New Pharmacovigilance (PV) Inspection Guide by Australian Health Authority

The Therapeutics Goods Administration (TGA) issued a new guidance for medicine sponsors on PV

The Therapeutic Goods Administration (TGA) conducts a range of pharmacovigilance activities to monitor the safety and efficacy of medicines in Australia and, where necessary, take appropriate action.

The pharmacovigilance responsibilities of sponsors of medicines included on the Australian Register of Therapeutic Goods (ARTG) and regulated by the TGA are set out in the Pharmacovigilance responsibilities of medicine sponsors—Australian recommendations and requirements.

The TGA inspects Australian sponsors to assess whether they are meeting their pharmacovigilance responsibilities.

This guidance will help sponsors understand TGA’s pharmacovigilance inspection program (PVIP). It outlines how TGA prepares, conducts, reports and follows up pharmacovigilance inspections and lists the criteria TGA uses when scheduling inspections.

Read the pdf
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