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ICH Harmonization Eric W. Lewis, MD GlaxoSmithKline October 3 rd, 2002 The Basis of Global Drug Development.

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Presentation on theme: "ICH Harmonization Eric W. Lewis, MD GlaxoSmithKline October 3 rd, 2002 The Basis of Global Drug Development."— Presentation transcript:

1 ICH Harmonization Eric W. Lewis, MD GlaxoSmithKline October 3 rd, 2002 The Basis of Global Drug Development

2 ICH Harmonization - Globalization - The Present (Europe & US) FDA & EMEA readily accept data generated in the US/EU for use in registration –Most experience from US, Canada, & Europe –Little Asian experience Differences may exist in the Risk Benefit Assessment Differences may exist with respect to “Positioning” in the market

3 Important factors for acceptability of data are: –Design of trial –Conduct of the trial –Quality of the data Not important: –Location of trial ICH Harmonization - Globalization - The Present (FDA - Global Data)

4 (Japan – Global Data) Six drugs approved based upon “prospective” bridging –1 non-sedating antihistamine –2 migraine –1 influenza –2 cancer Four drugs approved or nearing approval but information lacking ICH Harmonization - Globalization - The Present

5 Let us bear in mind... –4/6 are “intermittent” therapy (Japan Global Data) –4/6 are not for chronic diseases like –Hypertension, Hyperlipidemia and other chronic diseases –CCDP included a considerable amount of Japanese data ICH Harmonization - Globalization - The Present

6 (FDA – “Asian” Data) New Indication for Kytril recently approved by FDA –PONV Japanese European Iressa (gefitinib) –NSCLC Pivotal US Study Global Supportive Study (  50% Japanese) ICH Harmonization - Globalization - The Present

7 Concluding Comments –Globalization of data occurring –Ethnicity is often more spiritual than physical –We are all individuals ICH Harmonization - Globalization - The Present


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