7. Regulatory Authorities

  1. Rick Ng PhD, MBA

Published Online: 30 APR 2008

DOI: 10.1002/9780470403587.ch7

Drugs: From Discovery to Approval, Second Edition

Drugs: From Discovery to Approval, Second Edition

How to Cite

Ng, R. (2008) Regulatory Authorities, in Drugs: From Discovery to Approval, Second Edition, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470403587.ch7

Author Information

  1. A-Bio Pharma Pte Ltd, Singapore

Publication History

  1. Published Online: 30 APR 2008
  2. Published Print: 7 NOV 2008

ISBN Information

Print ISBN: 9780470195109

Online ISBN: 9780470403587



  • regulatory authorities role;
  • European medicines agency;
  • India and central drugs standard control organization (CDSCO)


This chapter contains sections titled:

  • Role of Regulatory Authorities

  • US Food and Drug Administration

  • European Medicines Agency

  • Japan's Ministry of Health, Labor and Welfare

  • China's State Food and Drug Administration

  • India's Central Drugs Standard Control Organization

  • Australia's Therapeutics Goods Administration

  • Canada's Health Canada

  • Other Regulatory Authorities

  • Authorities Other than Drug Regulatory Agencies

  • International Conference on Harmonization

  • World Health Organization

  • Pharmaceutical Inspection Cooperation Scheme

  • Case Study #7

  • Summary of Important Points

  • Review Questions

  • Brief Answers and Explanations

  • Further Reading