Annual Report of the Pharmacovigilance Inspectors Working Group for 2018

On 2 July 2020 the EMA announced the availability of the 2018 PV annual report.

A total of 255 pharmacovigilance inspections were conducted for human medicinal products in 2018 in EU/EEA. Of these, 47 human pharmacovigilance inspections were requested in 2018 in the context of supervisory authority inspections of marketing authorisation holders (MAHs) with centrally authorised products (CAPs).

A total of 175 findings, 18 critical (10,3%) and 157 major (89,7%), were identified during the supervisory authority inspections conducted in 2018 (period covering 01/01/2018 to 31/12/2018). These numbers include both supervisory authority inspections of MAHs with CAPs requested by the Committee for Medicinal Products for Human Use (CHMP) and supervisory authority inspections that were conducted under national inspection programmes.

The three most common areas with findings were:

  • Management and reporting of ICSRs;
  • Quality assurance;
  • Signal management.

There were no critical or major findings related to local qualified persons responsible for pharmacovigilance (QPPV).

Read the pdf 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /