Guidance

Guidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.

Guidance on how to comply with the quality standards for MDMA (TGO 112) and psilocybine (TGO 113).

Guidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.

Guidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).

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

Guidance for sponsors about how to apply for orphan drug designation for a prescription medicine.

Guidance on submitting the CPD for prescription medicines.

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

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

Guidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.

Guidance about the process of applying for a priority determination, which is the first step of the priority review registration pathway.

Guidance for the deletion of commercially confidential and personal information in an Australian Public Assessment Report (AusPAR).

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

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

Guidance on medical device application processing timeframes.

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

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

Guidance on whether medicines are evaluated as prescription medicines or complementary or over-the-counter (OTC) medicines.

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

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

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