Japan · Pharmaceuticals and Medical Devices Agency · New drugs
Review target
365 days
performance goal
Legal time limit
-
Not published
Steps
6
10 requirements
Application fee
¥36,538,400
Rates in the fee order version in force from 2026-05-01
A drug with an active ingredient that is not in any approved drug needs product approval from the health minister. The agency PMDA reviews the full quality, nonclinical and clinical data. Vaccines and other biologics follow the same route. A medicine whose active ingredient is not contained in any drug already approved in Japan or listed in the Japanese Pharmacopoeia.
The official review target is 365 days (performance goal, met in 80% of cases). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The pmda review fee, new active ingredient drug is ¥36,538,400 for Rates in the fee order version in force from 2026-05-01. A reduced fee of ¥30,618,800 applies in some cases (Lower fee for designated orphan drugs).
1. File the application through PMDA; 2. Scientific review and compliance survey; 3. GMP inspection; 4. Pharmaceutical Affairs Council opinion; 5. Approval by the health minister; 6. Re-examination after a set period.
Outcome: Product approval from the health minister. The product is then subject to re-examination after a set period.
Legal basis: Pharmaceuticals and Medical Devices Act (Act No. 145 of 1960), Article 14
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
| Review targetperformance goal, met in 80% of cases. About 12 months for standard new drugs approved in FY2026. This is an official performance target, not an actual review time. It counts total time from filing to approval, including the applicant's time. | 365 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| PMDA review fee, new active ingredient drugApplication · Rates in the fee order version in force from 2026-05-01 · Lower fee for designated orphan drugs. | ¥36,538,400reduced ¥30,618,800 |
| PMDA document compliance survey fee, new active ingredient drugInspection · Rates in the fee order version in force from 2026-05-01 · Lower fee for designated orphan drugs. | ¥10,363,300reduced ¥5,191,600 |
| National fee to the government for approval, new active ingredient drugApplication · Rates in the fee order version in force from 2026-05-01 | ¥533,800 |
Other routes in Japan: 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), 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 (24 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.