Description
Bloomsbury Publishing (UK) The Interplay of Global Standards and EU Pharmaceutical Regulation: The International Council for Harmonisation by Sabrina Roettger-Wirtz
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.