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Breaking up the band: European regulatory cooperation in a post-Brexit world

*

British Journal of Pharmacy

University of Huddersfield Press

Brexit, regulation, convergence, cooperation, EMA, MHRA

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      Abstract

      Since 1995, the European Medicines Agency (EMA) has progressed from harmonising regulation for human and veterinary medicines across the European Union Member State national competent authorities, to galvanising one of the most successful cooperative initiatives for regulation globally. Although the EMA is the focal point for stakeholders, regulation is delivered through the European medicines regulatory network, in which national authorities, like the UK’s Medicines & Healthcare products Regulatory Agency (MHRA), contribute. As with any collaboration, contributions by individual members vary, and the MHRA has been noted as an innovative and highly productive member of the network. Progress in regulation not only in Europe – but also around the world through convergence – can be attributed to this unique European cooperation. The decision by the UK to leave the European Union threatens to mark the end of this cooperation; we argue here that the best decision is to maintain regulatory cooperation under new structures.

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      Most cited references 1

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      Drug regulation: history, present and future

       Rägo,  Santoso,  van Boxtel (2008)
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        Author and article information

        Affiliations
        Research, Medical & Innovation, Association of the British Pharmaceutical Industry, Southside Building, Victoria Street, London, SW1E 6QT United Kingdom
        Author notes
        *Corresponding author. Tel.: +44 207 747 1408 E-mail: vacha@ 123456abpi.org.uk

        Conflicts of Interest

        The author is an Executive Director for Research, Medical & Innovation at the Association of the British Pharmaceutical Industry (London, UK), which is playing an important role in understanding the impact of leaving the EU on the UK’s world leading Life Sciences sector for the UK Government.

        Journal
        BJPharm
        British Journal of Pharmacy
        University of Huddersfield Press
        2058-8356
        01 August 2017
        : 2
        : 1
        : 70-74
        10.5920/bjpharm.2017.04
        © 2017, Virginia Acha

        This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY) 4.0 https://creativecommons.org/licenses/by/4.0/.

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