What are the fees of clinical trial
registration in Poland?



Regulatory Agency Fees
Investigational Medicinal Product CTA submission fees
- Bioequivalence studies: 7 000 PLN (approx. 1 750 EUR or 2 500 USD)
- Phase I-III: 8 000 PLN (approx. 2 000 EUR or 2 850 USD)
- Phase IV: 4 000 PLN (approx. 1 000 EUR or 1 425 USD)

Medical Device CTA submission fees
- Initial submission: 5 000 PLN (approx. 1 250 EUR or 1 800 USD)
- Amendments: 1 500 PLN (approx. 375 EUR or 550 USD)

The submission fees should be wired to the below bank account number:

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa, Poland

Account No.: PL30 1010 1010 0094 1022 3100 0000
NBP BIC Code: NBPLPLPW
Bank: Narodowy Bank Polski, Plac Powstańców Warszawy 4, 00-950 Warszawa, Poland
For more information please click here.

The RA submission should be addressed to:
Centralna Ewidencja Badań Klinicznych
Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Al. Jerozolimskie 181C
02-222 Warszawa, Poland