The face of clinical trials in the European Union (EU) is changing. By January 31, 2025, all ongoing clinical trials must move to the Clinical Trials Information System (CTIS). This date will mark the end of a three-year transition period, which started when the EU Clinical Trial Regulation 536/2014 (EU-CTR) became effective on January 31, 2022.
The new regulations are designed to simplify and streamline the clinical trial approval and management process in the EU and European Economic Area (EEA) and overcome limitations and challenges associated with the EU Clinical Trial Directive 2001/20/EC (EU-CTD), which has governed clinical trials since 2004.
One important difference is that the CTIS will function as the sole point of entry for clinical trial information across the EU and the EEA. This blog will review the transition timeline, the benefits of the new system, potential challenges for sponsors and how sponsors can prepare to keep their clinical trials on track.
Timeline of Transition
Critical dates for the transition are as follows:
- January 31, 2022 to January 31, 2023: Sponsors had the option to submit clinical trials under the legal framework of EU-CTD or EU-CTR.
- Starting January 31, 2023: All clinical trial applications are subject to EU-CTR. Trials approved under EU-CTD before January 31, 2023, can continue to be regulated under EU-CTD until January 31, 2025.
- January 31, 2025 and beyond: All clinical trials will be regulated under EU-CTR.
Authorities plan to review the EU-CTR every five years to ensure it achieves its intended results.
Benefits of the Centralized Electronic Database: CTIS
The centralized CTIS is the primary clinical trial information resource and communication tool for sponsors, EU member states, EEA countries and the European Commission. Sponsors can use the CTIS to apply for authorization to run a clinical trial in up to 30 EEA countries via a single online application. In addition, the CTIS offers a searchable public website that allows the public to research clinical trial information. Data and documents submitted through CTIS will be publicly available on a standardized timeline for authorized or refused trials.
Challenges for Sponsors
While EU-CTR promises significant benefits, clinical trial sponsors will face challenges adapting to the new system. Using the CTIS and complying with new regulations may require sponsors to adjust their operational systems and workflows. For example, sponsors will have stricter timelines for responding to application queries. Under the new rules, sponsors must reply to any application queries or requests for information from member states within 12 days, or the application will lapse and need to be re-submitted. To meet these requirements, sponsors may need to identify dedicated resources that will be responsible for the collection and ongoing submission of data into CTIS.
How Can Sponsors Prepare?
Sponsors must take steps now to address the changes and prepare for the transition to EU-CTR and the CTIS. Impact analysis is crucial to understanding how the new rules affect current processes. System enhancements may be necessary to track compliance with regulations and accommodate new requirements. Updates to standard operating procedures, work instructions, and training materials will ensure that staff are well-equipped to navigate the changes effectively. A proactive approach will help sponsors avoid costly delays and ensure their trials remain on track.
Embracing Change: Implementation Considerations
The transition to EU-CTR represents a significant shift in the EU clinical trial landscape. While it presents challenges for sponsors, it also offers opportunities to streamline processes and enhance transparency. By preparing effectively and embracing change, sponsors can navigate the transition successfully and contribute to the advancement of clinical research in Europe. As a reliable and experienced clinical trials partner, QPS can support sponsors throughout the transition. Our experts can help with many important transition responsibilities, including the following:
- Redaction and deferral strategy
- Uploading Part 1 and Part 2 documentation into CTIS
- Compiling, validation and substantial modification management
- Gap analysis of existing documentation to ensure compliance with regulatory requirements
- Training on CTIS and drafting of supporting CTIS standard operating procedures
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