CATimelineAuthorisation object
General timespan (max nr days)
30
Mode of approval (General)
Explicit
ATMP/GMO trials (max nr days)
30
Mode of approval (ATMP/GMO trials)
Explicit
External expert advice required (max nr days)
+ 90
Xenogeneic cell therapy (max nr days)
Not specified
Timespan counted from
Date of receipt of valid application
National legal framework in place
Yes
Applicable national legal framework/ Reference
Part 3, Section 18-20 of the Medicines for Human Use (Clinical Trials) Regulations 2004
Additional Information
Applications for healthy volunteer trials and sponsor-determined phase I trials in non-oncology patients may qualify for a shortened assessment time (average 14 days). You should state on your covering letter if you think your trial is eligible.
