Medicamentos de terapia avanzada: clasificación, reglamentación y perspectivas.
Autor
Felipe Morales, KelseyFecha
2019Resumen
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.