Date of Publication: 26-Mar-2026
INTELLIGENCE OVERVIEW
Agency: EMA
The European Medicines Agency has published a new Clinical Trial Information System (CTIS) Sponsor Frequently Asked Questions (FAQs) document to help sponsors navigate common operational and regulatory challenges in CTIS. Released on 26 March 2026, this guidance complements the Sponsor Handbook and addresses recurring questions raised through CTIS support channels and sponsor interactions.
The new FAQ document provides practical clarification across the full clinical trial lifecycle, including pre-submission activities, clinical trial application preparation, evaluation timelines, trial conduct, safety reporting, end-of-trial notifications, results submission, and clinical study report (CSR) handling. It is particularly useful for sponsors, CROs, academic institutions, and other organisations managing trials under the EU Clinical Trials Regulation (CTR).
Several operational points stand out in this release. The document clarifies CTIS user role management, sponsor administration issues, OMS/XEVMPD registration expectations, CTIS publication rules, management of commercially confidential information (CCI) and personal data, and submission workflows for substantial modifications, additional member state applications, annual safety reports, and CSRs. It also provides updated clarification on how sponsors should approach public disclosure and redactions within CTIS.
A particularly relevant update is the clarification that XEVMPDweb is now browser-based and accessible across operating systems, reducing past limitations for organisations not using Windows-based environments. The FAQ also reinforces the importance of structured sponsor governance in CTIS, including role assignment, account continuity, and visibility controls across sponsor and CRO teams.
KEYWORDS: Clinical Trial, Submission Requirements, Sponsor Handbook
REFERENCE:https://www.ema.europa.eu/en/documents/presentation/clinical-trial-information-system-ctis-frequently-asked-questions_en.pdf