Australian TGA Pharmacovigilance Inspection Program Metrics Report: January – December 2019

On 4 May 2020 the Health Department of the Australian Government TGA published the metrics report of pharmacovigilance inspections during 2019.

From 1 January 2019 to 31 December 2019, the Therapeutic Goods Administration (TGA) conducted 10 pharmacovigilance inspections of Australian medicine sponsors, in accordance with the Pharmacovigilance Inspection Program.

10 routine pharmacovigilance inspections were completed in 2019. There were no ‘for-cause’ inspections or re-inspections.

Inspections identified:

  • 1 critical deficiency
  • 41 major deficiencies
  • 36 minor deficiencies

This metrics report provides a high-level overview of inspection deficiencies, including a comparison of deficiencies identified in the first reporting period, to assist sponsors with improving their pharmacovigilance systems and preparing for pharmacovigilance inspections.

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