Transcription of M4Q Implementation Working Group Questions & …
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M4Q Implementation Working Group Questions & …
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH Secretariat, c/o IFPMA,15, chemin Louis-Dunant, Box 195, 1211 Geneva 20, Switzerland Telephone: +41 (22) 338 32 06 Telefax: +41 (22) 338 32 30 E-mail : Web site : M4Q Implementation Working Group Questions & Answers (R1) Current version dated July 17, 2003 In order to facilitate the Implementation of the CTD Quality (M4Q) guideline, the ICH Experts have developed a series of Q&As: M4Q Q&As Document History First Codification History Date New Codification November 2005 M4Q Q&As Approval by the Steering Committee. 12 September 2002 M4Q Q&As Current M4Q Questions & Answers posted on the web site M4Q Q&As Approval by the Steering Committee of the newly added Questions .
1. Introduction This document is intended to provide additional guidance for the preparation of an application file in the CTD-Q format (see section 2: General Issues).
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