If you're planning to bring a faecal microbiota transplant (FMT) product to market in Australia, this is your starting point.
You must understand how we regulate FMT products and your obligations. This includes:
selecting the correct biological classification
preparing clinical and manufacturing evidence (if necessary)
complying with applicable standards.
Being well-prepared helps ensure your product meets Australian requirements and avoids regulatory delays.
Start by learning 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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PageUnderstand how we regulate faecal microbiota transplant (FMT) products.
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FormsProposal form for a new Approved Cell and Tissue Name (ACN)
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GuidanceGuidance about how we regulate biologicals that are packaged, or combined, with other therapeutic goods.
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GuidanceGuidance for sponsors of faecal microbiota transplant (FMT) products, which are regulated as biologicals.
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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.
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 for biologicals in relation to labelling.
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LegislationThis Therapeutic Goods Order constitutes a standard for faecal microbiota transplant 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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PageInformation about the approach that should be taken to risk management for biologicals.
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GuidanceGuidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.
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GuidanceThis guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in TGO 105.
Product types