Good Pharmacovigilance Practice

Good Pharmacovigilance Practice governs how the safety of medicines is monitored once they are on the market (EU GVP Modules and equivalents) — collecting, assessing, and acting on adverse-event and signal data to protect public health across the entire product lifecycle. It is the discipline that keeps a licensed product’s benefit–risk balance under continuous review.

Pre-approval trials cannot surface every rare or long-latency risk; post-market surveillance is where those signals actually emerge. Late detection or a reporting failure can cost lives and a marketing authorization, and pharmacovigilance findings routinely trigger regulatory action. GVP is the safety net for the whole marketed portfolio.

Capturing individual case safety reports from every source and reporting them to authorities within defined timelines — the raw material of safety surveillance.

Detecting, validating, assessing, and acting on safety signals — turning a scatter of case reports into a substantiated change in what is known about a medicine.

A Pharmacovigilance System Master File that describes the system, and a Qualified Person for Pharmacovigilance accountable for its operation and oversight.

Documented risk-minimisation and pharmacovigilance activities proportionate to a product’s risks, kept current as the safety profile evolves.

• ›Case processing quality and reporting timeliness (expedited and periodic)
• ›Signal detection, evaluation, and the actions taken from it
• ›Currency and accuracy of the Pharmacovigilance System Master File
• ›The QPPV’s oversight and access to the full safety system

Derived from the 5 standards SPEQ decodes for this discipline.