ECGeneralEthicalReview object
Submission for Ethical review mandatory for
Clinical IMP trials
Clinical ATMP trials
Submission to CA and EC to be performed in the following order
In parallel
Sequentially (in any order)
Additional Information
Royal Decree 1090/2015
According to thIS Decree, only the accredited ethics committees as CEIms - Committees on Ethics of Research with Medicines - are authorized to evaluate the clinical trials with medicinal or healthcare products.
Submission to the EC and CA can be done in any order or simultaneously (depending on the Sponsor’s preference).
NB! CA authorization is only possible provided that the EC’s favourable opinion has been issued before the deadline.
The Sponsor can select the EC for the evaluation for the CT. There will be only one EC that will do a unique CT evaluation.
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)
Ethics committee(s)
