Chapter 11. Drug Approval in the European Union and the United States

  1. Dr. Oliver Kayser,
  2. Prof. Dr. Rainer H. Müller
  1. Dr. Gary Walsh

Published Online: 28 JAN 2005

DOI: 10.1002/3527602410.ch11

Book Title

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications

Additional Information

How to Cite

Walsh, G. (2005) Drug Approval in the European Union and the United States, in Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications (eds O. Kayser and R. H. Müller), Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, FRG. doi: 10.1002/3527602410.ch11

Editor Information

  1. Free University Berlin, Institute of Pharmacy, Pharmaceutical Technology, Biopharmacy & Biotechnology, Kelchstr. 31, 12169 Berlin, Germany

Author Information

  1. Industrial Biochemistry Program, University of Limerick, Limerick City, Ireland

Publication History

  1. Published Online: 28 JAN 2005
  2. Published Print: 28 JAN 2004

ISBN Information

Print ISBN: 9783527305544

Online ISBN: 9783527602414

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Keywords:

  • pharmaceutical biotechnology;
  • drug approval in the European Union;
  • drug approval in the United States;
  • EMEA;
  • CDER;
  • CBER

Summary

  • Introduction

  • Regulation within the European Union

    • The EU Regulatory Framework

    • The EMEA

    • New Drug Approval Routes

      • The Centralized Procedure

      • Mutual Recognition

  • Regulation in the United States

    • CDER and CBER

    • The Approvals Procedure

  • International Regulatory Harmonization

  • References

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