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ICH Harmonization

ICH Harmonization. The Basis of Global Drug Development. Eric W. Lewis, MD GlaxoSmithKline October 3 rd , 2002. ICH Harmonization - Globalization - The Present (Europe & US). FDA & EMEA readily accept data generated in the US/EU for use in registration

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ICH Harmonization

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

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

  4. ICH Harmonization - Globalization - The Present (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

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

  6. ICH Harmonization - Globalization - The Present (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)

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

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