Japan · Ministry of Health, Labour and Welfare · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
3 requirements
Application fee
-
A drug, device or IVD with a high medical need, such as an orphan or pioneering product, can be approved when its efficacy can be reasonably predicted. The approval requires studies after approval. The holder files the results and the minister checks the product again. Orphan, pioneering, specific-use or other high-need products where efficacy can be reasonably predicted but has not yet been fully confirmed.
1. File the application; 2. Review; 3. Pharmaceutical Affairs Council opinion; 4. Conditional approval; 5. Studies after approval and re-check.
Outcome: Approval with conditions, including studies after approval. The conditions can be changed, and the studies can be ordered again.
Legal basis: Pharmaceuticals and Medical Devices Act, Article 14-2-2 (drugs) and Article 23-2-6-2 (devices and IVDs), as revised by Act No. 37 of 2025
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, Pioneering product designation (SAKIGAKE), Orphan designation, Specific-use product designation, Special approval for emergencies (based on foreign approval), Emergency approval (time-limited), 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 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 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.