Australia rolls out Pharmacovigilance Inspection Program

1 September 2017

Australia’s Therapeutic Goods Administration (TGA) has announced the implementation of the Pharmacovigilance Inspection Program (PVIP).

Aimed at helping drugmakers to meet their pharmacovigilance obligations and to ensure the safety of medicines for patients, PVIP is being rolled out following a successful pilot conducted in 2015-16.

It is designed to facilitate the collection and evaluation of safety information relating to all medicines on the Australian Register of Therapeutic Goods (ARTG) and comprises of TGA representatives interviewing sponsors and reviewing documents in order to assess the sponsor's compliance with pharmacovigilance requirements.

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