Japan's SAKIGAKE designation: what it is and what it is not

Creator: Reserve Meds
Published: 2026-10-17

A plain explanation for patients, families and doctors, checked against the regulator's own pages on 17 October 2026.

Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.

The short answer

SAKIGAKE is a Japanese strategy, announced by the Ministry of Health, Labour and Welfare on 17 June 2014, to lead the world in bringing innovative medical products to patients. Its designation system gives promising products priority consultations, prior assessment and priority review, with the PMDA implementing it. It speeds up approval in Japan; it is not an access route for patients abroad.

Who runs it: MHLW, implemented with the PMDA.
Announced: 17 June 2014.
What designation gives: Priority consultations, prior assessment and priority review.
Patient access abroad: Not a route; local rules apply.

What SAKIGAKE is

On 17 June 2014, MHLW announced the Strategy of SAKIGAKE to lead the world in the practical application of innovative medical products. It covers everything from basic research to clinical trials, approval reviews, safety measures, insurance coverage, infrastructure and global expansion.^[1]

One of its main policies is the SAKIGAKE Designation System, which promotes research and early clinical trials in Japan for innovative products with prospects of significant efficacy, through priority consultations, prior assessment and priority reviews. The PMDA works with MHLW to implement it.^[1]

What it means for patients

A SAKIGAKE designation is good news for a product's timeline in Japan. It does not make a product available elsewhere, and it does not create a special import route.

Patients in Japan who want to bring medicines from abroad follow MHLW's personal import rules, including the Import Confirmation where needed. See our Japan country guide.^[2]

For patients in the Gulf, the relevant question is whether the medicine is approved by the US FDA and how the local regulator handles unregistered medicines.^{[3, 4]}

How it compares with US and EU programs

SAKIGAKE is one of several expedited programs: the US has Breakthrough Therapy designation and accelerated approval, and the EU has PRIME and conditional marketing authorisation. Each has its own criteria. None of them by itself lets a patient obtain an unapproved product; that needs a trial, expanded access or a national compassionate route.^{[5, 6, 7]}

How FDA's four expedited programs compare

Fast Track: for drugs that treat serious conditions and fill an unmet need. It brings more frequent FDA meetings and written communication, possible rolling review of completed sections of the application, and eligibility for accelerated approval and priority review if criteria are met.^[8]
Breakthrough Therapy: for drugs whose early clinical evidence suggests substantial improvement over available therapy. It includes all Fast Track features plus intensive guidance from Phase 1 and senior management involvement.^[5]
Accelerated Approval: an approval based on a surrogate or intermediate endpoint reasonably likely to predict benefit, with confirmatory trials required.^[9]
Priority Review: FDA's goal is to act on the application within 6 months, compared with 10 months under standard review. We give you a written timeline estimate for your case before you commit.^[10]

Only accelerated approval is an approval. The other three change how a drug is developed or reviewed; none of them makes a drug available before approval.

What the designation offers developers

Under the designation system, the PMDA and MHLW offer priority consultations, prior assessment of data before the formal application, and priority review. The aim is early practical application in Japan of innovative products with prospects of significant efficacy. For SAKIGAKE-designated medical devices, the PMDA publishes a target review timeframe of 6 months.^{[1, 11]}

Questions to ask the treating specialist

Is the product approved in Japan, the US or elsewhere yet?
If approved in the US, could the hospital in our country request it for the named patient?
If not approved anywhere, is there a trial we could join?

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.

We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.

Ask us whether a medicine can reach your patient

Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.

Frequently asked questions

What is SAKIGAKE?

A Japanese strategy announced by MHLW on 17 June 2014, including a designation system that gives innovative products priority consultations, prior assessment and priority review.

Who implements SAKIGAKE?

MHLW, together with the Pharmaceuticals and Medical Devices Agency (PMDA).

Can a patient outside Japan use SAKIGAKE to get a medicine?

No. It speeds up approval in Japan. Patients elsewhere follow their own country's routes.

Is SAKIGAKE like FDA Breakthrough Therapy?

Both support promising products during development, but they are separate programs with different rules.

Sources for these answers: ^{[1, 2]}

Sources

All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.

PMDA Japan: Strategy of SAKIGAKE by MHLW (accessed 17 October 2026)
Ministry of Health, Labour and Welfare Japan: Information for those who are bringing medicines for personal use into Japan (accessed 17 October 2026)
US FDA: How do I find out if a drug is approved? (accessed 17 October 2026)
SFDA: Special Access Program (SAP) guidance, version 1.0 (accessed 17 October 2026)
US FDA: Breakthrough Therapy (accessed 17 October 2026)
European Medicines Agency: PRIME, priority medicines (accessed 17 October 2026)
US FDA: Expanded Access (accessed 17 October 2026)
US FDA: Fast Track (information for patients) (accessed 17 October 2026)
US FDA: Accelerated Approval Program (accessed 17 October 2026)
US FDA: Priority Review (information for patients) (accessed 17 October 2026)
PMDA: About PMDA (English brochure), SAKIGAKE medical device designation, target review timeframe 6 months (accessed 17 October 2026)

This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.