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The Interplay of Global Standards and EU Pharmaceutical Regulation

The International Council for Harmonisation

By: Sabrina Röttger-Wirtz
Media of The Interplay of Global Standards and EU Pharmaceutical Regulation
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Published: 26-08-2021
Format: EPUB eBook (?)
Edition: 1st
Extent: 256
ISBN: 9781509943005
Imprint: Hart Publishing
Series: Hart Studies in Law and Health
RRP: £76.50
Online price : £61.20
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About The Interplay of Global Standards and EU Pharmaceutical Regulation

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.

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