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Q8, Q9, Q10 Questions and Answers

7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7040 E-mail Website An agency of the European Union European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged. December 2010 EMA/CHMP/ICH/265145/2009 Committee for medicinal products for human use (CHMP) ICH guideline Q8, Q9 and Q10 - Questions and Answers volume 4 Step 5 Transmission to CHMP for information December 2010 Release for information December 2010 ICH guideline Q8, Q9 and Q10 - Questions and Answers volume 4 EMA/CHMP/ICH/265145/2009 Page 2/17 ICH guideline Q8, Q9 and Q10 - Questions and Answers volume 4 Table of contents 1.

This Questions and Answers document (Q&A) refers to the current working procedure of the ICH Q- IWG on implementing the guidelines of Q8, Q9 and Q10 which have been approved by the ICH Steering Committee.

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