Despite tremendous progress in science and increasing investment in research and development, patients' access to innovative medicines remains limited. This is in part due to increasing regulatory requirements for product authorisation and cost-constrained national health systems. At the European Medicines Agency (EMA), we have tried to address these constraints by adapting our organisation and activities to changing business models, new technologies, and the current and emerging health needs in Europe. The main EMA initiatives to provide patients with effective, safe and affordable medicines are reviewed.
Rasi, G., Bonini, S. (2015). Innovative medicines: New regulatory procedures for the third millennium. EXPERT OPINION ON BIOLOGICAL THERAPY, 15(sup1), 5-8 [10.1517/14712598.2015.1026322].
Innovative medicines: New regulatory procedures for the third millennium
Rasi G.Membro del Collaboration Group
;Bonini S.Membro del Collaboration Group
2015-01-01
Abstract
Despite tremendous progress in science and increasing investment in research and development, patients' access to innovative medicines remains limited. This is in part due to increasing regulatory requirements for product authorisation and cost-constrained national health systems. At the European Medicines Agency (EMA), we have tried to address these constraints by adapting our organisation and activities to changing business models, new technologies, and the current and emerging health needs in Europe. The main EMA initiatives to provide patients with effective, safe and affordable medicines are reviewed.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
