Based on author's thesis (doctoral)--Universiteit Maastricht, 2017. Includes bibliographical references (pages 220-236) and index.
Contents:
Introduction -- Regulating pharmaceuticals in the European Union : law and administrative rule-making -- EU risk regulation in a globalised world : global standards -- The International Council for Harmonisation : pharmaceutical standard-setting on the global level -- The implementation of ICH standards in the European Union -- Questioning the legitimacy of global standards -- Examining the legitimacy of the ICH standard-setting procedure and uploading EU administrative law -- Global pharmaceutical standards as a challenge for EU law : remedies within the EU -- Conclusion.
Summary:
"This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union"-- Provided by publisher.
This resource is supported by the Institute of Museum and Library Services under the provisions of the Library Services and Technology Act as administered by State Library of Iowa.