Insights

On 2 September 2026, the European Medicines Agency (EMA) published new sponsor guidance for the Annual Safety Report (ASR) Safety Module in CTIS. The module is currently available in the Sponsor CTIS training environment and is expected to go live in the CTIS Sponsor Workspace on 28 September 2026.

From the go-live date, all new ASRs must be submitted through the new Safety Module. A two-month transition period is foreseen until 28 November 2026, during which assessments already initiated through the old functionality may continue there.

The module introduces dedicated Sponsor Safety Admin and ASR Submitter roles and supports two submission approaches: Clinical Trial-centric ASRs, covering a single trial, and Substance Group-centric ASRs, covering eligible trials associated with a Substance Group.

The guidance also details ASR preparation, validation and submission, as well as the management of Requests for Information (RFIs). When an RFI is issued, the default sponsor response deadline is 14 days, although the assessing Member State may shorten it.

Sponsors are encouraged to familiarize themselves with the new workflow and review EMA’s listed known issues and workarounds ahead of implementation.

RPN will provide any further updates and is available to provide full support for CTIS and clinical trial activities.