Pharmacovigilance Inspection Program Risk Assessment Survey

On 30 June 2020 the Australian TGA announced that the PVIP Risk Assessment Survey is open for medicine sponsors to complete.

The Australian Therapeutic Goods Administration's (TGA) PVIP Risk Assessment Survey is designed to inform the TGA about a sponsor's medicine portfolio, pharmacovigilance processes, inspection history and compliance with Australian pharmacovigilance legislation and guidelines, and will serve as a tool to help prioritize and schedule pharmacovigilance inspections (please refer to the full guidance on pharmacovigilance inspections to learn more about the TGA's approach to prioritizing inspections).

Any sponsor who has at least one medicine included in the Australian Register of Therapeutic Goods (ARTG) should complete this survey. Medicine sponsors that do not complete this survey will be assigned the highest survey risk score.

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