On 22 July 2025, the Commission Implementing Regulation (EU) 2025/1466 was issued, coming into effect on 12 August 2025. This new regulation introduces significant updates to the European pharmacovigilance framework, particularly in relation to signal management processes.
One of the main changes is the mandatory use of the EudraVigilance Data Analysis System (EVDAS) as a source for signal detection, in addition to its already established role in signal validation and assessment.
Under now, many Marketing Authorisation Holders (MAHs) used EVDAS data once a safety signal had already been identified. Under the new regulatory requirements, EVDAS must be incorporated across all stages of signal management process, meaning that MAHs will need to routinely review EVDAS outputs as part of signal detection activities.
This change aligns with the European Medicines Agency’s ongoing efforts to strengthen proactive pharmacovigilance and ensure a harmonised approach to signal detection within the European Economic Area (EEA).
Operational Impact for Pharmaceutical Companies after Commission Implementing Regulation (EU) 2025/1466
The implementation of this regulation requires all MAHs to:
- Use EVDAS data as a mandatory source for signal detection, alongside other established data sources.
- Conduct cumulative analyses for initial implementation, followed by scheduled periodic reviews.
- Perform EVDAS screening for all authorized medicinal products in the EEA, irrespective of their current marketing status.
- Ensure that post-detection activities (monitoring, validation, and assessment) focus on signals related to suspected adverse reactions, in accordance with the updated regulation.
As a result, companies may need to review and updated internal signal detection procedures, work instructions, and the Pharmacovigilance System Master File (PSMF) to maintain regulatory compliance.
How PVpharm can support MAHs
At PVpharm, we support MAHs in adapting to these changes by:
- Updating signal detection procedures to incorporate the mandatory use of EVDAS according to Regulation (EU) 2025/1466.
- Accessing, analysing and interpreting EVDAS data, including both cumulative and periodic outputs.
- Providing methodological guidance for signal identification and prioritisation, including customised threshold settings based on each product’s profile.
- Offering training and operational support for pharmacovigilance and signal management teams to ensure a smooth and efficient implementation.
If your organisation is reviewing how to adapt its signal management activities to the new regulatory framework, or you need practical guidance on integrating EVDAS into your procedures, PVpharm can help.
We can support you throughout the whole implementation process or in specific stages, depending on your needs.
Contact us for further information.
