European legislation: ATMP

The majority of cellular products fall under the European classification of medicinal products for advanced therapies (advanced therapy medicinal product; ATMP). There are three categories for medicinal products for advanced therapy:

  1. gene therapy medicinal products; GTMPs;
  2. somatic cell therapy medicinal products; sCTMPs;
  3. tissue engineered products; TEPs.

The definition of somatic cell therapy medicinal products (sCTMPs) is: Medicinal product for somatic cell therapy: existing of cells or tissues which are essentially manipulated or of cells or tissues not intended to perform the same task in the recipient as in the donor. The definition of TEPs (tissue engineerd products) is: tissue manipulation products made up of manipulated cells or tissues for regeneration, repair or replacement of human tissue. The official definitions are given in the Directive 2009/120 and the European Regulation 1394/2007.

The Legal framework for medicinal products for advances therapy (ATMP) is laid down in the European Regulation 1394/2007. An overview of the European legislation on various relevant subjects with regards to advanced therapies can be found at Advanced therapy medicinal products on the website of the EMA.