PSMF (Pharmacovigilance System Master File)
What is it?
The PSMF is a detailed description of an MAH's entire pharmacovigilance system: who the QPPV is, how the PV organization is structured, where the safety database lives, and how the whole quality system is kept compliant. It's kept at a single, real location, referenced by every marketing authorization dossier the company holds, rather than duplicated per product.
Because it's the one document meant to describe everything else, it's also the first thing a regulator asks for during an inspection. It has to be accurate and current at all times, not assembled after the fact when someone asks to see it.
Open the file
Click the button below to see what a PSMF actually has to contain.
QPPV & Contacts
Who holds the role, and exactly how to reach them.
Org Structure
How the PV function is organized, staffed, and overseen.
Safety Database
Where and how every case for every product gets stored.
Quality System
The procedures that keep the whole PV system compliant.
Audit History
What past inspections found, and what changed as a result.
Common Misconceptions
"The PSMF sounds like internal admin paperwork, low priority compared to actual case processing."
It's usually the very first document a regulator requests during an inspection, since it's meant to describe whether the entire PV system actually functions the way it's supposed to. It has to stay audit-ready at all times, not get assembled after the fact.
