This issue provides updates from the European Medicines Regulatory Network (EMRN), focusing on progress under the Accelerating Clinical Trials in the EU (ACT EU) initiative and ongoing enhancements to the Clinical Trials Information System (CTIS).
Key Highlights
1. ACT EU & Clinical Trial Innovation
- The outcome report from the October 2025 ACT EU multi‑stakeholder platform meeting is now available.
- Over 500 stakeholders across the clinical research ecosystem discussed how innovation can reshape clinical trials for patients.
- Core themes included:
- Patient‑centred research
- Evolving trial methodologies
- Biotechnology and artificial intelligence
- Digitalization
- Ethics
- Insights from the meeting will inform revisions to the ACT EU workplan, ensuring alignment with stakeholder needs and emerging opportunities.
2. HMA / CTCG Updates
- FAST‑EU pilot:
- 15 expressions of interest were received for the March submission slot.
- FAST‑EU aims to provide shorter evaluation timelines for selected multinational trials via CTIS.
- CTCG Workplan 2026–2027 published:
- Outlines objectives, initiatives, and strategic priorities.
- Confirms the group’s continued role in ACT EU implementation.
3. CTIS System Updates
- New mandatory requirement for Substantial Modifications (SMs):
- When requesting an extension of more than two years for trial start or restart, sponsors must now enter a Recruitment Start Date and/or Restart Trial Date for at least one Member State Concerned.
- Additional CTIS improvements include:
- Ability to submit new SMs when previous SMs involved a lapsed or withdrawn Member State.
- Enhanced handling of safety notifications (serious breaches, urgent safety measures, inspections) for halted trials.
- Ability to change the primary sponsor via SM Part I for trials that are ended or revoked.
- Role assignment delays:
- Due to EMA account infrastructure changes, CTIS role assignments may take up to 30 minutes to become fully active.
4. Related Regulatory Systems
- Updated XEVMPD interface (XEVMPDweb) is now available.
- The legacy interface will remain accessible until 10 May 2026.
5. Training & Events
- Upcoming CTIS sponsor training, system demos, and SPOR/XEVMPD webinars are announced to support sponsor preparedness and awareness of system modernization.
Document Source: Clinical Trials Highlights issue 30 - February 2026.pdf
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