What Is a PSMF and Why Does Your Pharma Company in Egypt Need One?
The Pharmacovigilance System Master File is the document EDA inspectors reach for first. Most critical findings begin here.
If your company has products registered with Egypt's Drug Authority (EDA), you are required to have a functioning pharmacovigilance system. And the primary document that demonstrates your system is functioning — to EDA, to PVGA inspectors, and to yourself — is the Pharmacovigilance System Master File (PSMF). The PSMF is not a form you submit once and file away. It is a living document that describes your entire drug safety operation. When EDA conducts an inspection, the PSMF is the starting point. Most inspections that result in critical or major findings begin with a PSMF that is incomplete, outdated, or inconsistent with the actual system being operated.
What the PSMF must contain
Under EDA requirements — aligned with PVGA guidelines and ICH E2E — a compliant PSMF must document:
- The pharmacovigilance system overview — scope, structure, and relationship to the quality management system
- The Qualified Person for Pharmacovigilance (QPPV) — name, qualifications, contact details, and scope of responsibility
- Adverse event collection and reporting procedures — all source channels, ICSR generation, and submission within the 15-day expedited window
- Literature monitoring — databases searched, search frequency, and how relevant publications are processed
- Signal detection and management — how signals are identified, evaluated, and escalated
- Aggregate reporting — PSUR preparation process and EDA submission schedule
- Product list — all products covered by the system, with registration status per market
- Change log — documented history of significant system changes
What EDA inspectors look for
Based on EMCO Egypt's experience managing PSMFs through EDA inspection cycles, inspectors consistently focus on:
The gap between the PSMF and the actual system. The most damaging finding is when the PSMF describes a system that does not exist as documented.
QPPV qualification and availability. Inspectors verify the qualifications of the named QPPV. A junior team member without formal PV training creates a finding.
Adverse event intake completeness. Are all source channels — sales representatives, contracted healthcare professionals, the medical information function — trained and documented?
ICSR timeliness. For serious adverse events, the 15-day expedited reporting window is non-negotiable. Cases submitted even one day outside the window are findings.
Literature review evidence. Inspectors expect documented, systematic, scheduled searches with retrievable records.
The most common PSMF gaps
- The PSMF has not been updated since initial registration
- The product list is incomplete
- No evidence of adverse event training for the sales team
- Literature review is described but not actually being conducted
- The PSMF describes processes that are not being followed
Types of inspection findings
Critical
No functioning PV system. Serious adverse events not reported or reported well outside the 15-day window. QPPV not qualified. May result in product holds.
Major
PSMF incomplete or inconsistent. No literature monitoring evidence. Adverse event training not documented. ICSRs submitted late. PSURs not prepared.
Minor
SOP version control issues. PSMF not updated after portfolio changes. Training records incomplete. A cluster can escalate to major.
How EMCO Egypt manages PSMFs
EMCO Egypt builds and maintains PSMFs for every client on our pharmacovigilance outsourcing service. Our own PSMF has been formally audited. For companies managing their own PSMF in-house, PV Radar's documentation module provides structured PSMF maintenance. Learn more about EMCO Egypt or request a PV system assessment.
Common Questions About the PSMF
The PSMF must be updated whenever a significant change occurs — a new product added, a change in QPPV, or a revision to a core PV process. A formal annual review is required as a minimum.
A critical finding requires immediate CAPA submission and can result in product holds or suspension of registration status until remediation is complete and a follow-up inspection passed.
Yes. EMCO Egypt builds PSMFs from scratch and takes over and remediates existing PSMFs that do not meet EDA/PVGA requirements, as part of our PV outsourcing service.
Is your PSMF ready for the next EDA inspection?
A 30-minute conversation with EMCO Egypt will identify the gaps before the inspection arrives.
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