Japan · Pharmaceuticals and Medical Devices Agency · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
A company that makes a product abroad for export to Japan can hold the approval itself. It must appoint a licensed marketing authorization holder in Japan, which markets the product and takes safety measures in Japan. The review is the same as for a domestic application. A foreign maker that wants to hold the Japanese approval in its own name instead of transferring it to a Japanese company.
1. Appoint a designated marketing authorization holder; 2. File the application; 3. Review as for a domestic application; 4. Approval.
Outcome: Approval held by the foreign maker. The designated marketing authorization holder in Japan markets the product.
Legal basis: Pharmaceuticals and Medical Devices Act, Article 19-2 (drugs), Article 23-2-17 (devices and IVDs), Article 23-37 (regenerative medical products)
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 of a generic prescription drug, Approval of a biosimilar, Priority review, 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). 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.