The Interplay of Global Standards and EU Pharmaceutical Regulation: The International Council for Harmonisation...

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Sabrina Röttger-Wirtz (Maastricht University, The Netherlands)

The Interplay of Global Standards and EU Pharmaceutical Regulation

The International Council for Harmonisation

Sabrina Röttger-Wirtz (Maastricht University, The Netherlands)

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English

Hart Publishing
23 March 2023

Medical & healthcare law

Series: Hart Studies in Law and Health

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.

By: Sabrina Röttger-Wirtz (Maastricht University The Netherlands)
Imprint: Hart Publishing
Country of Publication: United Kingdom
Dimensions: Height: 234mm, Width: 156mm, Spine: 25mm
Weight: 454g
ISBN: 9781509943081
ISBN 10: 1509943080
Series: Hart Studies in Law and Health
Pages: 256
Publication Date: 23 March 2023
Audience: College/higher education , Primary
Format: Paperback
Publisher's Status: Active

Sabrina Röttger-Wirtz is Assistant Professor of EU Law at Maastricht University, Netherlands.