alexa Development of Innovative Medicines for European Patients and Impact of Brexit | OMICS International | Abstract
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Case Report

Development of Innovative Medicines for European Patients and Impact of Brexit

Enzmann H* and Norta M

Federal Institute for Drugs and Medical Devices

Corresponding Author:
Enzmann H
Federal Institute for Drugs and Medical Devices,
Bundesinstitut für Arzneimittel und Medizinprodukte,
Kurt Georg Kiesinger Allee 3, 53175 Bonn, Germany
Tel: 492282073315
Fax: + 49 228 207 3535
E-mail: [email protected]

Received Date: July 30, 2016; Accepted Date: August 10, 2016; Published Date: August 12, 2016

Citation: Enzmann H, Norta M (2016) Development of Innovative Medicines for European Patients and Impact of Brexit. Pharmaceut Reg Affairs 5:171. doi: 10.4172/2167-7689.1000171

Copyright: © 2016 Enzmann H et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

European patients may benefit from innovative medicines only at the end of a complex process with a sequence of positive decisions on different levels by different stakeholders. The decision of the industry to invest in a usually global clinical development must be followed by a European marketing authorization decision and a mostly national decision on price and reimbursement until finally patients and their physicians can make an individual treatment decision. Development strategies must consider the evolution of scientific and procedural requirements. Current trends are characterized by an enhanced cooperation of regulators and health technology assessment-bodies. The increasing availability of innovative personalized or precision medicines is reflected in the new procedural tools like European Medicines Agency’s priority medicines scheme and adaptive pathways concept. The UK decision to leave the EU will have consequences for their contribution to the European regulatory and health technology assessment network. Current strategies for the successful development of innovative medicines may need adjustments to address both scientific and political changes.

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