The recent amendment to Regulation (EU) No 520/2012 — Implementing Regulation (EU) 2025/1466 — introduces significant changes in pharmacovigilance obligations for Marketing Authorisation Holders (MAHs).
One of the most impactful updates is that the review of EVDAS data for signal detection activities is now mandatory.
As stated in the new regulation:
“MAHs should describe how the data in EudraVigilance will be monitored and how those data will be used in conjunction with other available sources. During the signal management activities, MAHs shall monitor the data available in EudraVigilance in conjunction with those from other available data sources within their established processes with a frequency proportionate to the risk, the known safety profile of the product and the characteristics of the product.”
(EMA Q&A document)
This change represents a transition from the previous pilot obligation for selected substances to a broader, generalised application across all relevant products.
Implementation timeline:
- Most provisions will apply from 12 February 2026.
- Certain obligations related to EudraVigilance monitoring will already apply from 12 August 2025.
This amendment reinforces the central role of EVDAS monitoring and proactive signal management in ensuring patient safety and maintaining compliance with EU pharmacovigilance requirements.
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