Guidance

This guidance will help you understand our pharmacovigilance inspection program (PVIP).

Guidance on good manufacturing practice (GMP) compliance requirements for domestic and overseas manufacturers of medicines and biologicals.

Guidance for sunscreen manufacturers who must comply with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-13).

Guidance for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products.

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

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

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

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

Guidance on medical device application processing timeframes.

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.

How to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.

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

This guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in TGO 105.

Guidance to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.

Guidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.

Guidance for manufacturers and sponsors on the product standards that apply to haematopoietic progenitor cells (HPCs).

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

Guidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation.

Guidance on the documents that may be required to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including In Vitro Diagnostic medical devices (IVDs).

Guidance on preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).

Guidance about regulatory changes for software based medical devices, including software as a medical device (SaMD).

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

Guidance on regulatory requirements for Ahpra registered dental practitioners making and adapting personalised medical devices for patients.

Guidance on the format requirements for dossiers.