Understanding which therapeutic goods are regulated as biologicals

Products that are regulated as biologicals include, but are not limited to:

• 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 (e.g. cell therapy and medical device)
• products that comprise or contain live animal cells, tissues or organs (e.g. 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).

How we define biologicals

For your product to meet our definition of a biological, it must be:

• a thing made from, or that contains, human cells or human tissues, and that is used to:
  • treat or prevent disease, ailment, defect or injury
  • diagnose a condition of a person
  • alter the physiological processes of a person
  • test the susceptibility of a person to disease
  • replace or modify a person's body parts
• faecal microbiota transplant products
• a thing that comprises or contains live animal cells, tissues or organs.

How we regulate biologicals

Even though your product may meet the definition of a biological, it may not be regulated as a biological.

You need to check if your biological is:

• excluded from TGA regulation
• products regulated as a therapeutic good, but not as a biological
• products regulated as biologicals.

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 Register
• adverse event reporting
• compliance with TGA standards for therapeutic good.

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.

These products are excluded from regulation under the Therapeutic Goods Act 1989 by reference in the Therapeutic Goods (Excluded Goods) Determination 2018.

Equipment used in manufacturing

Even though your biological may be excluded from our regulation, equipment and materials used for the manufacture of the product may be therapeutic goods to which therapeutic goods legislation applies and may be subject to regulation by us. For example, IVF solutions are regulated as a medical device.

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 Excluded autologous human cell and tissue products.

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.

Products regulated as a therapeutic good, but not as a biological

Some products, even though they meet the definition of a biological are:

• regulated by us as therapeutic goods
• not regulated as biologicals.

The Secretary can declare specific therapeutic goods to either be or not be biologicals.

Things that are not biologicals

The following goods are declared not to be biologicals:

• biological medicines (regulated as prescription medicines):
  • vaccines (that do not contain viable human cells)
  • recombinant products
  • plasma derived products (or that contain plasma derived products)
• blood and blood components, regulated as medicines under the Therapeutic Goods
  (Manufacturing Principles) Determination 2020:
  • blood means whole blood collected from a single human donor and processed either for
    transfusion or further manufacturing
  • blood components means therapeutic components of blood (red cells, white cells,
    platelets, plasma) that can be prepared by centrifugation, filtration and freezing, but
    not including haematopoietic progenitor cells
• HPCs used for haematopoietic reconstitution, regulated as medicines under the Therapeutic Goods (Manufacturing Principles) Determination 2020:
  • HPCs mean self-renewing or multipotent stem cells, or both, capable of maturation into
    haematopoietic lineages, lineage-restricted pluripotent progenitor cells, or committed
    progenitor cells
  • includes HPCs derived from cord blood
• in vitro diagnostic devices (IVDs)
• samples of human cell or tissue that are solely for diagnostic purposes in the same individual.

Products regulated as biologicals

For your product to be regulated as a biological it must:

• be a therapeutic good (as defined in the Therapeutic Goods Act 1989)
• either meet the definition of a biological or be specified by legislative instrument to be a biological.

Your product will not be regulated as a biological if it is:

• an excluded good
• regulated as a therapeutic good, but not as a biological.

If your product is regulated as a biological, pathways to supply biologicals will explain the levels of regulation applied.