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Pharmacovigilance Inspection Program

Information on TGA's biennial Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey

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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 20 December 2024.

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’s Privacy policy to learn more about how the TGA will collect, hold and use the information you provide.

Instructions for completing the survey

You must complete and submit your survey responses online using the link below. This survey must be completed in one attempt only. Partially completed surveys will not be recorded and cannot be retrieved for later use. After completing the survey, a message will be displayed on your screen saying that your response has been recorded. You may also download a copy of your responses for your own records (please note that a copy of your responses will not be sent to your e-mail).

Please answer carefully and truthfully as we may ask for evidence of your responses during a pharmacovigilance inspection.

To help you prepare your responses, we have provided a copy of the survey questions in word and PDF. The copy of the survey questions is intended to help you answer the survey only and you must complete and submit your survey responses online using the link below.

Copy of survey questions

To make an enquiry or to seek assistance with the survey, please contact pharmacovigilance.inspections@health.gov.au.

Follow the link below to access the PVIP Risk Assessment Survey.

Begin PVIP Risk Assessment Survey

About the Pharmacovigilance Inspection Program

Following a successful pilot program conducted in 2015-16, the TGA's Pharmacovigilance Inspection Program (PVIP) was implemented as an initiative to help sponsors of medicines meet their pharmacovigilance obligations.

The TGA applies a risk management approach to ensuring that medicines included on the Australian Register of Therapeutic Goods (ARTG) meet acceptable standards of quality, safety and efficacy, and are subject to ongoing monitoring to ensure that these standards are maintained.

Pharmacovigilance is defined by the World Health Organization as the science and activity related to detecting, assessing, understanding and preventing adverse effects and other medicine-related problems.

The aim of therapeutic product vigilance is to continually monitor and evaluate the safety and efficacy (performance) profile of therapeutic products and to manage any risks associated with individual products.

The PVIP is a product vigilance program designed to facilitate the collection and evaluation of safety information relating to all medicines on the ARTG. It involves TGA representatives interviewing sponsors and reviewing documents in order to assess the sponsor's compliance with pharmacovigilance requirements set out in:

Sponsors have the primary responsibility for the safety of any therapeutic products they import, supply or export from Australia, and there are penalties for not meeting these obligations.

Inspections benefit sponsors by identifying areas within their existing pharmacovigilance practices where there may be gaps or where improvements could be made. This will help them to improve their pharmacovigilance systems and quality processes as a whole - ultimately ensuring the ongoing safety of medicines available to the Australian public.

Further information about Australia's therapeutic product vigilance system is available on the TGA website.

Inspection information for sponsors

Sponsors will be notified six to eight weeks prior to an inspection.

The announcement of the inspection will be in writing and may include, for example, the objectives, nature/type of the inspection, the dates and if known the address of the proposed inspection site(s).

In exceptional circumstances, an inspection may be performed without prior notice.

Inspection guidelines are based on the UK Medicines and Healthcare products Regulatory Agency (MHRA) guidelines, but also address relevant Australian issues and requirements.

Further information on the inspection process can be found in the PVIP Inspection guidelines.

Resources

Reports

The TGA publishes annual inspection program metrics reports containing de-identified information on the number of inspections held, the type of inspections, the type of findings and whether they have been resolved.

A summary of conclusions, in relations to comparisons over time, is included in these reports.

Presentations

Any TGA presentations relating to pharmacovigilance and the PVIP made in the past 12 months can be found on the TGA's presentations web page.

Contacts

For any PVIP-related enquiries, please email Pharmacovigilance.Inspections@health.gov.au.

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