27. Regulatory Issues (FDA and EMA)

  1. W. John W. Morrow PhD, DSc, FRCPath3,
  2. Nadeem A. Sheikh PhD4,
  3. Clint S. Schmidt PhD5 and
  4. D. Huw Davies PhD6
  1. Murrium Ahmad PhD1,
  2. Victoria Byers2 and
  3. Peter Wilson PhD, MBA, LLB2

Published Online: 20 JUN 2012

DOI: 10.1002/9781118345313.ch27

Vaccinology: Principles and Practice

Vaccinology: Principles and Practice

How to Cite

Ahmad, M., Byers, V. and Wilson, P. (2012) Regulatory Issues (FDA and EMA), in Vaccinology: Principles and Practice (eds W. J. W. Morrow, N. A. Sheikh, C. S. Schmidt and D. H. Davies), Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781118345313.ch27

Editor Information

  1. 3

    Seattle, WA, USA

  2. 4

    Dendreon Corporation, Seattle, WA, USA

  3. 5

    NovaDigm Therapeutics, Inc., Grand Forks, ND, USA

  4. 6

    University of California at Irvine, Irvine, CA, USA

Author Information

  1. 1

    The John van Geest Cancer Research Centre, School of Science and Technology, Nottingham Trent University, Nottingham, UK

  2. 2

    NJM European Economic & Management Consultants Ltd, Gosforth, Newcastle Upon Tyne, UK

Publication History

  1. Published Online: 20 JUN 2012
  2. Published Print: 3 AUG 2012

ISBN Information

Print ISBN: 9781405185745

Online ISBN: 9781118345313



  • EMEA;
  • FDA;
  • vaccines;
  • Herceptin®;
  • Cervarix®


The eradication of diseases such as small pox and reduced threat of infections such as polio have been possible thanks to advances in medical sciences and widespread vaccinations. However, it would be very naïve and complacent for us to think that there will not be another disease such as AIDS or SARS sooner or later.

Preparing populations for health threats from either new or re-emerging infectious diseases is recognized as an important public health priority.

Vaccines offer a cost-effective means to prevent disease, including cancer. However, there are regulatory issues associated with each vaccine that is developed and the aim of this chapter is to discuss the regulatory issues faced by vaccines from both the FDA and EMEA.