After your biological product is on the market you have ongoing responsibilities.
You must:
manage your biological’s inclusion in the Australian Register of Therapeutic Goods (ARTG)
notify us of any changes or variations to your product
pay regulatory charges
monitor safety
report issues
support post-market surveillance.
We oversee these activities to protect public health and ensure biologicals remain safe and effective in Australia. Understanding your responsibilities helps you stay compliant and manage risks throughout your product’s life.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information about biologicals, and specific types of biologicals. You may also have to meet obligations that apply to all products
Monitoring and reporting
Find sponsor obligations for ongoing monitoring and reporting.
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GuidanceThis guidance is for all sponsors of products regulated as biologicals.
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User guideElectronic data interchange for ICSR submission using the E2B R2 format
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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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PageRecall coordinators play an important part in the market action process.
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PageRegulatory decisions and notices for biologicals
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PageReport counterfeit products, suspicious or illegal activity, or make a complaint about non-compliant advertising.
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PageFind out how to report an adverse event, including side effects from taking medicines and problems with medical devices.
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ServiceUse this portal to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good.
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PageAs the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events.
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PageSummarises the roles and responsibilities of key stakeholders in clinical trial safety reporting of significant safety issues (SSIs) and urgent safety measures (USMs).
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PageLearn about our approach to minimising the transmission of TSEs (Transmissible Spongiform Encephalopathies).
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PageBatch release testing of biological medicines (excluding vaccines) is no longer required.
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PageInformation on the TGA Laboratories testing program for therapeutic goods.
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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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Compliance
Learn how we ensure compliance, including post-market reviews.
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PageKnow the ways we respond to breaches such as warnings, fines and legal action.
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PageFind out how we approach and manage compliance with therapeutic goods regulation in Australia.
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PageRead about our new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 2023 to 2025.
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PageInformation about therapeutic goods cancelled at the request of the sponsor.
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PageInformation about how the TGA uses and calculates the value of infringement notices
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GuidanceGuidance for making an offer of enforceable undertaking to us.
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PageWatch this video for an overview of the TGA compliance framework.