Japan · Pharmaceuticals and Medical Devices Agency · Cell and gene therapy
Review target
365 days
performance goal
Legal time limit
-
Not published
Steps
5
4 requirements
Application fee
¥18,803,400
Rates in the fee order version in force from 2026-05-01
Processed human or animal cells and gene therapy products form their own product type, regenerative medical products. Each product needs approval from the health minister after PMDA review. Manufacturing quality is always checked before approval. Cell-based products processed by culture or other methods, and products with genes introduced into human cells for treatment.
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, regenerative medical product is ¥18,803,400 for Rates in the fee order version in force from 2026-05-01.
1. File the application; 2. Scientific review (365 days); 3. Manufacturing quality inspection; 4. Approval by the health minister; 5. Re-examination.
Outcome: Product approval. The product is then subject to re-examination after a set period.
Legal basis: Pharmaceuticals and Medical Devices Act, Article 2(9), Articles 23-20 and 23-25 to 23-29
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 standard regenerative products 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, regenerative medical productApplication · Rates in the fee order version in force from 2026-05-01 · Small and venture companies that meet set conditions can get half of PMDA consultation and application fees back for qualifying innovative devices, regenerative products and IVDs, under a government-funded program. | ¥18,803,400 |
| PMDA document compliance survey fee, regenerative medical productInspection · Rates in the fee order version in force from 2026-05-01 · Small and venture companies that meet set conditions can get half of PMDA consultation and application fees back for qualifying innovative devices, regenerative products and IVDs, under a government-funded program. | ¥1,476,200 |
| National fee to the government for approval, regenerative medical productApplication · Rates in the fee order version in force from 2026-05-01 | ¥100,000 |
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), Conditional and time-limited approval of a regenerative medical product, 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 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.