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
Xenogeneic cell therapy: Timespan (max nr days)
Not specified
Clock-stop possible if complementary information requested
Yes
Timespan counted from
Date of submission of valid application
National legal framework in place
Yes
Applicable national legal framework/ Reference
41(a) AMG
Additional Information
Meetings are monthly with set deadline dates for submission, which is usually about 3 weeks prior to the meeting. The general reviewing timeline is 60 days from day of submission or 35 days from submission deadline (Art 41a(5&6) AMG.
An objection can be raised by the competent authority, which can also approve trials in case a negative opinion is made by the EC (by means of introduction of an 'Arzneimittelbeirat').