Approval of biological medicines

Scientists working in a medical laboratory

Australia has a strong regulatory system that ensures the safety, effectiveness and quality of all medicines, including biological medicines. The regulatory system is managed by the Therapeutic Goods Administration (TGA), which is part of the Australian Government Department of Health.

The TGA regulates every step involved in the production and use of medicine in Australia:

  • Before any medicine, including a biosimilar medicine, is registered and allowed on the market, it must undergo thorough testing and evaluation
  • All medicine manufacturers must comply with strict standards that ensure product safety, quality and consistency
  • The TGA monitors the safety of all medicines, including biosimilar medicines, used in Australia. If there is a risk to Australians from any medicine, the TGA takes action to address this risk.