Guidance

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

Guidance on clinical performance requirements and risk mitigation strategies.

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

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.

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

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 on medical device application processing timeframes.

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

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.

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

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 for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.

Guidance for the requirements applicable to medical devices containing poisons.

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

Guidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13.

Guidance for sponsors of COVID-19 IVDs about their ongoing obligations

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

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.

This guidance helps providers of digital mental health services or products to understand their regulatory obligations.

Guidance on our expectations concerning clinical performance requirements and risk mitigations for in vitro diagnostic medical devices intended to be used as self-tests for chlamydia, gonorrhoea and syphilis.

Guidance explaining how to find out which statements (if any) are required by the RASML for a particular over-the-counter (OTC) or complementary medicine.