Médicaments de thérapie innovante : réglementation et applications cliniques

Abstract

The European regulation introduced in 2007 a new class of biological products, named “Advanced Therapy Medicinal Products” (ATMPs) in order to clarify and harmonize the authorization rules of these products in Europe as well as to facilitate their availability for the patients. ATMPs include somatic cell therapy and gene therapy medicinal products, products derived from cellular and tissue engineering, possibly combined with medical devices. The classification of tissue or cell-based therapeutic approaches as medicinal products introduces specific legislation concerning their development and clinical trials, manufacture and marketing authorization. Most of the ATMPs come from the progress made in recent years in biotechnology and also in the knowledge of stem cell biology. The clinical applications are numerous, mainly in hematology and oncology, but also in the field of regenerative medicine.