ECTimelinesEthicalReview object
General timespan for single-centre studies (max nr days)
30
General timespan for multi-centre studies (max nr days)
30
ATMP/GMO trials (max nr days)
50
External expert advice required: Timespan (max nr days)
100
Xenogeneic cell therapy: Timespan (max nr days)
No time limit
Clock-stop possible if complementary information requested
Yes
National legal framework in place
Yes
Additional Information
The given timelines also apply to any designated ECs.
In most cases, requests for permission to conduct clinical trials are answered by INFARMED, CEIC, and CNPD within 60 days, if the applications are submitted concurrently.
NB! Hospital administrations may delay the approval even after receiving authorization from INFARMED/ CEIC/ CNPD because of several internal requirements.
