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.
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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.
Resources
Access helpful resources to support your work.
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Decision trees
Use decision trees to check rules for therapeutic goods in Australia, including classification, reporting obligations, advertising requirements and supply pathways.
