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Q8 (R2) Step 5 Pharmaceutical Development

30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 22 June 2017 EMA/CHMP/ICH/167068/2004 Committee for Human Medicinal Products ICH guideline Q8 (R2) on Pharmaceutical Development Step 5 Transmission to CHMP December 2004 Transmission to interested parties December 2004 Deadline for comments June 2005 Final adoption by CHMP November 2005 Date for coming into effect May 2006 Editorial corrections August 2009 Link to: ICH Q8/Q9/Q10 Training material Link to: ICH Q8/Q9/Q10 Points to consider ICH g

ICH guideline Q8 (R2) on pharmaceutical development EMA/CHMP/ICH/167068/2004 Page 5/24 Part I: Pharmaceutical Development 1. Introduction

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