290
views
0
recommends
+1 Recommend
1 collections
    8
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

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

      research-article
      *
      British Journal of Pharmacy
      University of Huddersfield Press
      Brexit, regulation, convergence, cooperation, EMA, MHRA

      Read this article at

      ScienceOpenPublisher
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          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.

          Most cited references1

          • Record: found
          • Abstract: not found
          • Article: not found

          Drug regulation: History, present and future.

            Bookmark

            Author and article information

            Journal
            BJPharm
            British Journal of Pharmacy
            University of Huddersfield Press
            2058-8356
            01 August 2017
            : 2
            : 1
            : 70-74
            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.

            Article
            10.5920/bjpharm.2017.04
            162df6cd-0de0-4146-8237-d71061ff7f47
            © 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/.

            History
            : 21 July 2017
            : 24 July 2017
            : 28 July 2017
            Categories
            Expert Opinion

            Medicine,Pharmacology & Pharmaceutical medicine,Health & Social care
            Brexit,cooperation,EMA,MHRA,regulation,convergence

            Comments

            Comment on this article