Italian Medicines Agency Agenzia Italiana del Farmaco

EU Regulation on Clinical trials

EU Regulation on Clinical trials

The Clinical Trials evaluation system in Europe is facing a radical change starting from 31 January 2022, with the full application of Regulation (EU) no. 536/2014.

From that date, a one-year transition period began. During this period applications for authorization of clinical trials pursuant to Directive 2001/20/EC may still be submitted, on a voluntary basis. After this transition period, this possibility will not be applicable, together with the relevant national regulations, for all new trials. Within the next three years all ongoing trials will transition to the new requirements under the EU Clinical Trial Regulation (CTR).

With the application of the CTR, the European Union pursues the aim of increasing efficiency in clinical trials, especially in case of trials carried out in several Member States, stimulating innovation and research while limiting duplication of assessment and repetitions of trials with no added value.

The goal of the CTR is to create an environment favourable to conducting clinical trials in the EU by harmonizing the assessment and supervision rules and processes of clinical trials, while guaranteeing the highest standards of safety for participants and the transparency of information, through the publication of all information concerning the authorization, conduct and results of each clinical trial carried out in Europe.

With regard to the latter issue, and in order to increase the transparency of information on clinical trials, a dedicated portal has been developed for the management of all clinical trials in Europe (Clinical Trials Information System, CTIS), which will be fundamental to enhance transparency and strengthen collaboration, information exchange and decision-making processes between and within Member States.

The authorization and supervision of clinical trials will remain under the responsibility of the Member States, while the EMA will manage the CTIS and the publication of its contents in the public section of the portal.

To support the understanding and application of the CTR by all the involved parties, AIFA publishes useful information and relevant documents on this webpage.

However, it is recommended to refer to the guidance and training documents drawn up by the European Commission and EMA in collaboration with the experts of the National Medicine Agencies, accessible in the relevant documents and links.

For all national questions relating to the application of Regulation (EU) no. 536/2014, AIFA has made available an e-mail box with the following address:

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