Pharmacovigilance Inspection Metrics

The MHRA GVP inspectorate recently published their latest pharmacovigilance (PV) inspection metrics for the period from April 2019 to March 2020. The inspection metrics have been published since 2009 and are based on PV inspections carried out annually. They include information on

  • the number and type of marketing authorization holders (MAHs) inspected,
  • the areas associated with common inspection findings,
  • the number of critical, major and minor findings.

Following the Brexit, the UK entered a transition period where Union law continued to apply and therefore inspections continued to be conducted in accordance with EU regulations. The MHRA previously provided guidance on pharmacovigilance requirements for UK authorised products from 1 January 2021.

Types of Inspections and Summary of Findings

In total, 22 inspections were conducted during this metrics period. Five inspections were triggered to assess the resolution of critical findings from previous inspections, one was triggered due to information received and 16 inspections were conducted in line with routine national inspection schedules. 15 onsite inspections included an element of remote (office-based) inspection. One inspection was conducted entirely remotely to develop an approach for remote GVP inspections, which is highly needed during the current COVID-19 pandemic.

The highest number of all findings in the reporting period related to risk management followed by quality management systems (QMS). In detail, the following findings have been observed:

  • Critical findings 
    5 critical findings were identified from five inspections. All five critical findings were in the area of risk management, in particular:
    - 3 in relation to maintenance of reference safety information (e.g. patient information leaflets (PILs) with updated safety information had not been packaged and released to market within the required timeframes)
    - 1 in relation to implementation of additional risk minimisation measures (e.g. failure to implement educational material to inform patients and healthcare professionals of important risks and potential overdose due to medication errors)
    - 1 in relation to management of additional pharmacovigilance activities (e.g. delays in reporting serious adverse events to the MAH, inaccurate or incomplete data entry into the electronic data capture system)

  • Major findings
    In total, 76 major findings were identified. The highest proportion of major findings were reported in relation to
    - risk management, followed by
    - QMS (e.g. audit and deviation management, corrective and preventive action (CAPA) management; pharmacovigilance system master File (PSMF) management),
    - ongoing safety evaluation and management of adverse drug reactions.
    In comparison to the previous reporting period (2018/19), the proportion of risk management major findings increased from 21% to 30%, QMS findings increased from 15% to 26%.

  • Minor findings
    46 minor findings were identified in this reporting period. The largest proportion of minor findings was (again) in relation to QMS and risk management, followed by findings regarding ongoing safety evaluation, management of adverse drug reactions and collection and collation of adverse drug reactions. In comparison with the previous reporting period, collection and collation of adverse drug reactions had a much lower proportion of minor findings in this reporting period.

For more detailed information please see the Pharmacovigilance inspection metrics April 2019 to March 2020 in the MHRA Inspectorate Blog.

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