The EU Clinical Trials Regulation’s transitional period

Cooley’s Productwise Bitesize brings you a short overview of the transitional provisions in the new Clinical Trials Regulation.

What is it called?

On 31 January 2022, Regulation (EU) 536/2014 on clinical trials on medicinal products for human use (the “Clinical Trials Regulation”) will become applicable in the EU. It will replace the Clinical Trials Directive (Directive 2001/20/EC) and the related national implementing legislation of individual EEA countries over a transitional period.

What is it about?

The Clinical Trials Regulation will impose a single set of rules governing many aspects of clinical trials conducted in the EU and introduce the Clinical Trials Information System (CTIS). It provides a single portal for applications for approval of clinical trials and, among others, introduces a single retention period for the Clinical Trial Master File and GCP documents of 25 years. The EEA countries have, until now, had national retention periods which could pose a challenge in terms of data management.

The Regulation includes a complex transitional period which is intended to assist sponsors to achieve compliance with the requirements imposed by the Regulation.

To whom and what does it apply?

The transitional period is applicable to sponsors of both future and of ongoing clinical trials in the EEA.

The Clinical Trials Regulation will apply to ongoing clinical trials with a hard cut-off date on 31 January 2025. By this date all clinical trials authorized under the Clinical Trials Directive must be conducted in compliance with the Clinical Trials Regulation. This means that related applications for authorization under the Clinical Trials Regulation must be submitted to the competent authority at the very latest by 30 November 2024. This is because the competent authority has up to 60 days to complete its review of the application.

Until 31 January 2023 Sponsors may initiate a new clinical trial in accordance with either the Clinical Trials Directive, or, the Clinical Trials Regulation. Clinical trials initiated during the transitional period in accordance with the Clinical Trials Directive will be subject to the later hard cut-off date of 31 July 2025. As a result, if these trials continue after 31 July 2025 they will be required to then comply with the Regulation.

Trials initiated and authorized prior to the Clinical Trials Directive, that were not transitioned to the Clinical Trials Regulation, cannot benefit from the transition period. If the clinical trial is still interventional and impossible to terminate for patient considerations, the Sponsor should have applied for authorization under the Clinical Trials Regulation by 30 November 2021.

Why does it matter?

Sponsors have a limited time frame to transition their Standard Operating Procedures or policies concerning conduct of clinical trials, informed consent forms and other regulatory documents to achieve compliance with the requirements of the Clinical Trials Regulation. Sponsors need to decide either to rely on the regime of the Clinical Trials Directive, or on the Clinical Trials Regulation, for new clinical trials initiated before 31 July 2023 . Sponsors also need to decide on the implications of any related decision for trials that will continue after 31 July 2025.

Where can I find it?

The Clinical Trials Regulation can be found here.

A Q&A on the Clinical Trials Regulation including its transitional provision is available here.

Article authored by Elisabethann Wright, Alexander Wenzel, Jessica Koffel

Posted by Cooley