The European Medicines Agency (EMA) defines three kinds of Advanced Therapy Medicinal Products (ATMPs):
- Gene therapies: medicinal products containing recombinant nucleic acid as active substance thus to regulate, repair, replace, add or delete a genetic sequence or medicinal products whose therapeutic / prophylactic / diagnostic effect relates directly to the recombinant nucleic acid sequence or to its product of genetic expression.
- Somatic cell therapy medicinal products: cells substantially manipulated to acquire specific biological properties or cells/ tissues not intended to be used for the same essential functions in the body.
- Tissue engineered products: cells or tissues grown on 3D scaffold so they can be used to repair, regenerate or replace human tissue.
Although currently the number of marketed ATMPs is very limited, it is going to grow significantly in the next future, raising ethical, regulatory, organizational and funding issues.
MA Provider is highly involved in ATMPs consultancy projects. The aim of this section is to provide continuous update on the most relevant news regarding ATMPs.