Assessment & Approval

EU regulatory landscape

Prior to the implementation of the Clinical Trials Regulation (EU No. 536/2014), clinical trials in the EU were governed by EU directives (2001/20/EC, 2005/28/EC) and national laws, with variability across Member States (MS). In 2022, the Clinical Trials Regulation (CTR) became mandatory in all MS, repealing the Clinical Trials Directive (CTD) and national implementing of legislation. However, Part II of the Clinical Trial Application (CTA) is still authorised and supervised at national levels, leading to variability in the implementation of clinical trial elements across MS.

Recommendations

Harmonised implementation of all regulations from health authorities and ethics committees across the EU is needed. National-level variation hampers the conduct of CTs in a uniform way and requires tailored approaches in each country). A centralised overview of national-level variations, such as the HMA EMA Recommendation Paper on Decentralised Elements in Clinical Trials, should be regularly updated to provide support.

As for any complex or non-standard trial, engaging with regulators early in the trial design process is crucial for the successful implementation of DCTs.

Federal systems may influence which DCT approaches can be implemented in a country, regardless of CTA approval.

How Trials@Home reached these recommendations

We selected eleven EU MS for regulatory mapping, based on the number of registered clinical trials and geographical representation. The mapping included collecting documentation from the EMA and National Competent Authorities, focusing on laws and regulations relevant to DCTs.  The results showed gaps and a lack of alignment in several areas.

Further reading

Publications

COVID‐19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union.

de Jong, et al
Clinical Pharmacology & Therapeutics
2021
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Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective.

de Jong, et al
Clinical Pharmacology & Therapeutics
2022
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View poster

Direct-to-Participant Investigational Medicinal Product Supply in Europe – Experiences from Sponsors, Site Study Staff, and Couriers.

de Jong, et al
British Journal of Clinical Pharmacology
2023
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Layman version

Regulatory readiness to facilitate the appropriate use of innovation in clinical trials: the case of decentralized clinical trial approaches.

de Jong, et al
Drug Discovery Today
2024
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Deliverables

Map of the EU legislation on DCTs including legal, regulatory, ethical and stakeholder recommendations for conduct of the pan-EU pilot.

WP EAGLE, 2022
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Final EAGLE report.

WP EAGLE, 2025
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