Australian Regulatory Guidelines for Biologicals (ARGB)
The ARGB will help you navigate the regulatory requirements for supplying and using biologicals in Australia. This includes regulation basics, application processes, post market responsibilities and more.
Last updated
Purpose
The Australian Regulatory Guidelines for Biologicals (ARGB):
- provides information on the supply and use of human cell and tissue-based therapeutic goods, and live animal cells, tissues and organs
- explains the legislative requirements outlined in the regulatory framework for biologicals, including specific biological standards.
Regulation basics
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GuidanceGuidance to help you understand which therapeutic goods will be regulated as a biological.
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PageUnderstand that not everything meeting our definition of a biological is regulated as a biological.
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GuidanceGuidance about how we regulate biologicals that are packaged, or combined, with other therapeutic goods.
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Definition typeView terms and acronyms commonly used in Australian therapeutic goods regulation, and their definitions. This list is intended for general informational purposes and is not exhaustive.
Classification
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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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GuidanceGuidance explaining how the method of preparation influences classification and whether autologous HCTs are eligible for exemptions.
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GuidanceGuidance to explain how the intended use of a biological product influences its classification and exemptions.
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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
Manufacturing
Applying for inclusion on the Australian Register of Therapeutic Goods (ARTG)
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GuidanceAn outline of the regulatory process and a summary of the requirements to successfully submit a biologicals application.
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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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GuidanceThis guidance outlines the information needed in your dossier for us to be able to effectively review your application for a biological therapeutic good.
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GuidanceGuidance on the stages of preparing and submitting an application for inclusion of a Class 2, 3 or 4 biological in the ARTG.
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Applying for a Class 1 biological to be added in the Australian Register of Therapeutic Goods (ARTG)
GuidanceGuidance for preparing and submitting an application for inclusion of a Class 1 biological on the ARTG. -
User guideThis form is used to include a new biological or vary an existing biological on the ARTG
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GuidanceRisk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form.
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PageMedicines and other therapeutic goods must comply with applicable standards to be supplied in Australia.
Biologicals priority determination
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PageInformation on the stages of preparation, and application for Class 2, 3 or 4 biologicals using priority pathway.
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GuidanceGuidance for biological sponsors on the eligibility criteria and supporting documents required for priority determination applications
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GuidanceThis guidance is for sponsors intending to use the priority review pathway for biologicals.
Autologous human cells and tissues (HCT) products
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GuidanceGuidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation.
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GuidanceGuidance to help work out if your autologous HCT product is excluded from our regulation.
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GuidanceGuidance to help work out if your autologous HCT product is exempt from some aspects of our regulation.
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GuidanceGuidance to determine the level of regulation of PRP, PRF or conditioned serum products for therapeutic use.
Unapproved biologicals
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Accessing unapproved biologicals that are not on the Australian Register of Therapeutic Goods (ARTG)
GuidanceGuidance for people who want to access biologicals that are not included on the Australian Register of Therapeutic Goods (ARTG).
Post-market responsibilities
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GuidanceGuidance for sponsors or suppliers of biologicals in Australia on their ongoing responsibilities after a product is included on the Australian Register. of Therapeutic Goods (ARTG).
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GuidanceThis guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a biological
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GuidanceGuidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.
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GuidanceThis guidance is for all sponsors of products regulated as biologicals.
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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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GuidanceGuidance about how to promote your business and service, without advertising biologicals to the public.
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GuidanceRelease on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient. Access to the request form and instructions are within the guidance document.
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GuidanceGuidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.
Biologicals standards
Therapeutic Goods Orders
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LegislationThis Therapeutic Goods Order constitutes a standard for faecal microbiota transplant products.
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LegislationThis Therapeutic Goods Order constitutes a standard for biologicals in relation to labelling.
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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.
Guidance on Therapeutic Goods Orders
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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 108: Requirements around the minimisation of transmission of communicable diseases for therapeutic goods containing biologicals and human cell or tissue (HCT).
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GuidanceGuidance on TGO 109: Standards for Biologicals - General and Specific Requirements.
Faecal Microbiota Transplant (FMT) products
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GuidanceThis guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in TGO 105.
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GuidanceGuidance for sponsors of faecal microbiota transplant (FMT) products, which are regulated as biologicals.
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PageUnderstand how we regulate faecal microbiota transplant (FMT) products.
Business services
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PageApply for access and manage your account details.
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User guideQuestions and answers for drafters/submitters
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PageFind out about fees and charges that apply from January 2025