Introduction
Pharmacovigilance is defined by the World Health Organization as the science and activities related to detecting, assessing, understanding and preventing adverse effects and other medicine-related problems. The Therapeutic Goods Administration (TGA) collects and evaluates information related to the benefit-risk balance of medicines in Australia to monitor their safety and, where necessary, take appropriate action.
This guidance sets out the pharmacovigilance responsibilities of sponsors of medicines included on the Australian Register of Therapeutic Goods (ARTG) and regulated by the TGA. It outlines the mandatory reporting requirements and offers recommendations on pharmacovigilance 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’.
- Introduction
- Your regulatory reporting requirements
- Your record-keeping requirements
- Your pharmacovigilance system
- Pharmacovigilance and the law
- Other pharmacovigilance requirements