Chapter 19. Technical Requirements for Registration of Pharmaceuticals for Human Use: the ICH Process

  1. John P Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM1,
  2. John O'Grady MD, FRCP, FFPM, FBIRA, MRCPath2
  1. Dean WG Harron

Published Online: 25 OCT 2007

DOI: 10.1002/9780470987391.ch19

Book Title

The Textbook of Pharmaceutical Medicine, Fifth Edition

The Textbook of Pharmaceutical Medicine, Fifth Edition

Additional Information

How to Cite

Harron, D. W. (2007) Technical Requirements for Registration of Pharmaceuticals for Human Use: the ICH Process, in The Textbook of Pharmaceutical Medicine, Fifth Edition (eds J. P. Griffin and J. O'Grady), Blackwell Publishing Ltd, Oxford, UK. doi: 10.1002/9780470987391.ch19

Editor Information

  1. 1

    Director, Asklepieion Consultancy Ltd., Visiting Professor, University of Surrey Postgraduate Medical School, Former Director, Association of the British Pharmaceutical Industry, London, Formerly Professional Head of the Medicines Division, DHSS, London

  2. 2

    Visiting Professor of Clinical Pharmacology, University of London

Publication History

  1. Published Online: 25 OCT 2007
  2. Published Print: 15 DEC 2005

ISBN Information

Print ISBN: 9780727918406

Online ISBN: 9780470987391

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CHAPTER TOOLS

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Keywords:

  • product registration;
  • international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH);
  • new medicines;
  • ICH steering committee;
  • common technical document

Summary

This chapter contains sections titled:

  • Introduction

  • ICH Organisation

  • The ICH Process

  • ICH 5 Meeting Report

  • The CTD Post-ICH 5

  • ICH6: November 2003 Osaka

  • Developments: Washington, June 2004

  • Developments: Yokohama November 2004

  • Conclusion to date

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