Japan · Pharmaceuticals and Medical Devices Agency · Cell and gene therapy
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
3 requirements
Application fee
¥9,411,700
Rates in the fee order version in force from 2026-05-01
A regenerative medical product that is not uniform in quality can be approved early when efficacy is presumed and it is not presumed to be too harmful. The approval has conditions and a time limit of up to seven years, which can be extended by up to three years. The holder must file a new full application within the time limit. Cell or gene therapy products whose quality varies, where efficacy can be presumed from early data.
The pmda review fee, new application after conditional and time-limited approval is ¥9,411,700 for Rates in the fee order version in force from 2026-05-01.
1. File the application; 2. Pharmaceutical Affairs Council opinion; 3. Approval with conditions and a time limit; 4. Studies after approval; 5. New application within the time limit.
Outcome: Approval with conditions and a time limit of up to seven years. Valid for 7 years.
Legal basis: Pharmaceuticals and Medical Devices Act, Article 23-26
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 |
|---|---|
| PMDA review fee, new application after conditional and time-limited approvalApplication · Rates in the fee order version in force from 2026-05-01 | ¥9,411,700 |
Other routes in Japan: Approval held by a foreign manufacturer through a designated marketing authorization holder, Priority review, Pioneering product designation (SAKIGAKE), Orphan designation, Specific-use product designation, Emergency approval (time-limited), Approval of a regenerative medical product (cell or gene therapy), 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.