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Regulatory Guidance: ICH, EMA, FDA

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Drug Discovery and Evaluation: Methods in Clinical Pharmacology

Abstract

Two revolutionary breakthroughs have favored the international development of pharmaceutical compounds: on one hand the International Conferences on Harmonization (ICH), on the other hand the computer sciences. ICH provides tremendous support for the strategies in general by creating global guidelines, and these recommend the basis for research, for preclinical and clinical development. A great number of solutions for detailed pending issues in the areas of Quality, Safety and Efficacy are offered. The enormous amount of data is then organized for the Common Technical Dossier by teams of experimental researchers, physicians, computer scientists and statisticians for submission to Regulatory Agencies for the final evaluations necessary before the market authorization. Thus, the pharmaceutical field is passing through a major period of transformation. Many changes are driven by information technology, but also by enormous progress in medical scientific research. Therefore, it has to be recognized that many breakthroughs, made in labs as well as on laptops, have changed and facilitated the pharmaceutical world.

This chapter highlights the progress in the International Conferences on Harmonization during the last decades; the focus is on preclinical Safety (Pharmacology and Regulatory Toxicology) with the objectives to identify risks for drugs in development by in sillico, in vitro and in vivo methods to prevent, treat and cure diseases. When needed, then also regional guidances, e.g. from US Food and Drug Administration (FDA) or European Medicines Agency (EMA) are referred to. This global, complex procedure reveals: we are now living in the age of big data and success is only possible by an enthusiastic multidisciplinary communication and transparent cooperation.

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Authors and Affiliations

  1. Institute for Pharmacology and Toxicology, University Medical Center, University of Goettingen, Goettingen, Germany

    Gerd Bode

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  1. Gerd Bode
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Correspondence to Gerd Bode .

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Editors and Affiliations

  1. CorDynamics , Dieburg, Germany

    Franz J. Hock

  2. CorDynamics , Chicago, IL, USA

    Michael R. Gralinski

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Bode, G. (2018). Regulatory Guidance: ICH, EMA, FDA. In: Hock, F., Gralinski, M. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Cham. https://doi.org/10.1007/978-3-319-56637-5_58-1

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  • DOI: https://doi.org/10.1007/978-3-319-56637-5_58-1

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  • Print ISBN: 978-3-319-56637-5

  • Online ISBN: 978-3-319-56637-5

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