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Important information on the transition of clinical trials to comply with the EU Regulation

7.12.2023 | Published in English on 13.12.2023 at 9.22

The transition period for the EU Regulation on clinical trials on medicinal products for human use (536/2014) is ending on 30 January 2025. Clinical trials that have been initiated in compliance with the Clinical Trials Directive and have at least one active centre after 30 January 2025 must undergo transition to comply with the EU Regulation, i.e. the transition must be approved by the authority, i.e. Fimea and Tukija, in the CTIS portal no later than 30 January 2025. 

Active centres are those sites where treatment or follow-up is taking place according to the protocol, either by contacting the patient from the site (e.g. by telephone) or by the patient physically coming to the site for a follow-up visit according to the protocol. If the monitoring is done according to the protocol so that only the registers provide the information, no transition is necessary.

The accelerated timetable for processing the application can be met if the transition application is submitted to the CTIS portal by 16 October 2024. Under the accelerated timetable, the processing time is 22 days if all the necessary documents have been submitted with the application. See the screenshot guide on how to make a transition to the CTIS portal (pdf). 

After the end of the transitional period of the EU Regulation, clinical trials may no longer be conducted in compliance with the directive. If the transition is not approved by 30 January 2025, but a clinical trial under the directive continues after that date, the trial will be deemed non-compliant. The authority will then have to intervene to prevent the continuation of non-compliant trials.

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