Defined term · Regulatory
Pharmacovigilance
The collection and analysis of reports of suspected adverse reactions after authorisation. Establishes that an event has been reported and, for an event named in a warning, is confounded by reporting…
§1Pharmacovigilance
§1.2Category
Regulatory — Terms describing the status of a compound before a competent authority.
§1.3Related terms
- Boxed warning — The most prominent warning a competent authority can require in product information. Signals regulatory concern; does not itself establish that the risk is realised in…
- Notoriety bias — Increased reporting of an adverse event following publicity about it, which inflates a pharmacovigilance signal without any change in incidence.
Compound Evidence Institute · CEI-GT-179 · https://compoundevidence.com/glossary/pharmacovigilance/ · retrieved 30 July 2026