Pharmacovigilance System Master File(PSMF)
The document describing the pharmacovigilance system operated by a Marketing Authorization Holder for EU-approved medicinal products.
Usage Examples
- The PSMF documented the integrated EU pharmacovigilance system including outsourced signal detection services.
- An EMA pharmacovigilance inspection used the PSMF as the starting point for system assessment.
What is PSMF?
The PSMF is a central document describing the Marketing Authorization Holder's pharmacovigilance system structure, processes, and resources. Required under EU Directive 2001/83/EC as amended, the PSMF replaced the older Detailed Description of Pharmacovigilance System (DDPS) in 2012 and must be available for inspection at the EU QPPV's location.
PSMF content includes: QPPV identification and qualifications, MAH organizational structure supporting pharmacovigilance, source systems (adverse event databases, literature monitoring, signal management), pharmacovigilance procedures, quality system documentation, compliance data (ICSR submission rates, PSUR timeliness), and contracts with third parties performing pharmacovigilance activities. PSMF is kept current as a living document; major changes are notified to EMA. EU GMP-equivalent pharmacovigilance inspections rely heavily on PSMF review.
Regulatory Context
This term appears most often in pharmacovigilance workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside DIRECTIVE 2001 83 EC, REGULATION EC 726 2004, GVP MODULE II.
When This Matters
- The PSMF documented the integrated EU pharmacovigilance system including outsourced signal detection services.
- An EMA pharmacovigilance inspection used the PSMF as the starting point for system assessment.
Common Mistakes
- Treating safety signal reviews as periodic instead of continuous.
- Not linking new enforcement letters to internal CAPA and labeling workflows.
- Using static templates for dynamic benefit-risk communication updates.
Related Regulations
Frequently Asked Questions
PSMF is specifically required for products with EU marketing authorization. Non-EU products don't require a formal PSMF but MAHs benefit from equivalent internal documentation. Global companies typically maintain one integrated PSMF covering EU products plus their broader system.
Continuously as a living document. Annual reviews are standard practice; major system changes trigger immediate updates. Changes affecting QPPV identity, major structural reorganization, or new outsourcing relationships require EMA notification via Article 57 database update.
At the EU/EEA site where the QPPV performs their principal activities. The location is registered in the Article 57 database. It must be available for immediate inspection during EMA or national competent authority pharmacovigilance audits.
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Sources & References
