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