Advanced-therapy medicinal products (ATMPs) are medicines for human use that are based on gene therapy, somatic-cell therapy or tissue engineering. They offer groundbreaking new opportunities for the treatment of disease and injury.
The regulatory framework for ATMPs is established in Regulation (EC) No 1394/2007.
These pages provide information for applicants on:
- the classification of ATMP marketing-authorisation applications;
- certification of the quality of ATMPs;
- non-clinical data submitted by small and medium-sized enterprises (SMEs) developing ATMPs.
Support to companies
The Innovation Task Force (ITF) provides a forum for informal dialogue between the European Medicines Agency and companies or individuals in the early stages of the medicine development process.
In addition, the Agency can provide support to companies through:
- Regulation (EC) No 1394/2007
- European Commission: advanced therapies
- Committee for Advanced Therapies
- Medicines and emerging science
- Stem cells
- Council of Europe’s European Directorate for the Quality of Medicines and Healthcare (EDQM) and European Medicines Agency joint meeting on raw materials used for the production of cell-based and gene-therapy products (03/04/2013)
- Advanced-therapy medicinal products and the CAT (22/05/2013)