The transition period for the EU Regulation on Clinical Trials on medicinal products for human use (CTR, 536/2014) is approaching its conclusion, with a final deadline set for January 30th, 2025.
To facilitate a smooth transition, the Clinical Trials Coordination Group (CTCG) is offering an expedited procedure for multinational trial applications. This procedure allows for the rapid validation of Clinical Trial Document (CTD) authorized documents, potentially reducing the approval timeline to as little as 22 days, provided there are no Requests for Information (RFIs). The approval process consists of a 10-day validation phase, followed by a 7-day assessment phase, and concluding with a 5-day decision period. However, in cases where RFIs are issued, the maximum timeline may extend up to 37 days.
It is important to note that the expedited transition procedure will only be available until October 16th, 2024. After this date, the feasibility of this accelerated procedure may be impacted by the workload and other factors.
At Asphalion, we specialize in the Clinical Trials Information System (CTIS) and can partner with you to successfully navigate the transition to the Clinical Trials Regulation (CTR). Our expertise ensures that your clinical trials will adhere to the new regulations while minimizing delays.
For more information on how we can support you during this critical transition, please do not hesitate to contact us: [email protected]
