MHRA Pharmacovigilance Inspection Metrics: April 2019 to March 2020

On 26 February 2021 the MHRA GPvP inspectorate published the latest inspection metrics for the period from April 2019 to March 2020.

During the period 01 April 2019 to 31 March 2020, the MHRA’s Good Pharmacovigilance Practice (GPvP) inspectorate conducted 22 inspections of marketing authorization holders (MAHs). The purpose of these inspections was to examine compliance with existing EU and national pharmacovigilance regulations and guidelines.

A total of five critical, 76 major and 46 minor findings were identified during this reporting period. All five critical findings were in the area of risk management, specifically:

  • three in relation to maintenance of reference safety information
  • one in relation to implementation of additional risk minimization measures
  • one in relation to management of additional pharmacovigilance activities in Part III of the risk management plan (RMP)

The highest proportion of major findings were reported in relation to risk management, with 23 findings (30%). This was followed by activities relating to the quality management system with 20 findings (26%), ongoing safety evaluation with 14 findings (18%) and management of adverse drug reactions with 13 findings (17%).

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