Sarcouncil Journal of Internal Medicine and Public Health

Abstract: Inspection readiness is a core organisational capability for marketing authorisation holders and equivalent FDA-regulated application holders in the US, EU/EEA, and UK markets. It is not only about readiness for the next inspection, but also about routine management of safety information, governance, signal detection, risk minimisation, vendor management and traceability of evidence to support pharmacovigilance decisions. This review examines peer-reviewed literature since 2015 that contributes to inspection readiness, including regulatory intelligence, quality of safety databases, patient safety reporting, social media, real-world data, artificial intelligence and risk minimisation. The review shows a gap between the abundant research on pharmacovigilance methods and the paucity of evidence from inspection experience, categories of inspection observations, and maturity of readiness. FDA, EMA and MHRA expectations of timeliness of case processing, valid safety assessment, documented quality systems and corrective action can be harmonised for inspections, but the research literature focuses more on technical surveillance methods than on pharmacovigilance quality systems and inspection evidence. Further research is needed for comparable measures of inspection readiness, maturity models and empirical research on the impact of digital systems on inspection readiness.