If you're planning to bring a human cell and tissue (HCT) product to market in Australia, this is your starting point.
You must understand how we regulate these biologicals and your obligations at each stage. This includes selecting the correct classification, preparing evidence, and complying with applicable standards such as donor screening.
Being well-prepared helps ensure your product meets Australian requirements and avoids regulatory delays.
Start by learning about your responsibilities and planning each stage of your product’s lifecycle.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to biologicals. You may also have to meet obligations that apply to all biologicals and all products.
General information
Learn about how products are regulated.
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PageAll biologicals must be classified before they can be included on the Australian Register of Therapeutic Goods (ARTG).
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PageOverview of the way we consider risks and benefits during the evaluation and post-market monitoring of products.
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GuidanceGuidance on our approved terminology for medicines.
Definitions and classification
Understand how products are defined and classified.
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PageFind out if your biological product is regulated as a different type of therapeutic good.
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PageFind out if your biological product is exempt or excluded from TGA regulation.
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GuidanceAustralian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.
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PageConfirm your product is regulated as a biological.
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GuidanceGuidance to explain how the intended use of a biological product influences its classification and exemptions.
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GuidanceGuidance to help determine whether products are separate and distinct biologicals that will need to be included as separate ARTG entries.
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FormsProposal form for a new Approved Cell and Tissue Name (ACN)
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FormsUse this form to apply for an Approved Biological Name.
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PageCovers a subtype of xenotransplant products involving contact with live animal tissues outside the patient's body.
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GuidanceGuidance about how we regulate biologicals that are packaged, or combined, with other therapeutic goods.
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GuidanceGuidance explaining how the method of preparation influences classification and whether autologous HCTs are eligible for exemptions.
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GuidanceGuidance to help you understand which therapeutic goods will be regulated as a biological.
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PageTherapeutic goods can comprise a broad range of things, such as bandages, pregnancy testing kits, herbal remedies, tissue grafts and paracetamol.
Ingredients and scheduling
Get information about ingredient approvals and scheduling requirements.
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PageUnderstand what ingredient requirements apply to your therapeutic good.
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PageInformation on proposing a new ingredient name to be included on the approved list.
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User guideHow to search TGA business services for approved ingredients and accepted TGA terminology.
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GuidanceGuidance on the regulatory requirements for therapeutic goods that contain, or are produced from, human blood or plasma.
Legislation, Acts and Orders
Review the laws and legal orders that regulate therapeutic goods.
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PageFind information about legislation, acts and regulations, legislative instruments and other legislative information.
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PageUnderstand how we regulate human tissue and cell-derived products and live animal cell, tissues or organs in Australia.
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LegislationThis Instrument makes various amendments to the Therapeutic Goods Advertising Code.
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LegislationThis Determination specifies the information that must accompany an application to include a therapeutic good that is a biological in the Australian Register of Therapeutic Goods (ARTG).
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LegislationThese Rules specify circumstances where a health practitioner is authorised to supply specified therapeutic goods that are biologicals which are not included in the Australian Register of Therapeutic Goods (ARTG), under the TGA's Special Access Scheme category C pathway.
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LegislationThis Determination sets out standard conditions for the inclusion of biologicals in the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis Instrument specifies whether certain things are or are not biologicals for the purposes of the Therapeutic Goods Act 1989.
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LegislationThe Therapeutic Goods (Charges) Act 1989 regulates the fees associated with the registration and listing of therapeutic goods in Australia.
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LegislationThis Determination specifies goods that are excluded from regulation for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis Specification facilitates the public release of specified therapeutic goods information relating to exemptions that do or do not apply under the Annual Charges Exemption Scheme.
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LegislationThis Specification facilitates the open publication of certain kinds of therapeutic goods information relating to ingredients of medicines and components of biologicals in the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis Therapeutic Goods Order constitutes a standard in relation to therapeutic goods that are haematopoietic progenitor cells derived from cord blood.
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LegislationThis Therapeutic Goods Order constitutes a standard for biologicals in relation to labelling.
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LegislationThis Therapeutic Goods Order constitutes a standard for faecal microbiota transplant products.
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LegislationThe Order establishes mandatory requirements for the screening of donors of human cell and tissue products in Australia to ensure the safety, quality, and efficacy of these products for therapeutic use.
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Therapeutic Goods (Standards for Biologicals—General and Specific Requirements) (TGO 109) Order 2021
LegislationThis Therapeutic Goods Order sets out general and specific requirements relating to all biologicals, human musculoskeletal tissue products, human cardiovascular tissue products, human ocular tissue products, human skin products and human amnion products.
Standards and requirements
Understand product obligations for safety, quality and efficacy.
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PageThe Code applies to blood, human tissues and human cellular therapy products manufacturers.
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PageThe ARGB will help you navigate the regulatory requirements for supplying and using biologicals in Australia.
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GuidanceGuidance on providing adventitious agent safety information in applications for medicines containing, or manufactured using, materials of animal or human origin.
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PageHow we include new biologicals in the Australian Register of Therapeutic Goods (ARTG).
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PageCovers a subtype of xenotransplant products involving contact with live animal tissues outside the patient's body.
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FormsThis form guides you through the classification of biologicals and captures sufficient information about your product for us to provide advice
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PageInformation about the approach that should be taken to risk management for biologicals.
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GuidanceHow the TGA assesses the safety of materials derived from human and other animal species, naturally susceptible to TSE, that are used in the manufacture of therapeutic goods.
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GuidanceGuidance for manufacturers and sponsors on the product standards that apply to haematopoietic progenitor cells (HPCs).
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GuidanceGuidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.
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GuidanceGuidance on TGO 109: Standards for Biologicals - General and Specific Requirements.
Product types