Japan · Ministry of Health, Labour and Welfare · New drugs
Review target
183 days
performance goal
Legal time limit
-
Not published
Steps
5
3 requirements
Application fee
-
The health minister can designate a drug, device or regenerative product as pioneering when its mechanism or principle clearly differs from products approved in Japan or abroad and it is expected to be especially useful. Designated products get priority review, can qualify for conditional approval, and drugs can get a longer re-examination period. The PMDA target is a total review time of about 6 months. An innovative product with a clearly new mechanism of action (drugs, regenerative products) or a clearly new principle (devices, IVDs), expected to be especially useful.
The official review target is 183 days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Apply for designation; 2. Pharmaceutical Affairs Council opinion; 3. Designation and public notice; 4. Priority review of the approval application (183 days); 5. Approval.
Outcome: Designation, publicly announced. Later approval applications get priority review.
Legal basis: Pharmaceuticals and Medical Devices Act, Article 77-2(2), Article 14(11), Article 14-2-2 and Article 14-4
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 183 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal. About 6 months total review time for designated new drugs approved in FY2026. This is an official performance target, not an actual review time. It counts total time from filing to approval, including the applicant's time. | 183 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Japan: Approval of a drug with a new active ingredient, Approval of a known active ingredient with a new route, indication, dosage form or dose, Approval held by a foreign manufacturer through a designated marketing authorization holder, Priority review, Fast priority review of a product already sold abroad during a supply shortage, Conditional approval, Orphan designation, Specific-use product designation, Special approval for emergencies (based on foreign approval), Emergency approval (time-limited), Approval of a regenerative medical product (cell or gene therapy), Conditional and time-limited approval of a regenerative medical product, Notification of a Class I device or a low-risk IVD, Third-party certification by a registered certification body, Approval of a new medical device. See all routes on the Japan page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.