3. Underpinning Knowledge - Legislation and Professional Issues

3.3.13Advanced therapy medicinal products (ATMPs)

An advanced therapy medicinal product (ATMP) is a biological medicinal product based on genes, tissues or cells which is either:

  • a gene therapy medicinal product
  • a somatic cell therapy medicinal product, or
  • a tissue engineered product

In addition, some ATMPs may contain one or more medical devices as an integral part of the