Annual Report of the Pharmacovigilance Inspectors Working Group (PhV IWG) for 2019 and 2020

On 26 November 2021 the EMA published the annual report of PhV IWG for 2019 and 2020. It was adopted by the PhV IWG on 12 November 2021.

A total of 29 and 42 human pharmacovigilance inspections were respectively requested in 2019 and 2020 in the context of the program for pharmacovigilance inspection of companies with CAPs. Two inspections were requested by the CHMP in 2019 but were conducted in 2020. Three inspections were requested by the CHMP in 2020 but were conducted in 2021.

A total of 24 deficiencies, comprising 0 critical, 7 major (29,2%) and 17 minor (70,8%) were recorded for the CHMP requested inspections conducted in 2019 (period covered from 01/01/2019 until 31/12/2019).

A total of 103 deficiencies, comprising 12 critical (11,7%), 47 major (45,6%) and 44 minor (42,7%) were recorded for the CHMP requested inspections conducted in 2020 (period covered from 01/01/2020 until 31/12/2020).

The main findings observed in the 2019 and 2020 inspections are in accordance with the categorization of pharmacovigilance inspection findings agreed by the PhV IWG. The three most common areas with findings in the 2019 inspections were:

  • adverse event expedited reporting, ICSRs;
  • pharmacovigilance system master file;
  • QPPV function.

The three most common areas with findings in the 2020 inspections were:

  • adverse event expedited reporting, ICSRs;
  • computerized system used for pharmacovigilance activities;
  • quality management system.
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