The Regulatory Environment



This chapter introduces the regulatory environment in which new drug development is conducted. This is largely a result of the work of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The ICH is an amalgamation of expertise from various agencies and organizations across the world.


Statistical Review Clinical Development Program Biological License Application Statistical Reviewer Japan Pharmaceutical Manufacturer Association 
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Further Readings

  1. Cartwright AC, Matthews BR (Eds), 2009, International Pharmaceutical Product Registration. New York, NY: Informa Healthcare.Google Scholar
  2. Mathieu M, 2008, New Drug Development: A Regulatory Overview, 8th Edition. Waltham, MA: Parexel.Google Scholar
  3. Tobin JJ, Walsh G, 2008, Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, and Medical Devices. Weinheim, Germany: Wiley-VCH.CrossRefGoogle Scholar
  4. Weinberg S, 2009, Guidebook for Drug Regulatory Submissions. Hoboken, NJ: Wiley.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  1. 1.Cardiac Safety Services QuintilesDurhamUSA

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