The Interplay of Global Standards and Eu Pharmaceutical Regulation

Name: The Interplay of Global Standards and Eu Pharmaceutical Regulation
Brand: Bloomsbury 3PL
Availability: OutOfStock
Rating: 5 (1 reviews)

By Sabrina Röttger-Wirtz

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Description

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.

Product details

Number of Pages:: 250
Release Date:: 2021-09-23
Publication Date:: 2021-09-23
Publisher:: Bloomsbury 3PL
Languages:: Original: English
ISBN10:: 1509942998
ISBN13:: 9781509942992
GPSR Manufacturer Reference:: [email protected]
Weight:: 543 g
Height:: 161 cm
Width:: 240 cm
Thickness:: 18 cm

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