The new CTIS Safety Module for Annual Safety Reports (ASRs) is now available in the CTIS training environment and will go live in the CTIS Sponsor Workspace on 28 September 2026.
The new functionality introduces a dedicated Safety Module and a centralised Annual Safety Reporting workspace, enabling sponsors to draft, submit, track and download ASRs, with visibility of reports in Draft, Submitted and Finalised status. The module supports both substance group-centric and clinical trial-centric ASR submissions.
The new module also streamlines Requests for Information (RFIs) through dedicated workflows and Notice Centre notifications, allowing sponsors to manage regulatory interactions directly within the Safety Module.
Two-month transition period
Importantly, a two-month transition period will follow the go-live. During this period, all new ASRs must be submitted through the new Safety Module, while ongoing assessments initiated under the legacy ASR functionality can still be completed through the existing process.
Any ASRs with assessments that remain incomplete at the end of the transition period will no longer be accessible via CTIS. The assessment will instead continue outside CTIS under the responsibility of the already assigned Safety Assessing Member State (saMS).
The new Safety Module represents a positive step towards more harmonised, transparent and efficient safety oversight under the Clinical Trials Regulation. For sponsors, CROs and drug safety professionals, now is the time to familiarise themselves with the new processes, user roles and transition arrangements.
Need support with the new CTIS Safety Module?
If you need support managing CTIS and clinical trial safety activities, Medfiles’ clinical trial and pharmacovigilance experts are happy to help. Our teams have experience in CTIS-related activities and clinical trial safety reporting, and support can be tailored to your specific needs.
Author:
Satu Kujala, Head of Pharmacovigilance
Satu Kujala has worked at Medfiles since 1999 acting in various leadership positions. She is currently serving as Head of the Pharmacovigilance team consisting of 20 experts in Finland and Baltics.
Satu has a Licentiate’s degree in Philosophy (pharmacy), and she has specialised in pharmacology and industrial pharmacy. She graduated from the University of Helsinki. After a short career in the university and pharmacy, she has worked within the pharmaceutical industry for 30 years and has gained diverse experience through working on marketing, quality, wholesale, clinical trials, safety and regulatory tasks. She is familiar with Good Clinical, Pharmacovigilance and Distribution Practices (GCP, GVP and GDP). Acting as EU QPPV for sixteen years has given her deep knowledge and experience of pharmacovigilance systems.
See also:
