The pharmaceutical industry faces a critical deadline as companies must transition their ongoing European Union clinical trials from the Clinical Trials Directive to the new Clinical Trials Regulation (CTR) by January 30, 2025. Failure to meet this deadline could result in companies losing their legal basis for conducting trials in the EU.
Transition Timeline and Requirements
The transition period, which began in January 2022, requires companies to transfer their trial dossiers into the Clinical Trial Information System (CTIS), the new centralized platform for managing clinical trial-related regulatory processes. With the review process taking up to 106 days and additional time needed for compliance preparations, organizations must act swiftly to ensure successful transition.
Harmonization of Trial Documentation
A key requirement of the transition is the creation of a harmonized dossier across all participating EU member states. The core dossier, known as Part I, must be standardized and includes critical documents such as:
- Clinical trial protocol
- Investigator's Brochure (IB)
- Investigational Medicinal Product Dossier (IMPD)
Companies can choose between two transition approaches:
- Expedited transition with minimal documentation
- Full transition with comprehensive CTD-approved documentation
Administrative Framework and CTIS Implementation
Organizations must select between two management models for CTIS implementation:
- Organization-centric approach:
- Recommended for companies planning multiple EU studies
- Requires a high-level administrator
- Demands complex setup and registration in the Organisation Management Services (OMS)
- Trial-centric approach:
- Suitable for smaller companies and academic institutions
- Less resource-intensive
- Easier to outsource to service providers
Critical Considerations and Challenges
Several factors are complicating the transition process:
- Ongoing regulatory processes must be completed before transition
- Multiple-country trials face coordination challenges
- Health authorities and ethics committees are experiencing resource constraints
- System updates and personnel adjustments are causing longer review times
Preparation for CTR Compliance
Once transitioned, any substantial modifications to trials will require full CTR compliance. Organizations must:
- Update both Part I and Part II documentation to meet new standards
- Ensure product details are current in the EudraVigilance medicinal product dictionary
- Maintain connections between all trial organizations within CTIS
- Monitor ongoing regulatory guidance from multiple European authorities
The transition represents a significant regulatory shift in European clinical trial management, requiring careful planning, resource allocation, and strategic decision-making from pharmaceutical companies and research organizations.
