Overview
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.
Designation criteria
To be designated under the SAKIGAKE Designation System, a product needs to meet the criteria below.
- Innovativeness:
Pharmaceuticals (any of the following is satisfied):
- A novel mechanism of action
- The first product with the same mechanism of action for the target disease
- An innovative drug delivery system
Medical devices:
- A novel technology or principle
In vitro diagnostics (any of the following is satisfied):
- A novel technology or principle
- A novel analyte or measurement target
Regenerative medical products:
- A novel mechanism of action
- Seriousness of the target disease (any of the following is satisfied):
- Serious life-threatening disease
- Disease with persistent symptoms causing difficulties in daily or social life and no radical treatment available
- Prominent efficacy (any of the following is satisfied):
- No approved treatment is available
- Significantly improved efficacy or safety is expected compared with existing therapies or diagnostics
- Intent and organizational capacity for development and application earlier in Japan ahead of the rest of the world:
- 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
To understand more designation criteria, please see the following notifications.
- 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]
Incentives
Designated products are eligible for the following incentives.
Financial incentives:
- Additional 10-20% premium drug pricing (MHLW)
Regulatory incentives:
- Priority consultation (PMDA)
- SAKIGAKE comprehensive assessment consultation (PMDA)
- Priority review (PMDA)
- Dedicated PMDA liaison (“concierge”) for development progress and regulatory coordination (PMDA)
SAKIGAKE Designation Procedure
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
Applicants are encouraged to first review the section entitled “About designation consultation” at the link below.
(Note) The website is written in Japanese. An English translation is available via the “Language” option next to the globe icon at the top of the website.
For pharmaceuticals:
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/tp150514-01_00001.html
For medical devices, in vitro diagnostics, and regenerative medical products:
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/000013196.html
Once you have the information, please complete the application form at the same link and submit your request for designation consultation to below contact point.
When you are oversea’s company and wish to have designation consultation, MHLW request you to prepare interpreter for smooth communication or to submit its consultation request through your Japanese representative.
Contact point for applicants who wish to obtain a SAKIGAKE designation
(Note) To block unsolicited emails being sent to MHLW, we request you to replace [at] with @, when you send an email.
Pharmaceuticals:
Pharmaceutical Evaluation Division, Pharmaceutical Safety Bureau, MHLW
E-mail: senku_iyakuhin[at]mhlw.go.jp
Medical devices, in vitro diagnostics, and regenerative medical products:
Medical Device Evaluation Division, Pharmaceutical Safety Bureau, MHLW
E-mail: kikikashinsa[at]mhlw.go.jp
Related content
Organization of the SAKIGAKE designation
The responsibilities of regulatory authorities involved are as follows.
Ministry of Health, Labour and Welfare (MHLW)
- Consultation on eligibility for SAKIGAKE designation
- Review of eligibility for SAKIGAKE designation
- Final decision of SAKIGAKE designation
Pharmaceuticals and Medical Devices Agency (PMDA)
- Preliminary evaluation of eligibility for SAKIGAKE designation
- Priority scientific consultation for clinical trials and dossiers for marketing authorization of designated products
- Priority scientific review of designated products for marketing authorization
Related links
Pharmaceuticals:https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/tp150514-01_00001.html
Medical devices, in vitro diagnostics, and regenerative medical products:
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/000013196.html
(Note) The above websites are written in Japanese. An English translation is available at the top of each website.