Date of Publication (Latest update): 05-Feb-2026
INTELLIGENCE OVERVIEW
The European Medicines Agency (EMA) has published an updated data protection notice for EudraVigilance (Human), clarifying how personal data are processed within the EU pharmacovigilance system
Industry Impact
This update has important implications for MAHs, pharmacovigilance service providers, and CROs:
- Reinforces GDPR compliance obligations in adverse event reporting
- Increases transparency on data access, retention, and sharing within EudraVigilance
- Requires companies to review internal PV procedures and privacy notices
- Reduces regulatory risk linked to data protection non-compliance
Overall, the notice strengthens trust in the EU pharmacovigilance system while raising expectations for data governance and accountability across the pharmaceutical industry.