ECTimelinesEthicalReview object
General timespan for single-centre studies (max nr days)
60
General timespan for multi-centre studies (max nr days)
60
ATMP/GMO trials (max nr days)
90
External expert advice required: Timespan (max nr days)
+ 90
Xenogeneic cell therapy: Timespan (max nr days)
No time limit
Clock-stop possible if complementary information requested
Yes
Timespan counted from
Date of submission of valid application
+ Payment of submission fees
National legal framework in place
Yes
Applicable national legal framework/ Reference
Art 29-31 Ordin nr. 904/2006
Regulament de functionare al CNBMDM
(available on CNBMDM website in section "About us" (Useful documents)
