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').

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