Biovigilance responsibilities of sponsors of biologicals

Australian requirements and recommendations

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13 December 2017

Introduction

This guidance concerns proposed amendments to the Therapeutic Goods Act 1989. The proposed amendments have not yet become law and may be subject to change. The purpose of this guidance is to make you aware of these proposed changes if/when they take effect.

Disclaimer

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 proposes amendments to the Therapeutic Goods Act 1989 (Act). The proposed amendments have not yet been passed by Parliament and may be subject to change. A link to the Bill can be found at: Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017.

Amendment regulations to support a number of measures in this Bill are proposed, but have also not yet become law as they rely on the Bill first being in place and on the Governor General's approval of the regulations. The purpose of this guidance is to inform stakeholders about these proposed changes. While reasonable care is taken to ensure that the information is an accurate description of the proposed changes, TGA does not guarantee or warrant the accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose. To the fullest extent permitted by law, including but not limited to under s 61A of the Act, TGA will not be liable for any loss, damage, expense or cost incurred or arising as a result of any use or reliance on this information.

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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