A pharmacovigilance system is only as good as it looks under inspection. The EMA, the UK's MHRA, and the US FDA share the same underlying goal, timely, complete, and accurate safety reporting, but they inspect against different frameworks. Knowing where they align, and where they diverge, is the difference between a smooth inspection and a critical finding.
European Union, EMA and national authorities
EU inspections test compliance with Good Pharmacovigilance Practices (GVP). Inspectors expect a current Pharmacovigilance System Master File, a contactable QPPV, demonstrable signal management, and aggregate reports submitted on time. They will follow individual cases from receipt through to EudraVigilance, and check that your processes match what the PSMF describes.
United Kingdom, MHRA
Since Brexit the MHRA inspects against the Human Medicines Regulations 2012. Expect close attention to the UK QPPV, UK-specific reporting timelines through the MHRA Gateway, and how you manage divergence between Great Britain and Northern Ireland under the Windsor Framework. The system looks familiar to the EU one, but is assessed in its own right.
United States, FDA
FDA postmarketing inspections focus on written procedures, 15-day expedited reports, periodic reports, and contractor oversight. Inspectors verify clock-start dates, the completeness of FAERS submissions, and that Safety Data Exchange Agreements assign clear accountability.
What inspectors look for everywhere
Three things travel across all three regimes: procedures that match practice, evidence that timelines are met, and a culture of corrective and preventive action where issues are found, fixed, and prevented. Build the system so the documentation tells the same story your people do, and an inspection becomes a demonstration rather than a defence.