The Guidelines on Good Pharmacovigilance Practices (GVP) I.B.1. provide a definition of the Pharmacovigilance (PV) system:
‘A PV system is defined as a system used by an organisation to fulfil its legal tasks and responsibilities in relation to PV and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. A PV system, like any system, is characterised by its structures, processes and outcomes.’
While processes are described in the following chapters and modules, descriptions about structures or results are much more difficult to find.
When a system indicates ‘a set of interacting or interdependent component parts forming a complex/intricate whole’ (Wikipedia), then it appears meaningful to define these component parts. Here’s a suggestion for PV:
- Qualified personnel (incl. Qualified Person responsible for Pharmacovigilance (QPPV) / Graduated Plan Officer),
- Clear overall objectives,
- Meaningful and sustainable structures,
- Appropriate resources (e.g. incl. data base),
- Descriptions of tasks and processes,
- Measuring and ensuring expected results, incl. measures if not achieved,
- Comprehensible documentation.
It is the purpose of the PV System Master Files (PSMF) to describe the PV system – and to monitor it. It has been mandatory for all marketing authorisation holders in the EU since 21 July 2015.
Three clues concerning PSMFs gained by experience:
- Do not describe all details, but describe comprehensibly,
- Characterise all mandatory (GVP I.B.11.3.; II.B.4.5.; Implementing Regulation 520/2012, Article 11(1)) and meaningful processes (e.g. PSMF management, website screening),
- Continuous maintenance of the PSMF: Easy, but controlled.