The European Medicines Agency (EMA) has announced new measures to strengthen the protection of personal data Individual Case Safety Reports (ICSRs) submitted to EudraVigilance. This follows recommendations from the European Data Protection Supervisor (EDPS), issued after an audit focused on pseudonymisation and data masking procedures. In response, the EDPS advised EMA, in collaboration with the European Commission and national competent authorities, to adopt a common masking policy to be followed by all entities submitting ICSRs to EudraVigilance.

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In response, an Addendum to GVP Module VI has been published to complement existing data protection guidance (Section VI.C.6.2.2.10). This Addendum outlines which ICH-E2B(R3) data elements are required to meet pharmacovigilance obligations under EU legislation and specifies how personal data should be masked.

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The changes apply to all senders of ICSRs to EudraVigilance, and the data fields to be masked or not to be provided should not go beyond the data fields described in this Addendum to GVP Module VI.

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With this update, the EMA is reinforcing its commitment to data protection while continuing to ensure the effectiveness of its drug safety monitoring system.

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