Japan · Ministry of Health, Labour and Welfare · New drugs
Review target
274 days
performance goal
Legal time limit
-
Not published
Steps
5
3 requirements
Application fee
-
The health minister may review a product ahead of others when it is an orphan, pioneering or specific-use product, or another product with a high medical need. A new product for a serious disease that is clearly better than existing options can also qualify. The PMDA target for priority new drugs is shorter than for standard ones. A designated orphan, pioneering or specific-use product, or a new product for a serious disease that is clearly better in efficacy or safety than existing treatments.
The official review target is 274 days (performance goal, met in 80% of cases). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Pre-application consultation; 2. File the application and request priority review; 3. Decision on priority status; 4. Priority review; 5. Approval.
Outcome: The application is reviewed ahead of others. Approval rules do not change.
Legal basis: Pharmaceuticals and Medical Devices Act, Article 14(11) and Article 23-2-5(11); MHLW notice on priority review of 31 August 2020
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal, met in 80% of cases. About 9 months for priority new drugs approved in FY2026. For regenerative medical products, the priority target is about 9 months for 50 percent of products. This is an official performance target, not an actual review time. It counts total time from filing to approval, including the applicant's time. | 274 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, Fast priority review of a product already sold abroad during a supply shortage, Conditional approval, Pioneering product designation (SAKIGAKE), 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. See all routes on the or explore them in the .
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.