The Therapeutic Goods Administration (TGA) in Australia regulates therapeutic goods such as medications, medical devices, and diagnostic tests in Australia.

The TGA, much like the United States Food and Drug Administration (US FDA), develops regulations and guidelines to ensure that manufacturers work safely, maintain the required ethical standards, and are held accountable for any issues that may arise in the manufacturing process, thereby safeguarding public health and welfare.

Responsibilities of the TGA

The key roles and responsibilities of the TGA are as follows:

  • As mentioned at the outset, the TGA regulates therapeutic goods in Australia, including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, and blood and blood products.
  • The TGA is in charge of regulating the supply, import, export, production, and advertising of therapeutic goods.
  • The TGA is in charge of enforcing the Therapeutic Goods Act of 1989, which governs the quality, safety, and efficacy of medications as well as access to medicines that have not been licensed for general use (that is, unapproved therapeutic goods).
  • The TGA is in charge of issuing Australian manufacturing permits, international production certifications, and clearances.
  • The TGA regulates therapeutic goods through pre-market assessment, post-market monitoring, and standard enforcement procedures. It also licenses Australian manufacturers, ensuring that overseas manufacturers adhere to the same standards as their Australian counterparts.

The TGA has established stringent requirements for a drug to register in Australia.

Are you seeking to achieve compliance with TGA regulations? Seek assistance from an experienced Regulatory service provider like Freyr. Contact our experts today to get support with challenges in the drug registration process in Australia.