In pharmacovigilance, patient safety always comes first. However, as regulators and industry professionals know, protecting personal data is equally vital. The upcoming GVP Module VI Addendum II – Masking of personal data in individual case safety reports (ICSRs), effective 25 July 2025, marks a significant shift in how companies handle sensitive information.

This article breaks down the essentials of masking of personal data in pharmacovigilance, explains the impact on ICSRs, and highlights what Marketing Authorisation Holders (MAHs) must do to stay compliant.

Why Is Masking of Personal Data in Pharmacovigilance Important?

The European Data Protection Supervisor (EDPS) recently audited EudraVigilance, focusing on pseudonymisation and data masking. The audit revealed inconsistencies in how personal data was protected across different organisations.

The EDPS recommended the creation of a standard masking policy, a unified approach to protecting personal information while ensuring that critical safety data remains available for signal detection.

What Does the New EMA Guidance Cover?

The new GVP Module VI Addendum II introduces a standardised masking policy for ICSRs. The objective is simple: strike the right balance between data privacy and pharmacovigilance utility.

Key points:

• Personal identifiers must be consistently masked.

• Some data fields must remain blank.

• Essential pharmacovigilance data must stay visible to ensure patient safety is not compromised.

Which Data Must Be Masked in ICSRs?

A total of 13 data elements are now subject to masking. These include:

Reporter’s details: title, given/middle/family name, organisation, department, street, post code, telephone.

Patient identifiers: medical record numbers (GP, specialist, hospital) and parent identification.

This ensures that sensitive identifiers cannot be traced back to individuals.

Data Fields That Must Stay Empty

The new guidance specifies 11 data elements that must remain blank, such as:

Sender’s details: title, given name, street, city, state, post code, country, telephone, fax.

This step reduces the risk of re-identification from sender-level information.

Information That Remains Visible for Safety Purposes

Pharmacovigilance teams do not mask all data. Some elements are critical for signal detection and risk assessment. These remain visible, including:

• Patient demographics: initials, date of birth, age, sex, height, weight.

• Drug details, MedDRA-coded events, and outcomes of reactions.

• Case identifiers and literature references.

The goal is clear: protect privacy without losing valuable insights for patient safety.

What the Changes Mean for Marketing Authorisation Holders

For MAHs, the new EMA requirements on masking of personal data in pharmacovigilance are more than just administrative updates. They represent a compliance priority directly impacting regulatory submissions and patient privacy protection.

To stay aligned with the guidance, MAHs must take several concrete steps:

• Adapt safety databases and data processing systems to apply the new masking logic to ICSRs automatically.

• Revise all EudraVigilance submissions to meet the standardised masking and redaction requirements.

• Introduce robust quality control measures to confirm that masked ICSRs remain compliant during preparation and after submission.

By embedding these measures into daily pharmacovigilance workflows, MAHs can safeguard sensitive information while supporting effective signal detection and patient safety monitoring.

Practical Steps for Compliance

With the new guidance now in effect, MAHs and pharmacovigilance teams should focus on:

• Update SOPs and workflows to reflect the new masking requirements.

• Train pharmacovigilance and data entry staff on handling personal data.

• Coordinate with IT/system vendors to build masking rules into safety databases.

• Conduct audits of current practices against the new GVP Module VI Addendum II.

Conclusion

The masking of personal data in pharmacovigilance is not just a regulatory obligation but a safeguard for patient trust. The industry can ensure privacy protection and robust pharmacovigilance by adopting a consistent approach.

The EMA guidance reminds us that patient safety and data protection are inseparable. Now is the time for MAHs to prepare, adapt, and ensure that every ICSR submitted to EudraVigilance meets the new standards.