Insights

On 22 July 2025, the European Commission published the Regulation (EU) 2025/1466, introducing important amendments to Regulation (EU) No 520/2012, set to apply from 12 February 2026.

Here below the key aspects changed:

🔹 Pharmacovigilance System Master File (PSMF)

Only major or critical deviations from pharmacovigilance procedures will now need to be documented in the PSMF, until their resolution.

🔹 Subcontractor Oversight

The regulation introduces explicit requirements for third-party service providers. Contracts must clearly define roles, responsibilities, data exchange modalities, and audit rights.

🔹 Audit & Quality Systems

MAHs are required to perform risk-based internal audits across their entire pharmacovigilance system, including third parties. These audits must be independent, scheduled regularly, and form part of a strategic compliance plan.

🔹 Eudravigilance Monitoring

MAHs shall continue to monitor the data available in the Eudravigilance database and use them as an additional source of safety information to support their processes and enhance signals detected through other sources. However, they are no longer requested to detect and submit via the standalone signal notification form signals when monitoring the Eudravigilance database. Signals detected through all sources, including the EudraVigilance database, should be handled according to the marketing authorisation holder’s own signal management process. MAHs should describe in their procedure how the data in EudraVigilance will be monitored and how those data will be used in conjunction with other available sources.

🔹 Literature Reporting

References in ICSRs must now include a Digital Object Identifier (DOI), where applicable.

🔹 PSUR & PASS Requirements Updates

PSURs shall descrive both implementation and effectiveness evaluation of all the risk minimisation measures.
As regard the PASS, MAHs shall submit electronically the study protocol before the start of the data collection and the abstract of the final study report within one month after the finalisation of the final study report.

🔹 Global Standards Terms – IDMP and MedDRA

The regulation mandates the use of ISO IDMP standards and MedDRA terms across all pharmacovigilance processes, including safety submissions, product identification, and terminology management. This step fosters interoperability, improves data quality, and aligns EU practice with ICH and international standards.

This updated regulation represents a step forward in strengthening pharmacovigilance oversight and aligning EU practices with evolving global standards.

An update to the Good Pharmacovigilance Practices (GVP) IX is scheduled to be implemented in Q2 2026, in alignment with the forthcoming requirements.

RPN will provide any further update and is available to provide full support for pharmacovigilance and regulatory compliance activities.