Japan · Ministry of Health, Labour and Welfare · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
-
In a health emergency, the minister can approve a drug set by cabinet order that is urgently needed, has no suitable alternative, and is allowed for sale in a listed country. Some normal review and inspection rules do not apply. The cabinet order currently covers drugs for COVID-19. An urgent outbreak or spread of health harm, where a drug already allowed for sale in the United States, the United Kingdom, Canada, Germany or France is needed and there is no other suitable option.
1. File the application; 2. Pharmaceutical Affairs Council opinion; 3. Special approval; 4. Post-approval measures.
Yes. It relies on approvals from Canada, Germany, France, United Kingdom, United States (reference approval required, reference approval required, reference approval required, reference approval required, reference approval required).
Outcome: Approval after hearing the council. The minister can require safety reports and other measures.
Legal basis: Pharmaceuticals and Medical Devices Act, Article 14-3; Enforcement Order Article 28
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, Emergency approval (time-limited), Combination products (drug, device or regenerative product). See all routes on the Japan page or explore them in the Regulatory section.
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 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.