Industry guidance and resources

Understand your obligations and access resources to support your work.

Find guidance and resources to:

Getting started

Learn about how we regulate and the regulatory pathway.

Regulation essentials

A general introduction to therapeutic goods regulation in Australia.
TGA Learn

Learn how to navigate the regulatory pathway.

Understand your legal obligations by looking at legislation and Guidance. Explore compositional, scientific and regulatory guidelines.

Legislation

This page lists legislation that is referred to in our Guidance content.
Guidance

Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
Compositional guidelines

Access a list of ingredients permitted for use in listed medicines that have a TGA compositional guideline.
Australian Regulatory Guidelines (ARGs)

The ARGs group together resources about regulatory requirements for biologicals, medical devices and medicines.
International scientific guidelines adopted in Australia

Access a list of international guidelines that have been adopted in Australia before manufacturing and supplying your medicine or biological.

Access helpful resources to support your work.

Corporate reports

Find corporate reports, plans, statements, and stakeholder surveys.
Forms

Therapeutic Goods Administration (TGA) forms.
Checklists

Therapeutic Goods Administration (TGA) checklists.
Datasets

View a list of all datasets available to search
Decision trees

Use our decision trees to work out classifications, advertising and manufacturing questions, and product types.

Keep up with what's new and reforms. Have your say in consultations.

What's new

Find all our recently published information in one place.
Consultations

Search open and closed consultations on the way we regulate medicines, medical devices and biologicals.
TGA reforms

Information on our regulatory and business process reforms.