EMA Updates the Sponsor Handbook for CTIS: Key Highlights for Pharmacovigilance Stakeholders

In July 2025, the European Medicines Agency (EMA) released an updated version of the Sponsor Handbook for the Clinical Trials Information System (CTIS), further streamlining processes introduced under the EU Clinical Trial Regulation (CTR) No. 536/2014. The updated handbook is a practical tool designed to support sponsors, both commercial and non-commercial, in effectively navigating the CTIS environment. Among the enhancements, there are updates also involving pharmacovigilance (PV) professionals of a clinical trial.

The revised handbook emphasizes the importance of early planning and integration of pharmacovigilance processes in the CTIS workflow. Sponsors are reminded that safety reporting must remain compliant with EU guidance and be aligned with the Development Safety Update Report (DSUR) obligations, submitted annually via CTIS. The updated guidance provides clearer instruction on how to manage safety-related communications within CTIS, including the proper classification of substantial modifications related to investigational product safety.

One of the key pharmacovigilance updates includes a more detailed explanation of roles within the CTIS user management model, with specific reference to PV oversight responsibilities. Sponsors are advised to clearly assign and document roles related to safety data management, particularly regarding the communication of urgent safety measures (USMs), serious breaches, and temporary halts or early trial terminations due to safety concerns.

The handbook provides updated timelines and practical steps for submitting safety-related notifications. This includes enhanced clarity on:

• When and how to notify suspected unexpected serious adverse reactions (SUSARs) within clinical trials.

• Submission requirements for serious breaches involving participant safety.

• The correct use of the CTIS interface for reporting urgent safety measures, particularly in multinational trials where coordination across multiple Member States is essential.

The revised document helps reduce discrepancies in interpretation among Member States and facilitates a more consistent and transparent approach to clinical safety management.

The updated EMA Sponsor Handbook for CTIS is a crucial reference for ensuring compliant and efficient regulatory, clinical and pharmacovigilance operations throughout the clinical trial lifecycle. ClinOpsHub strongly encourages PV professionals to review the latest version to ensure alignment with evolving regulatory expectations and to optimize their contributions to trial safety and oversight.

Check out our free course presenting ClinOpsHub CRO services https://www.formazionenelfarmaceutico.com/p/clinopshub-pharmacovigilance and get in touch with us at pv@clinopshub.com.