Biological medicines
Therapeutic Goods Administration (TGA) biological medicines content.
Biological medicines are regulated as prescription medicines in Australia.
Biological medicine means:
- a medicine (other than an antibiotic) that is:
- a vaccine, a peptide, a protein, a polysaccharide; and
- derived from a human, animal or other organism, or produced through recombinant technology or biotechnology; and
- of a kind specified in item 1 of Part 1 of Schedule 10; or
but does not include a 'biological' within the meaning of section 32A of the Therapeutic Goods Act 1989 (the Act).
The Act requires that medical products imported into, supplied in, or exported from Australia be in the Australian Register of Therapeutic Goods (ARTG). In order for a prescription medicine to be in the ARTG, a sponsoring company is required to submit an application to the TGA. A submission to register a prescription medicine consists of:
- data that support the quality, safety and efficacy of the product for its intended use,
- completed forms, and
- the payment of fees.
For details on how to access prescription medicines and how we regulate them, go to Prescription medicines.
Latest guidance
-
Release 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.
-
Applying for a Class 1 biological to be added in the Australian Register of Therapeutic Goods (ARTG)
Guidance for preparing and submitting an application for inclusion of a Class 1 biological on the ARTG. -
Australian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.