CTIS updates strengthen compliance and transparency
The Clinical Trials Information System (CTIS) has introduced several updates aimed at improving safety reporting, communication, and regulatory compliance for sponsors.
New safety module for Annual Safety Reports (ASRs)
As of 28 September 2026, all new Annual Safety Reports must be submitted through CTIS's new Safety Module. The module enables sponsors to create, submit, and track ASRs within a single environment, including the management of Requests for Information (RFIs), notifications, and status updates.
Email notifications now available
CTIS users can now opt in to receive email alerts whenever new notifications or warnings are generated in the system. This feature helps sponsors stay informed and respond more efficiently to regulatory activities. Instructions for enabling notifications are available in Section 3.2 of the CTIS Sponsor Handbook.
Reminder to keep CTIS information current
The Swedish Medical Products Agency (MPA) reminds sponsors to ensure that trial information in CTIS remains accurate and up to date. This includes reporting trial start and end dates, temporary halts, and early terminations in accordance with the Clinical Trials Regulation (CTR).
Reporting trial results remains a key obligation
Sponsors are also reminded of their responsibility to submit clinical trial results, including lay summaries, through CTIS. Results must be submitted within one year of trial completion for adult studies and within six months for pediatric studies.
Together, these updates reflect the continued evolution of CTIS as the central platform for clinical trial submissions, safety reporting, and regulatory oversight in the EU.
Need support with CTIS? Aurevia's experts help sponsors manage CTIS submissions, safety reporting, and regulatory compliance throughout the clinical trial lifecycle. Contact us to learn more about our clinical operations.
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