Regulatory verification
How to verify whether a proposed cell therapy is lawful
There is no reliable country-wide yes/no answer. Status depends on the exact product, indication, processing, route, provider, manufacturing site and whether the use is authorised, part of a registered trial or otherwise permitted by national law.
Verification sequence
- Ask for the exact product name, indication, processing method and proposed route.
- Ask the provider to identify the competent authority and provide the current authorisation or trial number.
- Check the record directly in the authority or trial registry; do not rely on a clinic screenshot.
- Confirm the facility and manufacturing authorisations separately from the treatment status.
- Have an independent clinician or qualified regulatory professional review the result.
Starting points
- European Medicines Agency: advanced therapies
- US FDA: cellular and gene therapy products
- ClinicalTrials.gov
- WHO International Clinical Trials Registry Platform
Regulatory information changes. Verify the current record for the exact proposed treatment and jurisdiction.