Regulatory Dashboard | ACT NOW: EMA Urges Timely Submission for CTR Transition

The transition clock is ticking as the January 2025 deadline approaches, with approximately 70% of ongoing clinical trials still needing to be transitioned from the Clinical Trial Directive (CTD) to the Clinical Trial Regulation (CTR). The European Commission (EC) and Member States (MSs) strongly advise transitioning before the 16th of October 2024 to take advantage of the expedited procedure agreed by the Clinical Trials Facilitation Group (CTCG).

Sponsors are reminded to take advantage of the expedited transition lasting until October 16, 2024. Beyond that date, there is an increased risk of missing the time window, given that the legislative timeline could extend up to 106 days, potentially leading to a halt in the clinical trial. Any resulting penalties would fall under national regulations.


For further assistance in implementing the regulatory requirements for transitioning from the CTD to the CTR, consider reaching out to Ergomed. With their expertise in regulatory insight and practical experience, they can provide valuable support and guidance.

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