Pharmacovigilance

Pharmacovigilance (PV / GVP)

Pharmacovigilance exists because a marketing authorisation is granted on incomplete evidence. Pre-approval trials involve a few thousand carefully selected participants over a limited period; they cannot detect rare adverse reactions, effects in populations excluded from the trials, interactions with medicines the participants were not taking, or harms that emerge only after years of exposure. Post-market surveillance is how those are found.

The operational cycle runs from collection to action: individual case safety reports arrive from spontaneous reporting, literature, studies, and patients; they are assessed and coded; aggregate reports (PSURs/PBRERs) periodically re-examine the benefit-risk balance; signals are detected, validated, and assessed; and where a signal is confirmed, action follows — a label change, a risk-minimisation measure, restricted use, or in the extreme, withdrawal.

The obligations are legal and time-bound, and they persist for the entire life of the product. In the EU the system must be described in the PSMF and owned by a QPPV, and the whole apparatus is inspectable. Under-reporting is the field’s structural weakness: spontaneous systems capture a fraction of actual reactions, which is why signal detection increasingly draws on databases, registries, and real-world evidence rather than spontaneous reports alone.

• —Exists because approval rests on limited evidence — rare, delayed, and population-specific harms surface later.
• —Cycle: case collection → assessment → aggregate reporting → signal detection → action.
• —Actions range from label changes and risk-minimisation measures to restricted use or withdrawal.
• —Obligations are legal, time-bound, and last the product’s whole lifecycle.
• —In the EU the system is described in the PSMF and owned by a QPPV; it is inspectable.
• —Spontaneous reporting captures only a fraction of reactions — hence registries and real-world data.

EU: Directive 2001/83/EC and Regulation (EC) No 726/2004 as amended, Commission Implementing Regulation (EU) No 520/2012, and the EMA GVP Modules; US: 21 CFR 314.80 and 600.80, FDAAA 2007; ICH E2A-E2F for definitions, expedited reporting, and periodic benefit-risk evaluation.