Biologicals

Find out how we define biologicals and how we regulate them.

Last updated

18 December 2024

About biologicals

Products that are regulated as biologicals include:

tissue-based products (skin, bone, ocular, cardiovascular, amnion)
cell-based products (genetically modified, in vitro cell expansion or depletion)
immunotherapy products containing human cells
combination products (for example, cell therapy and medical device)
products that comprise or contain live animal cells, tissues or organs (for example, pancreatic islet cells isolated from pigs)
autologous human cells and tissue products (including stem cells)
faecal microbiota transplant (FMT) products (a thing that comprises, contains or is derived from human stool).

For detailed information on how we define and regulate biologicals go to What is regulated as a biological.

More information

Regulatory framework for biologicals

17 August 2020

Page

Understand how we regulate human tissue and cell-derived products and live animal cell, tissues or organs in Australia.
Inclusions of new biologicals

12 October 2021

Page

How we include new biologicals in the Australian Register of Therapeutic Goods (ARTG).
Accessing unapproved biologicals that are not on the Australian Register of Therapeutic Goods (ARTG)

1 October 2024

Guidance

Guidance for people who want to access biologicals that are not included on the Australian Register of Therapeutic Goods (ARTG).
Determining if a biological product is for homologous use

3 October 2024

Guidance

Guidance to explain how the intended use of a biological product influences its classification and exemptions.
Human placenta ingestion

19 January 2018

Page

Understand the potential health risks and legal implications for placenta consumption.

Faecal microbiota transplant

Supplying faecal microbiota transplant (FMT) products as biologicals

11 October 2024

Guidance

Guidance for sponsors of faecal microbiota transplant (FMT) products, which are regulated as biologicals.
Faecal microbiota transplant products regulation

4 August 2023

Page

Understand how we regulate faecal microbiota transplant (FMT) products.

Product types

Latest articles

What’s changed on the website

30 October 2025

News articles

We have made changes to our website to make finding information easier. These improvements are based on your feedback.
Website changes coming soon for industry users

22 October 2025

News articles

We’re pleased to announce that improvements for industry users will roll out by the end of October.
Adoption of International Scientific Guidelines in Australia

29 May 2025

News articles

Following a public consultation process , the TGA has adopted the following 19 international scientific guidelines.

Latest publications

ACMD meeting statement, Meeting 84, 10 April 2025

5 May 2025

Meeting statements

Read the meeting statement from the meeting of the Advisory Committee on Medical Devices.
ACMD meeting statement, Meeting 82, 12 December 2024

14 January 2025

Meeting statements

Read the meeting statement from 12 December 2024 meeting of the Advisory Committee on Medical Devices.

Latest consultations

Consultation: Provisions to regularise the Technical Master File (TMFs) and Type II Plasma Master File (PMFs) processes

11 November 2025

Consultation

We are seeking industry feedback on proposed amendments to strengthen the legal framework governing TMFs for blood and blood components, and PMFs for Type II plasma-derived products.
Consultation: Adoption of International Scientific Guidelines in Australia R01-2024

16 January 2025

Consultation

We are seeking feedback on whether 19 international scientific guidelines should be adopted.
Consultation: Reforming Australia’s Therapeutic Goods Testing Regulations

18 August 2024

Consultation

Have your say on potential reforms to Part 5 of the Therapeutic Goods Regulations 1990.

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