Abstract
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.
The relevance and importance of the regulatory environment cannot be overemphasized.
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Further Readings
Cartwright AC, Matthews BR (Eds), 2009, International Pharmaceutical Product Registration. New York, NY: Informa Healthcare.
Mathieu M, 2008, New Drug Development: A Regulatory Overview, 8th Edition. Waltham, MA: Parexel.
Tobin JJ, Walsh G, 2008, Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, and Medical Devices. Weinheim, Germany: Wiley-VCH.
Weinberg S, 2009, Guidebook for Drug Regulatory Submissions. Hoboken, NJ: Wiley.
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Turner, J.R. (2010). The Regulatory Environment. In: New Drug Development. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-6418-2_2
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DOI: https://doi.org/10.1007/978-1-4419-6418-2_2
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