RT info:eu-repo/semantics/bachelorThesis
T1 Productos sanitarios en combinación: regulación y aspectos técnicos
A1 Lopez Meier, Paula
A2 Grado En Farmacia
K1 Productos combinados
K1 Producto sanitario
K1 Marco legal
K1 Reglamento (EU) 2017/745
K1 Productos a medida
AB Drug - device combination products improve therapeutic adherence, which iscrucial in achieving positive outcomes. The resulting increase in its use in recentyears has promoted the revision of its regulation, thus giving rise to Regulation(EU) 2017/745, on medical devices. The aim of this project was to break downthe regulation, the classification and the relevant aspects regarding to drug –device combination products. For that purpose, a bibliographic review was carriedout through PubMed and government web pages, selecting the articles based onthe year of publication and the degree of adjustment to the proposed objectives.Regulation (EU) 2017/745 clarifies the definition and classification of combinationproducts according to their principal mode of action. In addition, it assigns to theEuropean Medicines Agency the marketing authorization of combined products,and includes for the first time the concept of custom-made devices.Finally, although the new regulation raises most of the aspects of interest in termsof combination products, recent progress in personalized medicine boosts theneed to establish future regulations and cooperation between different sectors.
YR 2023
FD 2023
LK http://riull.ull.es/xmlui/handle/915/33751
UL http://riull.ull.es/xmlui/handle/915/33751
LA es
DS Repositorio institucional de la Universidad de La Laguna
RD 12-may-2024