Informational page about registering clinical trials in Poland
Regulatory Agency/Competent Authority (RA) and Ethics Committee (EC) approval is required prior to any new drug or non-CE marked medical device clinical trial initiation in Poland. The Clinical Trial Application (CTA) should be submitted to the RA by the clinical trial sponsor or its authorized representative. Before the CTA is filed to the RA and EC, all non-EU sponsors must appoint a so-called ‘Legal Representative’ that has to be legally established in the European Union.
Application for drug studies can be made to RA and EC in parallel, however, the CTA for medical devices must be made to the RA after EC approval has been obtained. If the study drug or the medical device will be imported from a non-EU country, then an import license is required from the RA.
A decision on a valid request for authorization of clinical trials involving general medicinal products or medical device trials will be given within 60 days of receipt. Usually within 1-2 weeks of the study drug CTA submission the RA sends a confirmation letter informing that the 60-day approval period has been started.
After that time the applicant of the submission will usually be notified in writing of the acceptance or, if no correspondence documenting non-acceptance or acceptance subject to specified conditions is received, the trial can be considered authorised. Where notification of grounds for non-acceptance is made, the sponsor will have 14 days in which to respond with an amended request for further consideration. The final decision will be given within 60 days of receipt of the original request.
All application fees must be paid before the RA/EC submission is made and the submission fees depend on the type and phase of the study.
Investigational Medicinal Product CTA submission fees:
- Bioequivalence studies: 7000 PLN (approx. 1750 EUR or 2500 USD)
- Phase I-III: 8000 PLN (approx. 2000 EUR or 2850 USD)
- Phase IV: 4000 PLN (approx. 1000 EUR or 1425 USD)
Medical Device CTA submission fees:
- Initial submission: 5000 PLN (approx. 1250 EUR or 1800 USD)
- Amendments: 1500 PLN (approx. 375 EUR or 550 USD)