Europe 2020.The proposal was ambitious: to gather a diverse panel of people who work in different fields and discuss the value and skills that regulatory professionals bring to medicines research and development and the pharmaceutical industry of the future.

Japan has Priority Reviews, Conditional Approvals, and sakigake Designations. Canada has a Priority Review pathway. Canada has a Priority Review pathway. China is accelerating its review process for both clinical trial applications and marketing applications, and is considering a Conditional Approval pathway as well as the acceptance of foreign ...