The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial subjects.

Clinical Trial Application

A Clinical Trial Application provides comprehensive information about the investigational medicinal product(s) and planned trial, enabling regulatory authorities to assess the acceptability of conducting the study. Health authorities’ assessment covers the investigational medicinal product properties, the benefit/risk ratio of the study, the quality of the information provided to the trial subjects, and the suitability of the clinical sites and investigators.

CTA in the European Union

Clinical trials are currently regulated by Directive 2001/20/EC, which will be superseded by the Clinical Trial Regulation 536/2014, which was published on 27 May 2014 and will apply at the earliest on 28 May 2016. The Directive provides for the prior authorization from a Competent Authority (CA) and a positive opinion from a central Ethics Committee (EC) prior to the conduct of the trial in a given Member State. Additional committees/bodies may be involved, depending on the study and on the country concerned.

The content of the CTA for CAs and ECs is described in distinct EU detailed guidances, which have been more or less strictly implemented in the national laws. The structure and format of the CTA dossiers is country-specific; CTA dossiers do not follow the Common Technical Document (CTD).