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Advanced therapies

Find out how we define and regulate advanced therapies, which include gene, cell and tissue treatments.

Advanced therapies or advanced therapy medical products is a term used to describe innovative therapies. International regulators use this term to include gene, cell and tissue therapies.

The TGA uses the following definition for advanced therapies:

  1. Gene therapies
    1. the substance is used in or administered to human beings to regulate, repair, replace, add or delete a genetic sequence


    2. the substance is involved in the therapeutic, prophylactic, or diagnostic effect of the product
  2. Gene modified cell therapies
  3. Cell and tissue therapies that:
    1. are not devices
    2. have been classified as class 3 or 4 biologicals.
  4. Either a or b in combination with a device

Key information

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