European Pharmaceutical Product Registration

European Pharmaceutical Product Registration : Requirements for Europe

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This is a reference text for all pharmaceutical companies, and related consultancy and contract companies worldwide who have an interest in exploiting the largest single market in the world - the European Union. Changes in EU regulations have occurred in the 1990s that have created both challenges and opportunities for the pharmaceutical industry. This book provides a clear overview for all those involved in registering new pharmaceutical products in the EU. It covers subjects such as: new European institutions (EMEA and CPMP) and how they operate; detailed accounts of the functions of the national agencies in all 15 EU member states; in-depth accounts of the key technical requirements for New Active Substance (NAS) products utilizing the "Pharmaceutical Evaluation Report Scheme". The book also covers all aspects of quality, safety, efficacy and environmental risk regulation, making it of relevance to all those in the pharmaceutical industry, as well as biologists, chemists, pharmacists, quality assurance staff, analytical chemists, clinicians and CRAs involved in the development of new pharmaceutical products.
Anyone involved in the marketing of a new drug in the EU should find this book of value.
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Product details

  • Hardback | 512 pages
  • Taylor & Francis Ltd
  • London, United Kingdom
  • 074840581X
  • 9780748405817