Last opportunity for expedited administrative procedure for handling a transitional clinical trial

From 31 January 2025, the Clinical Trial Regulation (CTR, EU no 536/2014) will apply to all clinical trials with a medicinal product. All ongoing clinical trials should have CTR approval prior to this date. If not, the clinical trial could be put on hold. 29 January is the deadline for requesting an expedited administrative procedure. 

From 31 January 2025, the sponsor of ongoing clinical trials without CTR approval must submit a completely new clinical trial application for approval in CTIS according to CTR rules. The CCMO or MREC may decide to take a corrective measure under Article 77 of the CTR, i.e. they can decide to withdraw the WMO approval previously given, put the clinical trial (temporarily) on hold or request the sponsor to submit a substantial modification.

The decision to take corrective action will be assessed on a case-by-case basis. Should the CCMO or MREC decide to do so, the sponsor and/or investigator will be given the opportunity to make their views known within one week.

The sponsor and/or investigator of ongoing clinical trials without CTR approval on January 2025 is requested to contact the CCMO at ctr@ccmo.nl so that the appropriate procedure can be initiated.
 

For more information: Transition trials: CTD to CTR