The Interplay of Global Standards and EU Pharmaceutical Regulation: The International Council for Harmonisation 9781509942992

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Автор: Sabrina Rottger-Wirtz
Название: The Interplay of Global Standards and EU Pharmaceutical Regulation: The International Council for Harmonisation
ISBN: 9781509942992
Издательство: Bloomsbury Academic
Классификация:

Медицинское право и законодательство о медицинском обслуживании

ISBN-10: 1509942998
Обложка/Формат: Hardback
Страницы: 256
Вес: 0.30 кг.
Дата издания: 23.09.2021
Серия: Hart studies in law and health
Язык: English
Размер: 234 x 156 x 25
Читательская аудитория: Tertiary education (us: college)
Ключевые слова: Medical & healthcare law, LAW / Medical Law & Legislation
Подзаголовок: The international council for harmonisation
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Поставляется из: Англии
Описание: 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.

The Interplay of Global Standards and EU Pharmaceutical Regulation: The International Council for Harmonisation, Sabrina Rottger-Wirtz