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Suggested Citation:"References." Institute of Medicine. 2013. International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18324.
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References

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IOM (Institute of Medicine). 2010. Transforming clinical research in the United States: Challenges and opportunities: Workshop summary. Washington, DC: The National Academies Press. IOM. 2011. Building a national framework for the establishment of regulatory science for drug development: Workshop summary. Washington, DC: The National Academies Press.

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IOM. 2012b. Envisioning a transformed clinical trials enterprise in the United States: Establishing an agenda for 2020: Workshop summary. Washington, DC: The National Academies Press. IOM. 2012c. Ensuring safe foods and medical products through stronger regulatory systems abroad. Washington, DC: The National Academies Press.

ISO (International Organization for Standardization). 2013. Standards: What is a standard? http://www.iso.org/iso/home/standards.htm (accessed April 19, 2013).

PANDRH (Pan American Network for Drug Regulatory Harmonization). 2000. 42nd Directing Council: Resolution CD42.R11: Drug Regulatory Harmonization. http://www1.paho.org/English/GOV/CD/cd42_r11-e.pdf (accessed April 19, 2013).

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Suggested Citation:"References." Institute of Medicine. 2013. International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18324.
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Trotta, F., H. G. Leufkens, J. H. Schellens, R. Laing, and G. Tafuri. 2011. Evaluation of oncology drugs at the European Medicines Agency and U.S. Food and Drug Administration: When differences have an impact on clinical practice. Journal of Clinical Oncology 29(16):2266–2272.

WHO (World Health Organization). 2010. The WTO agreements series: Sanitary and phytosanitary measures. Geneva, Switzerland: WHO Press. http://www.wto.org/english/res_e/booksp_e/agrmntseries4_sps_e.pdf (accessed April 19, 2013).

WHO. 2013. Norms and standards: Quality, safety and efficacy of medicines. http://www.who.int/medicines/areas/quality_safety/en (accessed April 22, 2013).

Suggested Citation:"References." Institute of Medicine. 2013. International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18324.
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Page 77
Suggested Citation:"References." Institute of Medicine. 2013. International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18324.
×
Page 78
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The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health.

To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.

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