How Often Should a PSMF be Reviewed?

The Pharmacovigilance System Master File (PSMF) should be maintained as a living document that accurately reflects the current pharmacovigilance system at all times.

There is No Universal Review Frequency

Regulations generally focus on ensuring that the PSMF remains accurate and current rather than prescribing a specific review interval.

Organisations should establish review processes that ensure significant changes are reflected promptly.

Events That Should Trigger a Review

Appointment of a new QPPV
Changes to deputy arrangements
New vendor relationships
Safety database changes
Organisational restructuring
Governance changes
Inspection findings

Periodic Reviews

Many organisations perform formal quarterly, semi-annual or annual reviews of the PSMF to confirm continued accuracy.

These reviews often complement change-driven updates.

Inspection Perspective

Inspectors frequently compare the PSMF against actual practice. Discrepancies may indicate weaknesses in oversight, governance or document maintenance.

Practical Perspective

The best review frequency is one that ensures the PSMF always reflects reality. Effective organisations treat the PSMF as a continuously maintained management document rather than a periodic compliance exercise.

Last reviewed: June 2026