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.
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EU Clinical Trials Regulation blogs and media contributions
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Media article: Regulatory bottlenecks mean EU clinicians & patients could lose access to medical devices under new rules
A recent press release by Samedan LTD Pharmaceutical Publishers on ICON’s scheduled presentation to be given at The Medtech Conference 2019, ‘MDR/IVDR – What now?’, during which our experts will discuss the findings of the whitepaper ‘Higher Costs & Bottlenecks’, looking at the future implications of the new MDR/IVDR rules on the EU market.
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Blog: A New Reality: EMA Published First Guidance on New MDR/IVDR Rules for Certain Devices
EMA recently published the first of a series of guidance documents to help applicants prepare for obligations enforced by new EU regulations on medical devices.
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Blog: EU CTR: Practical experiences and lessons learned
EU CTR effective January 31, 2022, introducing new age for interventional clinical trial applications in EU and EEA. Read more about the practical experiences and lessons learned.
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Blog: MDR / IVDR Regulatory Roundup
Less than one year remains before the European Union’s new Medical Device Regulation (MDR) goes into effect on May 26, 2020, and only about a fourth of medical device companies plan to be fully complaint,
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Blog: The Need for New Business Models under MDR/IVDR
The new MDR/IVDR will go into effect in 2020, greatly increasing the complexity of keeping existing products on the market and introducing new ones.
