Therapeutic Goods Administration (TGA)

Acronym
TGA
Type
Standards Development Organisation

Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government and responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. They regulate medicines, medical devices and biologicals that are used in the Australian healthcare system.

The TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the administration of medication, must be approved by the TGA and registered in the Australian Register of Therapeutic Goods. As part of their role as regulator, the TGA create regulatory standards that support the safety of therapeutic goods within Australia for the benefit of consumers and patients. Their development of these regulatory standards involves consultation with stakeholders within the process, with final decisions being made within the TGA along with the Federal Health department and ministry.  

Find out more about TGA Guidance and Resources.

Resources

Digital tools and medical devices v1.0

Category
Guidance Document
Organisation
TGA
Type
Standard
Version
1
Access
Open
Status
Active
Updated
May 2023
This document provides guidance for the mental health sector about when their digital tools, aids, apps and products, including internet-based services, may be regulated as medical devices by the TGA.

Electronic Instructions for Use – eIFU v1.0

Category
Guidance Document
Organisation
TGA
Type
Standard
Version
1
Access
Open
Status
Active
Created
Aug 2018
This guideline aims to support manufacturers and sponsors who supply instructions for use of their medical devices in an electronic or online format.

Medical device cyber security information for users v1.2

Category
Guidance Document
Organisation
TGA
Type
Standard
Version
1.2
Access
Open
Status
Active
Updated
Nov 2022
This document describes cyber security practices and protocols for the medical device sector and aims to help medical device users manage cyber security risk.

Medical device patient information materials: a fact sheet for health professionals

Category
Supplementary Resource
Organisation
TGA
Type
Standard
Access
Open
Status
Active
Updated
May 2023
This fact sheet for health professionals discusses providing patients with information about their medical devices. It discusses who is responsible for providing patient information leaflets (PILs) and patient implant cards (PICs) to patients, and when they should be supplied.

Medicine labels: Guidance on TGO 91 and TGO 92 v2.3

Category
Supplementary Resource
Organisation
TGA
Type
Standard
Version
2.3
Access
Open
Status
Active
Created
Mar 2021
This document provides extensive guidance for medicine labelling rules TGO 91 and TGO 92. It clarifies and elaborates on the mandatory requirements and provides best practice recommendations for medicine labels.

Regulation of software based medical devices

Category
Guidance HTML
Organisation
TGA
Type
Standard
Access
Open
Status
Active
Updated
Jul 2024
This document provides information on the regulation in Australia for software and apps which meet the legislated definition of a medical device. It helps manufacturers and sponsors understand how the Therapeutic Goods Administration (TGA) interprets requirements, and how they can comply with the regulations.

Regulatory basics on medical devices for health practitioners v1.0

Category
Guidance Document
Organisation
TGA
Type
Standard
Version
V 1.0
Access
Open
Status
Active
Created
Mar 2024
This guidance is for Australian health practitioners who manufacture, supply and use medical devices. It helps them identify whether their devices are regulated by the Therapeutic Goods Administration (TGA) and it also advises how to comply with the requirements of the therapeutic goods legislation.

Standard for serialisation and data matrix codes on medicines v1.0

Category
Supplementary Resource
Organisation
TGA
Type
Standard
Version
V 1.0
Access
Open
Status
Active
Created
Mar 2021
This guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes. It describes the requirements in the Therapeutic Goods (Medicines – Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021.

Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines

Category
Standard
Organisation
TGA
ID
F2023C00458 (C03)
Type
Standard
Access
Open
Status
Active
Created
Apr 2023
This document sets out the labelling requirements for prescription medicines and composite packs containing a subscription medicine. It includes general labelling requirements, information that must be present, information that must be on the main label, and exemptions from the labelling requirements.

Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines vC02

Category
Standard
Organisation
TGA
ID
F2023C00456 (C02)
Type
Standard
Version
C02
Access
Open
Status
Active
Created
Apr 2023
This document sets out the labelling requirements for non-prescription medicines. It includes general labelling requirements, information that must be present, information that must be on the main label, and exemptions from the labelling requirements.

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