European legislation: ATMP
Advanced therapy medicinal products (ATMPs) are gene therapy, somatic cell therapy, tissue-engineered products, or a combination thereof. European legislation applies to research with ATMPs.
There are three categories of ATMP's:
- gene therapy medicinal products (GTMPs);
- somatic cell therapy medicinal products (sCTMPs);
- tissue-engineered products (TEPs).
The Legal framework for ATMPs is laid down in the European Regulation 1394/2007. An overview of the European legislation on various relevant subjects regarding ATMPs can be found at Advanced therapy medicinal products on the website of the EMA.