Japan · Ministry of Health, Labour and Welfare · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
3 requirements
Application fee
-
The health minister can designate a product for diseases in categories the minister sets, where demand for such products is far from met and the product would be especially useful. Designated products can get priority review and can qualify for conditional approval. A product for a disease in a category set by the minister, where products for that use are clearly lacking.
1. Apply for designation; 2. Pharmaceutical Affairs Council opinion; 3. Designation and public notice.
Outcome: Designation, publicly announced.
Legal basis: Pharmaceuticals and Medical Devices Act, Article 77-2(3), Article 14(11) and Article 14-2-2
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
| No time targets published. |
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, Pioneering product designation (SAKIGAKE), Orphan 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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.