Cell-therapy due diligence for patients in Germany
A country-specific starting point for checking product authorisation, trial oversight and cross-border follow-up. This page does not rank providers or recommend medical travel.
What the regulator can confirm
The Paul-Ehrlich-Institut is Germany's competent authority for advanced therapy medicinal products. Its records distinguish centrally authorised ATMPs, authorised clinical trials and the narrowly defined national hospital-exemption route. A provider's location in Germany, a medical-facility licence or a general reference to German standards does not prove that each offered cell or secretome intervention is authorised.
Ask for the product name, classification, manufacturer, indication and the specific PEI, EMA or trial record. If a provider relies on a hospital exemption or another special route, request the authority, scope, named product and current validity. Compare the proposal with established care and obtain independent specialist advice.
Evidence to request before treatment
| Question | Document or identifier | Why it matters |
|---|---|---|
| What exactly is administered? | Product name, cell source, processing, dose and route | Evidence and legal status are product- and indication-specific. |
| What is the legal route? | Marketing authorisation, authorised trial number, or named exemption and authority | A clinic licence or registry listing does not by itself authorise a product. |
| Who manufactures it? | Legal manufacturer, site and authorisation scope | General references to GMP are not a substitute for a current, applicable record. |
| How are harms managed? | Consent form, adverse-event plan, insurance and emergency contact | Experimental status does not remove the duty to disclose and manage risk. |
| What happens after travel? | Written follow-up plan and named clinician | Cross-border care can complicate continuity and reporting. |
Conditions compared
Educational regulatory orientation, reviewed in 2026. Verify current records directly with the authority and seek independent medical advice.