Biovigilance responsibilities of sponsors of biologicals

Australian requirements and recommendations

13 December 2017

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Introduction

This guidance is for all sponsors of products regulated as biologicals and does not apply to sponsors of biological medicines or other therapeutic goods that are not regulated as biologicals. It outlines the mandatory reporting and record-keeping requirements and offers recommendations on biovigilance best practice.

In this guidance, we use 'must' or 'required' to describe something you are legally obliged to do. We use 'should' to recommend an action that will assist you to meet your legal requirements. We refer to the TGA as 'we' or 'us', and to sponsors as 'you'.

Biovigilance

Biovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other problem related to biologicals. Biovigilance for biologicals is analogous to pharmacovigilance for medicines and devices vigilance for medical devices. Biovigilance is part of Australia's therapeutic product vigilance system.

Role of the TGA

We have established vigilance systems for collecting and evaluating information relevant to the benefit-risk balance of all therapeutic goods, including biologicals. We continually monitor the safety profile of therapeutic goods available in Australia and take appropriate action where necessary.

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