Pharmacovigilance Lawbreakers Could Lose Drug License Under Australia’s New Inspection Program

 
• By Neena Brizmohun

Pharmacovigilance inspections are to commence soon under a new program the Therapeutic Goods Administration has implemented to strengthen and broaden its post-market monitoring activities. Inspections will be mainly limited to Australian affiliate sites, though overseas sites might be inspected too.

Magnifying glass focusing on Australia
Australian pharmacovigilance inspections to start soon

Post-marketing safety inspections are to start soon in Australia under a newly implemented pharmacovigilance inspection program (PVIP) that will also allow the Therapeutic Goods Administration to cancel or suspend drug registrations, or prosecute companies in cases of significant non-compliance.

Pharmacovigilance inspections will apply to sponsors that have medicines listed and registered on the Australian Register of Therapeutic Goods

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