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
Applicable national legal framework/ Reference
Art 74-77 Law on MP & MD 2010
Art 40 Rulebook Application 2011
Additional Information
In case of incompleteness of the application, the sponsor has 30 days to submit the missing information/ documentation.
Some ECs have shorter internal timelines.
The EC is obliged to inform the sponsor and the national Agency within 15 days after the decision has been reached!
