Pharmacovigilance Inspection Report

The MHRA GVP inspectorate recently published the pharmacovigilance inspection report for the period from April 2020 to March 2021. Pharmacovigilance inspection metrics have been published since 2009 and are based on PV inspections carried out annually.

The reports include information on:

• The number and type of marketing authorization holders (or M.A.H.s) inspected
• The areas associated with common inspection findings
• The number of critical, major, and minor findings

Following Brexit, the UK entered a transition period where European Union law continued to apply and therefore inspections continued to be conducted following EU regulations (until 31 December 2020).

Since the end of the transition period, inspections have been conducted following the Human Medicines Regulations 2012 (or H.M.R.) and GVP Module III, as modified by the “Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the licensing authority”.