Chapter 2. Development of Marketing Authorisation Procedures for Pharmaceuticals

  1. Nick Freemantle1 and
  2. Suzanne Hill2
  1. Alar Irs,
  2. Truus Janse de Hoog and
  3. Lembit Rägo

Published Online: 5 NOV 2007

DOI: 10.1002/9780470994719.ch2

Evaluating Pharmaceuticals for Health Policy and Reimbursement

Evaluating Pharmaceuticals for Health Policy and Reimbursement

How to Cite

Irs, A., de Hoog, T. J. and Rägo, L. (2004) Development of Marketing Authorisation Procedures for Pharmaceuticals, in Evaluating Pharmaceuticals for Health Policy and Reimbursement (eds N. Freemantle and S. Hill), Blackwell Science Ltd, Oxford, UK. doi: 10.1002/9780470994719.ch2

Editor Information

  1. 1

    Department of Primary Care and General Practice, University of Birmingham,Birmingham,UK

  2. 2

    Faculty of Health,University of Newcastle,Newcastle, Australia

Publication History

  1. Published Online: 5 NOV 2007
  2. Published Print: 1 AUG 2004

ISBN Information

Print ISBN: 9780727917843

Online ISBN: 9780470994719

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Keywords:

  • marketing authorisation system;
  • health policy;
  • new medicines;
  • european drug regulation;
  • clinical trials

Summary

This chapter contains sections titled:

  • Introduction

  • Development of the marketing authorisation system

  • Path to the current European Union marketing authorisation system

  • Centralised procedure

  • Mutual recognition procedure

  • Collaboration beyond the scope of the European Union

  • Failing trust, competition, and limited resources

  • Why are there two European procedures?

  • Major criticisms of the system: science or politics?

  • Perspective of legislation and subordination of the European Medicines Evaluation Agency

  • Secrecy and transparency

  • Race for the title of fastest drug regulatory agency

  • Is it getting better? Review 2001 and G10 Medicines Group

  • Limitations of the value of the clinical data used in licensing

  • Conclusion

  • References