Biological products that are exempt or excluded from TGA regulation

You need to check if your biological is:

Excluded from TGA regulation

Excluded goods are not subject to any of the requirements in the Therapeutic Goods Act 1989, including:

• good manufacturing practice
• inclusion on the Australian Register of Therapeutic Goods (ARTG)
• adverse event reporting
• compliance with TGA standards for therapeutic goods

The following biologicals are excluded goods:

• Eligible autologous human cells and tissues products
• Fresh viable human organs
• Fresh haematopoietic progenitor cells (HPCs)
• Reproductive tissue for assisted reproductive therapy

Eligible autologous human cells and tissues products

We will not regulate autologous HCT products if they meet all of the following criteria:

1. collected from a patient who is under the clinical care of a medical or dental practitioner registered under a law of a State or an internal Territory
2. manufactured by that medical or dental practitioner, or by a person or persons under the professional supervision of that medical or dental practitioner in a hospital (except storage and testing), for that patient who must be a patient of that hospital
3. not advertised to consumers

Where one or more criteria are not met, including advertising to consumers, regulation by TGA will apply.

These criteria are in the Therapeutic Goods (Excluded Goods) Determination 2018.

These biologicals are not regulated by us because the Government has decided that there is appropriate external regulation for them.

For more information on the exclusion of certain autologous HCT, including guidance on the terms used in the eligibility criteria, go to Autologous human cell and tissue products excluded from TGA regulation.

Fresh viable human organs

We do not regulate fresh viable human organs, or parts of human organs, for direct donor-to-host transplantation and used in accordance with applicable laws and standards.

The purpose of this item is to exclude organs for direct donor-to-host transplantation from the operation of the therapeutic goods legislation. It should be noted that only the organs are excluded from the definition of therapeutic goods. Equipment and material used for manufacturing may still be subject to regulation.

Fresh haematopoietic progenitor cells (HPCs)

We do not regulate fresh viable human haematopoietic progenitor cells (HPCs) for direct donor-to-host transplantation for the purpose of haematopoietic reconstitution.

Examples:

• bone marrow cells
• cord blood

The term 'haematopoietic progenitor cell' has been used deliberately. We no longer use the term 'bone marrow' to reflect current terminology and practice in the field of HPC transplantation.

Only the HPCs are excluded from the definition of therapeutic goods. Equipment and material used for manufacturing may still be subject to regulation.

Reproductive tissue for assisted reproductive therapy

Reproductive tissue for use in assisted reproductive therapy is not regulated by the TGA.

Examples of products that are excluded goods:

• sperm
• eggs
• embryos for in vitro fertilisation and other assisted reproductive technologies

This exclusion reflects the decision of the Australian Health Ministers' Conference in July 2008 that reproductive tissues should not be regulated by the TGA because use of these tissues was already coherently and consistently managed.