To legally supply human cell and tissue products in Australia, you must apply to include them in the Australian Register of Therapeutic Goods (ARTG).
Submit your application through our Business Services Portal. You’ll need to provide evidence that your product meets safety, quality, and efficacy standards. Supporting documents and fees are required.
Good preparation helps ensure compliance and smooth market entry.
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.
Application pathways and processes
Find application routes to market approval.
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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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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. -
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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PageThe ARGB will help you navigate the regulatory requirements for supplying and using biologicals in Australia.
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User guideThis form is used to include a new biological or vary an existing biological on the ARTG
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GuidanceGuidance for biological sponsors on the eligibility criteria and supporting documents required for priority determination applications
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PageOverview of the process to follow if you want to supply therapeutic goods in Australia
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PageUnderstand that not everything meeting our definition of a biological is regulated as a biological.
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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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PageInformation on the stages of preparation, and application for Class 2, 3 or 4 biologicals.
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FormsFind out what process to follow if a product is manufactured using a human embryo or a human embryonic stem cell, or any material sourced from such an embryo or stem cell.
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GuidanceThis guidance is for sponsors intending to use the priority review pathway for biologicals.
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GuidanceGuidance to help sponsors understand the process of submitting a priority inclusion application.
Pre-submission planning
Access requirements for pre-submission planning and meetings.
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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. -
PageThe ARGB will help you navigate the regulatory requirements for supplying and using biologicals in Australia.
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GuidanceGuidance for manufacturers in the development of Technical Master Files (TMF) relevant to blood, blood components and haematopoietic progenitor cells.
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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.
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GuidanceGuidance to help sponsors understand the process of submitting a priority inclusion application.
Fees and charges
Understand fees, exemptions and how to make payments.
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PageInformation about annual charges for product entries on the Australian Register of Therapeutic Goods (ARTG) and manufacturing licences.
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PageThe following forms are for the use of sponsors and manufacturers mainly regarding the payment of fees and charges.
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PageAccess to information about fees and payments.
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PageLearn about eligibility, declaration requirements, and compliance obligations for the ACE scheme.
Dossier preparation
Learn how to prepare and submit your dossier.
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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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FormsComplete this form when submitting a new DMF to TGA, or when updating an existing DMF already held by the TGA.
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FormsUse this form when submitting an updated RMP after regulatory approval
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PageThis page is for industry stakeholders (e.g. manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA
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PageHow to submit applications, reports and documentation in the electronic common technical document (eCTD) and non-eCTD electronic submission (NeeS) formats.
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PageInformation on submitting your application and dossier for biologicals.
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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.
Product changes and variations
Access information to vary products and sponsorship.
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GuidanceGuidance for what to do if the sponsor of a therapeutic good changes.
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PageThis guidance is for sponsors of biologicals included in the Australian Register of Therapeutic Goods who want to make a change to that biological (parent biological) where the change creates a separate and distinct good (new biological)
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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
Product types