ECSubmissionFee object
Fees for Ethical review mandatory
Yes
Waiver for academic (non-commercial) studies possible
No
Fees for Ethical review
Applicable fees (VAT included) from 01.01.2016:
Phase I-III: 1690 EURO
Phase IV: 768 EURO
Bioequivalence studies: 461 EURO
Amendments: 308 EURO
Non-interventional clinical trials: 310 EURO
Official guidance on required fees available
Yes
Official guidance on required fees
COMUNICAT privind tarifele CNBMDM incepand cu 01.01.2016;
(available on CNBMDM website in section "Comunicate" in Romanian only)