Site notifications

Sub menu

 

 

Industry guidance and resources

Understand your obligations and access resources to support your work. 

Find guidance and resources to:

  • learn about regulation basics
  • understand your legal obligations
  • support your work
  • keep updated with changes. 

Getting started

Learn about how we regulate and the regulatory pathway. 

Laws, Guidance and Guidelines

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

  • Legislation

    Find listed information for the 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.

Resources

Access helpful resources to support your work. 

  • Forms

    Therapeutic Goods Administration (TGA) forms.

  • Checklists

    Therapeutic Goods Administration (TGA) checklists.

  • Datasets

    Search the Australian Register of Therapeutic Goods (ARTG), and safety alerts, product shortages, approvals, and regulatory actions.

  • Decision trees

    Use decision trees to check rules for therapeutic goods in Australia, including classification, reporting obligations, advertising requirements and supply pathways.

  • User guide

    Find practical information to use systems, undertake tasks and complete processes for therapeutic goods regulation.

Changes and reforms

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.

  • Comment icon

    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.