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.
More information
Latest articles
- Pharmacovigilance Inspection Program Risk Assessment SurveyThe Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.
Latest publications
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2021The TGA Pharmacovigilance Inspection Program (PVIP) metrics report for 2021 is now available.
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2020The PVIP aims to strengthen and broaden the TGA's post-market monitoring activities and protect public health
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2019In 2019, the TGA conducted 10 pharmacovigilance inspections of Australian medicine sponsors