Advanced therapies

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

      AND

   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

• Regulation of advanced therapies
• Presentation: GMP for new and emerging technologies: Advanced Therapy Medicinal Products (ATMPs)