1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape applicable in the EU/EEA in relation to Decentralized Clinical Trials (“DCT”) through the European Medicines Agency (“EMA”) and the Clinical Trials Regulation (EU) No 536/2014 (“EU CTR”), which came into effect in January 2022. From 31^st January 2023, clinical trial sponsors need to apply to start a clinical trial via the Clinical Trials Information System (CTIS). From 31s Jan 2025, any ongoing trials approved under the provisions of the Clinical Trials Directive 2001/20/EC (“CTD”), will need to comply with the CT Regulations, as described in this guidebook.

(In this Guidebook, we refer to various EU regulations, directives, guidelines and draft guidelines. An EU Regulation is a legal act that applies directly at the national level. When an EU regulation enters into force, it becomes directly and immediately applicable within EU Member States (countries), as well as in the EEA (EU + Norway, Iceland and Liechtenstein). Member states do not need to create their own legislation to bring this EU legal act into force. On the other hand, an EU directive is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals. As for EMA guidelines, these are intended to provide guidance on the scientific or regulatory aspects of the development of medicines and applications for marketing authorizations. Although guidelines are not legally binding, applicants need to provide justification for any deviations.)