Japan · Ministry of Health, Labour and Welfare · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
3 requirements
Application fee
-
In a health emergency, the minister can approve a drug set by cabinet order when efficacy is presumed and the drug is urgently needed with no suitable alternative. The approval has conditions and a time limit of up to two years, which can be extended by up to one year. The holder must file a new full application within the time limit. An urgent outbreak or spread of health harm, where confirmatory data are not yet complete but efficacy and safety can be presumed.
1. File the application; 2. Pharmaceutical Affairs Council opinion; 3. Approval with conditions and a time limit; 4. Studies and reports; 5. New application within the time limit.
Outcome: Approval with conditions and a time limit of up to two years. Valid for 2 years.
Legal basis: Pharmaceuticals and Medical Devices Act, Article 14-2-2-2 (drugs) and Article 23-26-2 (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 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, Specific-use product designation, Special approval for emergencies (based on foreign approval), 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.