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The new EU Clinical Trial Regulation: Key considerations

LINK Medical is currently preparing to work in line with the Clinical Trial Regulation, going into effect on the 31st of January 2022.

The new regulation will replace the Clinical Trials Directive 2001/20/EC and aims to ensure a higher level of harmonization of the rules for authorizing and conducting clinical trials throughout the EU thus making it more attractive to conduct clinical trials in the EU. The new regulation goes into effect today, on the 31st of January 2022.

“The important point to consider is the submission of new long-term studies that will be started in 2022.”

Clinical studies can still be submitted according to the old Directive until January 2023, and studies that have already been submitted according to the old process can continue to be managed according to the old process until January 2025.

The important point to consider is the submission of new long-term studies that will be started in 2022, states LINK Medical, a full-service Nordic CRO. For those studies, it may be preferable to submit according to the new system because otherwise, they will have to be transferred into the new system in 2025. Short-term studies are not urgent, but applicants for future studies should be aware of this.

Key considerations to be aware of with the new Clinical Trial Regulation according to LINK Medical:

Submission process and assessment timelines

A single clinical trial application is submitted through the new EU Clinical Trial Portal, Clinical Trials Information System (CTIS) regardless of the number of participating member states. The assessment procedure is divided into two parts. While Part I is assessed by all participating member states and focuses on aspects of the trial that are the same for all member states e.g. the protocol and CMC information, Part II is assessed by each member state separately and focuses on local aspects of the trial, e.g. patient facing documents.

Associated with this single application are new timelines, worth mentioning is the maximum 12 calendar days timeline to respond to questions from member states during the Part I/II assessment – previously this timeline was up to 90 days in some member states.

Part I and II can be submitted and assessed in parallel, or instead only Part I can be submitted for assessment, and then Part II can be submitted within two years.

Increased reporting responsibilities

The CTR aims at increasing transparency for the general public. As part of this effort, more data points need to be reported through the portal. This means all stakeholders need to be prepared to make these data points available and report them accordingly.

Organizational preparations and training

Sponsors of clinical trials should prepare themselves and set up their organization accordingly in terms of user management and user roles.

Transition period

During the transition period from 31 January 2022 to 31 January 2023, clinical trial applications can be submitted according to the current national process in accordance with EU Directive 2001/20/EC or according to the EU Regulation 536/2014. Trials approved according to the Directive 2001/20/EC can continue to be conducted according to the Directive until 31 January 2025. After that, all ongoing trials should be transferred and conducted according to Regulation 536/2014.

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