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Pharmaceuticals and Medical Devices Agency (Japan) pmda.go.jp

[SHINSA]The new website “Overview of SAKIGAKE Designation“ launched.

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Announcement

The SAKIGAKE Designation is to promote the development of innovative pharmaceuticals, medical devices, in vitro diagnostics, and regenerative medical products for early practical use in Japan ahead of the rest of the world. When you get this designation based on the criteria, you can obtain special support for designated products throughout the development phase.

To be designated under the SAKIGAKE Designation System, a product needs to meet the criteria below.

Pharmaceuticals (any of the following is satisfied):

  • The first product with the same mechanism of action for the target disease

    • In vitro diagnostics (any of the following is satisfied):

  • Disease with persistent symptoms causing difficulties in daily or social life and no radical treatment available
  • Significantly improved efficacy or safety is expected compared with existing therapies or diagnostics
  • Plans to submit the marketing authorization application in Japan ahead of, or at the same time as, other countries/regions
  • Having an organization and development plan that enable early development and application in Japan
  • Partial Revision of “Handling of Designation of Innovative Pharmaceutical products under the SAKIGAKE system: Japanese original [298KB]／English Version[235KB]
  • Partial Revision of “Handling of Designation of Innovative medical devices, in vitro diagnostics, and regenerative medical products under the SAKIGAKE system: Japanse original [158KB]／English Version[124B]

    • Designated products are eligible for the following incentives.

  • Additional 10-20% premium drug pricing (MHLW)
  • SAKIGAKE comprehensive assessment consultation (PMDA)
  • Dedicated PMDA liaison (“concierge”) for development progress and regulatory coordination (PMDA)

    • An overview of the SAKIGAKE designation process for pharmaceuticals is shown in the figure below (including the designation consultation and application phases).

    Figure: SAKIGAKE designation process for pharmaceuticals

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    Source: Pharmaceuticals and Medical Devices Agency (Japan) website. Licence

    Read the original at the source: https://www.pmda.go.jp/english/review-services/reviews/0012.html

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    October 03, 2026 20:39
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    https://www.pmda.go.jp/english/review-services/reviews/0012.html

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