Adverse Event Reporting
The process of documenting and submitting reports of adverse drug reactions to regulatory authorities. Healthcare professionals and patients can submit reports. Mandatory reporting is required for serious adverse events. These reports form the basis of post-marketing safety surveillance for all approved drugs.
Technical Context
Reporting obligations vary by reporter: manufacturers/marketing authorisation holders must report ALL serious adverse events to regulatory authorities within 15 calendar days (7 days for fatal/life-threatening unexpected events), and submit periodic safety update reports (PSURs/PBRERs) at defined intervals. Healthcare professionals are encouraged (and in some jurisdictions legally required) to report suspected ADRs. Patient reporting is increasingly facilitated through online portals. In the US, MedWatch Form 3500 (voluntary, for HCPs and consumers) and 3500A (mandatory, for manufacturers) are the standard reporting mechanisms. The FDA Adverse Event Reporting System (FAERS) database contains over 20 million reports and is publicly searchable via the OpenFDA API. Under-reporting is a well-recognised limitation — estimated reporting rates are 1-10% for most ADR types, with higher rates for serious events.