Germany · Paul-Ehrlich-Institut · Cell and gene therapy
Review target
-
Not published
Legal time limit
152 days
law
Steps
4
6 requirements
Application fee
€4,250
2026
Advanced therapy medicines that are prescribed as an individual preparation for one patient, are not made routinely, and are used in a specialised care institution under a doctor's responsibility do not need a marketing authorisation. They can be supplied to others only with an approval from the Paul-Ehrlich-Institut. The decision is due within five months, and the approval can be time-limited. Cell, gene or tissue engineered products made non-routinely for individual patients and used in a specialised hospital.
The § 4b approval: fee range 4,250 to 20,000 euros set by the work involved (amount shown is the minimum) is €4,250 for 2026.
1. Submit the approval application; 2. Assessment and decision (152 days); 3. Approval; 4. Periodic reports.
Outcome: A § 4b approval, which can be time-limited.
Legal basis: Arzneimittelgesetz (AMG) § 4b with § 21a
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 152 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
| Legal time limitlaw. About 5 months, with the clock stopped while deficiencies are fixed. This is an official target in the law, not an actual review time. | 152 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| § 4b approval: fee range 4,250 to 20,000 euros set by the work involved (amount shown is the minimum)Application · 2026 | €4,250 |
Other routes in Germany: Compassionate use programme. See all routes on the Germany 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 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.