European legislation: ATMP
Medicinal products for gene therapy fall under the European classification of medicinal products for advanced therapy (advanced therapy medicinal product; ATMP). There are three categories for medicinal products for advanced therapy:
- gene therapy medicinal products; GTMPs;
- somatic cell therapy medicinal products; sCTMPs;
- tissue engineered products; TEPs.
The definition of GTMPs is as follows: medicinal products for gene therapy contain a recombinant nuclein acid as active material; the activity is directly linked with the included recombinant nuclein acid sequence. The official definitions are given in Guideline 2009/120 (GTMPs and sCTMPs) and the European Regulation 1394/2007.
The legal framework for medicinal products for advanced therapy (ATMP) is laid down in the European Regulation 1394/2007. An overview of the European legislation, legal guidelines and guidances on various relevant subjects with regards to advanced therapies can be found at Advanced therapy medicinal products on the EMA website.