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.
Demystifying EU CTR, MDR and IVDR
Download now and demystify the EU regulation process for medical devices, in vitro diagnostic devices and combined studies.
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.
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.
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.
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.
Latest on Regulatory Intelligence
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EU Clinical Trials Regulation blogs and media contributions
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Media article: Understanding EU regulatory requirements for studies with medical devices and in vitro diagnostic devices
2 page advertorial piece in the December 2024 edition of RAPS Quarterly In Focus Magazine
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Blog: Streamlining early phase clinical trial submissions under the EU CTR
The EU CTR represented a significant shift in the regulatory landscape, aiming to create a more favourable environment for clinical research across Europe.
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Blog: Integrating Performance Studies of In-Vitro Diagnostics into Clinical Trials: A Complex Challenge
We explore how to navigate the nuances of regulations and embrace collaborative initiatives to overcome challenges and unlock the full potential of combined trials.
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Media article: Essential considerations for a successful submission under EU CTR
Introduction of a single electronic portal, the Clinical Trial Information System (CTIS), which is mandatory for all EU CTR submissions.
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Blog: The impact of the new EU Clinical Trial Regulation on language translation
On January 31st, 2023, the EU Clinical Trial Regulation and the Clinical Trial Information System went live and changed the European landscape for clinical trials.
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Blog: Progressive IVDR rollout made official
In the fall of 2020, the European Commission issued a proposal to modify the implementation timeline for the new In Vitro Diagnostic Medical Devices Regulation (IVDR). Now, as of 15 December 2021, the European Parliament and the European Council have adopted this proposal, making the suggested progressive IVDR rollout timeline official.
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Media article: Overcoming IVDR challenges for companion diagnostics
Angela Brown and Nicole Cowan provide expert commentary on overcoming IVDR challenges for companion diagnostics.
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Media article: Assessing The Impact Of MDR & IVDR On Patients
In Diagnostics World's recent article featuring commentary from ICON experts David Novotny, Angela Brown and Nicole Cowan, they discussed the need to assess the impact of MDR/IVDR on patients after the new medical device regulation is established.
