Japan · Ministry of Health, Labour and Welfare · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
4 requirements
Application fee
¥30,618,800
Rates in the fee order version in force from 2026-05-01
The health minister designates drugs, devices and regenerative products for diseases with fewer than 50,000 patients in Japan and a high medical need. Designated products can get grants, guidance, a tax credit, priority review, lower review fees for drugs, and a 10 year re-examination period for drugs and regenerative products. A product for a disease with fewer than 50,000 patients in Japan, with a high medical need and a realistic development plan.
The pmda review fee, new active ingredient drug with orphan designation is ¥30,618,800 for Rates in the fee order version in force from 2026-05-01.
1. Designation consultation with the ministry; 2. File the designation application; 3. PMDA pre-evaluation; 4. Pharmaceutical Affairs Council review; 5. Designation.
Outcome: Designation after review by the council. Designation does not mean the product will be approved.
Legal basis: Pharmaceuticals and Medical Devices Act, Articles 77-2(1), 77-3 and 77-4
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).
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 |
|---|---|
| PMDA review fee, new active ingredient drug with orphan designationApplication · Rates in the fee order version in force from 2026-05-01 | ¥30,618,800 |
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), 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.