Abstract
The International Conference on Harmonization started in 1989. An overview has been given about milestones and history of the progress, focused on the safety topics.
Some reflections have been given about differences in approaches between the authorities involved and the legal bases that in some cases have also led to differences in scientific approaches. Harmonization of guidance content is much easier than harmonization of the systems.
Looking back on the ICH process after more than 20 years can teach us that by investing significant effort, an in-depth mutual understanding has been reached between the various regions and also between pharmaceutical industry and regulators.
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© 2013 American Association of Pharmaceutical Scientists
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van der Laan, J.W., DeGeorge, J.J. (2013). The International Conference on Harmonisation: History of Safety Guidelines. In: van der Laan, J., DeGeorge, J. (eds) Global Approach in Safety Testing. AAPS Advances in the Pharmaceutical Sciences Series, vol 5. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-5950-7_1
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DOI: https://doi.org/10.1007/978-1-4614-5950-7_1
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