Medicamentos de terapia avanzada: clasificación, reglamentación y perspectivas.

Abstract

Advanced therapy drugs presume the beginning of new ways to solve certain pathologies which does not have effective treatments established properly. The development of these new medicines is based on the use of gene therapy, somatic cell and tissue or tissue engineering. It provides future perspectives regarding the regeneration of skin in burned people, cancer or muscular dystrophy. The authorization is carried out by the Committee for Advanced Therapies at the European Medicines Agency (EMA) which applies to the procedure the established guidelines in the legislative framework, whose journey goes back to the establishment of the same, for the first time in the European Regulation 1394/2007. Furthermore, apart from those already marketed there are six of these products which are in the process to be definitively authorized but are yet, in a stage of development, or approved but not extended equally. In the European Union, eight advanced therapy medicines have been found under the centralized marketing authorization. The current trend shunts in enhancing the application of these therapies so that the patient health is not compromised; such as the economic drug perspective of this field, being the fundamental innovation of the whole procedure.