On 31 January 2022, the new EU Clinical Trial Regulation (CTR) entered into force, replacing the previous Clinical Trial Directive (CTD). The new regulation requires that all clinical trial applications and assessments be managed through a new, unified online portal known as the Clinical Trial Information System (CTIS). Since January 2023, all new applications for clinical trials must be submitted under this new framework. For existing trials authorised under the CTD, a transitional period is currently in place: these trials must all have transitioned to the CTR by 30 January 2025, if the trial is likely to be ongoing beyond this date.
The European Medicines Agency (EMA) has recently issued advice to all sponsors transitioning trials in this context to submit their applications with sufficient time to spare prior to this deadline of January 2025. Sponsors are strongly advised to take into account the assessment time that will be required to complete the authorisation process set out by the European Commission, and should be aware that this can take up to 106 days.
The EMA estimates that fewer than 400 of these trials have been transitioned to date, out of an estimated total of between 4,000 and 6,000.
Read the advice of the EMA in full here.
Learn more about the process for transitioning trials here.
The National Office team is available to answer any questions you may have on the transitioning of trials from CTD to CTR; contact us at clinicaltrials@nrec.ie