Japan · Pharmaceuticals and Medical Devices Agency · Over-the-counter
Review target
365 days
performance goal
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
¥1,627,300
Rates in the fee order version in force from 2026-05-01
Non-prescription drugs need product approval. Products with an ingredient, route, indication, form or dose new to the non-prescription market, such as switches from prescription use, need more data and a longer review. Products that match an approval standard need little data. Pharmacist-guidance drugs and general non-prescription drugs, from a first switch of a prescription ingredient to simple products under an approval standard.
The official review target is 365 days (performance goal, met in 50% of cases). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The pmda review fee, non-prescription drug that differs from approved non-prescription drugs (for example a switch product) is ¥1,627,300 for Rates in the fee order version in force from 2026-05-01.
1. File the application through PMDA; 2. Review for new OTC categories (1) to (6) (365 days); 3. Review for categories (7) and (8) (213 days); 4. Approval by the health minister.
Outcome: Product approval from the health minister.
Legal basis: Pharmaceuticals and Medical Devices Act, 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).
About 365 days end to end with the official step targets. Targets, not actual times.
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 50% of cases. About 12 months for OTC categories 1 to 6 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, non-prescription drug that differs from approved non-prescription drugs (for example a switch product)Application · Rates in the fee order version in force from 2026-05-01 | ¥1,627,300 |
| PMDA review fee, other non-prescription drugsApplication · Rates in the fee order version in force from 2026-05-01 | ¥324,200 |
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 (16 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.