The TGA's risk management approach
The TGA's role is to develop and implement appropriate national policies and controls for medicines, medical devices, blood, blood products and tissues.
In undertaking its regulatory roles, the TGA adopts a risk management approach by identifying, analysing, evaluating and treating the risks posed by medicines, medical devices, blood, blood products and tissues.
It is intended that this document will be updated on an ongoing basis.
Risk management approach to the regulation of therapeutic goods
The TGA's risk management approach to the regulation of therapeutic goods is available below. This document describes the TGA's role in the management of risks associated with medicines, medical devices, blood and tissues.
The document also provides details of how the TGA communicates both internally and with external stakeholders on risk management issues.
Contents
- Glossary of terms and acronyms used
- Chapter 1: Introduction
- Chapter 2: Background information about risk assessment and risk management
- Chapter 3: Establishing the context for risk assessment by the TGA
- Chapter 4: Identifying, analysing, evaluating and treating the risks posed by therapeutic goods
- Chapter 5: Monitoring and review
- Chapter 6: Enforcement action
- Chapter 7: Communication and consultation
- Chapter 8: Summary