To ensure the quality of listed medicines in Australia, each step of the manufacturing process must be completed by a licensed manufacturer. These steps include:

  • production
  • processing
  • assembling
  • packaging
  • labelling
  • storage
  • sterilising
  • testing
  • release for supply.

Australia has adopted the PIC/S Guide to Good Manufacturing Practice (GMP), which describes the principles and procedures that need to be followed to ensure the quality of medicines. Sponsors need to ensure that their medicines are only manufactured in approved, GMP-compliant facilities. Australian manufacturers must hold a license for each of the steps that they undertake. Overseas manufacturers have to meet an acceptable GMP standard and be certified.

A list of Australian approved manufacturers can be found on the TGA eBS website. Click Public TGA Information > Australian Manufacturers to see the full list.

Follow the links below to learn more about your regulatory requirements:

Regulation basics

Eligibility for listing – what does that mean?

What is the Therapeutic Goods (Permissible Ingredients) Determination?

What do I need to know about the Advertising Code?

Which standards do I need to comply with?