Japan · Pharmaceuticals and Medical Devices Agency · Generics
Review target
304 days
performance goal
Legal time limit
-
Not published
Steps
4
8 requirements
Application fee
¥649,100
Rates in the fee order version in force from 2026-05-01
A generic prescription drug needs product approval like any other drug, but with a smaller data set. The agency checks quality and bioequivalence with the original product. Makers of prescription drugs must report planned supply stops. A prescription drug with the same active ingredient, route, dose and indication as an approved original drug.
The official review target is 304 days (performance goal, met in 70% of cases). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The pmda review fee, other prescription drugs including generics is ¥649,100 for Rates in the fee order version in force from 2026-05-01.
1. File the application through PMDA; 2. Review and compliance survey; 3. GMP inspection; 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).
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 70% of cases. About 10 months of agency time for new generic applications approved in FY2026. This is an official performance target, not an actual review time. It counts only the agency's own time, not the applicant's time. | 304 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| PMDA review fee, other prescription drugs including genericsApplication · Rates in the fee order version in force from 2026-05-01 | ¥649,100 |
| PMDA document compliance survey fee, other prescription drugs including genericsInspection · Rates in the fee order version in force from 2026-05-01 | ¥346,700 |
Other routes in Japan: Approval held by a foreign manufacturer through a designated marketing authorization holder. 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 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.