Pharmacovigilance Inspection Program Risk Assessment Survey

The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open for medicine sponsors to complete. The survey will remain open until 18 December 2022.

Background

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

Please note that the survey questions relate only to your medicines (not medical devices or biologicals) included in the ARTG. This includes all listed, registered and provisionally registered medicines.

Please read the Department of Health and Aged Care's Privacy Policy to learn more about how the TGA will collect, hold and use the information you provide.