PSMF Oversight
The Pharmacovigilance System Master File (PSMF) is a core component of the European pharmacovigilance framework and an important area of oversight for QPPVs.
What is a PSMF?
The Pharmacovigilance System Master File (PSMF) is a detailed description of the pharmacovigilance system used by a marketing authorisation holder.
It provides regulators with a structured overview of the people, processes, systems and controls used to meet pharmacovigilance obligations.
Relationship Between the QPPV and the PSMF
The QPPV is expected to maintain awareness of the content, location and operation of the PSMF.
Although responsibility for maintaining individual sections may be delegated, the QPPV should understand how the document reflects the current pharmacovigilance system.
Why Regulators Review the PSMF
The PSMF provides inspectors with a high-level view of the pharmacovigilance system.
Discrepancies between the documented system and actual practice may be identified during inspections and may result in observations or findings.
Common Areas of Oversight
- Organisational structure and responsibilities
- QPPV and deputy arrangements
- Vendor and partner oversight
- Computerised systems used for pharmacovigilance
- Quality system documentation
- Compliance monitoring activities
- Business continuity arrangements
Inspection Readiness
Maintaining an accurate and current PSMF is an important aspect of inspection readiness.
Many organisations establish periodic review processes to ensure that changes in the pharmacovigilance system are reflected in the PSMF.
Practical Perspective
In practice, effective PSMF oversight requires collaboration between pharmacovigilance, quality, regulatory affairs, information technology and vendor management functions.
The QPPV should be able to explain how the documented system operates in reality and how important pharmacovigilance activities are governed.
Related Guides
Last reviewed: June 2026