Guidance

Guidance to explain how the intended use of a biological product influences its classification and exemptions.

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.

Guidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.

Guidance about the regulation of sport supplements in Australia for importers and sellers.

Guidance on how to request early scientific advice on a biowaiver justification.

How the TGA assesses the safety of materials derived from human and other animal species, naturally susceptible to TSE, that are used in the manufacture of therapeutic goods.

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

This guidance outlines ARTG and Conformity Assessment procedures for immunohaematology reagents (IHRs) requirements, that manufacturers and sponsors need to know.

Guidance on clinical performance requirements and risk mitigation strategies.

Guidance on changing information in the ARTG for listed or assessed listed medicines.

Guidance on medical device application processing timeframes.

Guidance about how we regulate biologicals that are packaged, or combined, with other therapeutic goods.

Guidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).

Guidance on how we make use of assessments from comparable overseas regulators (CORs).

Guidance for people who want to access biologicals that are not included on the Australian Register of Therapeutic Goods (ARTG).

This guidance is to assist health practitioners understand their requirements when prescribing ‘unapproved’ therapeutic goods for an individual patient using the Special Access Scheme (SAS).

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

This guidance helps sponsors and manufacturers of ‘unapproved’ therapeutic vapes understand quality and safety requirements, under the Therapeutic Goods (Medical Device Standard —Therapeutic Vaping Devices) Amendment Order 2024.

Guidance on the quality and labelling requirements of Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO 110) Instrument 2024.

This guidance provides information about preparing Consumer Medicine Information (CMI) documents that comply with current regulations.

Guidance to help you understand which therapeutic goods will be regulated as a biological.

This guidance provides for a nationally uniform approach to retail storage of Schedule 6 and Schedule 7 poisons.

Guidance to help manufacturers and sponsors navigate packaging terms across the industry, to meet regulatory requirements.

Guidance to determine the level of regulation of PRP, PRF or conditioned serum products for therapeutic use.

Guidance detailing self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.