EU Clinical Trials Regulation: Impact on sites and sponsors

The European Union Clinical Trials Regulation (EU CTR) 536/20141 came into force on 31st January 2022, with a three-year phased transition period ending 31st January 2025. The EU CTR replaces the EU Clinical Trials Directive 2001/20/EC and the Voluntary Harmonisation Procedure.


A primary feature of the EU CTR is the introduction of a single electronic portal, the Clinical Trials Information System (CTIS), which is mandatory for all EU CTR submissions effective 31st January 2023. CTIS is the single-entry point for submitting, assessing, authorising, supervising, and reporting a clinical trial in all Member States of the EEA and provides harmonised and simplified end-to-end electronic application procedures over the lifecycle of clinical trials across the EU/EEA.

At ICON, we have updated our processes, working practices, and systems to ensure we adhere to the EU CTR and meet the respective timelines. We have optimised our workflows through our understanding of the requirements and the knowledge gained over the past 18 months. Training has been rolled out to all key stakeholders within our organisation, and we continue to work with our sponsors and sites to support their implementation needs. This enables ICON to proactively address challenges and mitigate risks at the time of submissions. To learn more, please contact us.  

Update: EU Clinical Trials Regulation

The European Union Clinical Trials Regulation 536/2014 (EU CTR) introduces fundamental changes for interventional clinical trial submissions and approvals in all 30 countries of the European Union and the European Economic Area. The EU CTR has established a harmonised approach for clinical trial applications, assessment and reporting with consistent rules. Read the updated whitepaper to understand the impact and strategic considerations for sponsors as well as experiences and lessons learned since the regulation went into effect.

Read the updated whitepaper

EMA guideline on computerised systems and electronic data in clinical trials

This whitepaper provides an overview of the evolution of the new EMA guideline on computerised systems and electronic data, its scope, and its impact.

Read the whitepaper

Navigating the new EU CTR in early phase clinical trials

During this webinar we outline the EU CTR regulatory review process in Europe– identifying the key differences and implications for your early phase study, outlining the efficiencies achieved within the EU CTR and Netherlands regulatory framework, and submission lessons learned and timeline to approval data based on our experience so far.

Watch the webinar

Procedural and regulatory know-how for China biotechs in the EU

In this white paper, ICON’s experts outline potential regulatory strategies and interaction plans for sponsors in China as a guide for marketing authorisation applications in the centralised procedure to the EMA, which allows the marketing authorisation holder to market a drug product in all European Union (EU) Member States, in addition, specific countries in European Economic Area (EEA), with a potential patient pool of approximately 500 million people. 

Read the whitepaper

Latest on Regulatory Intelligence

If you would like to receive our regulatory email updates, including the latest on regulatory information please visit our Preference Centre webpage and select Regulatory Updates under Value Based Development.

Receive Regulatory Intelligence email updates