M4_QAs (R3).docVIP

M4 Implementation Working Group Questions Answers (R3) Current version dated June 10, 2004  In order to facilitate the implementation of the CTD General (M4) guideline, the ICH Experts have developed a series of QAs: M4 QAs Document History First Codification History Date New CodificationNovember 2005 M4 QAs Approval by the Steering Committee. 12 September 2002 M4 QAs M4 QAs Approval by the Steering Committee of the newly added questions. 18 July 2003 M4 QAs (R1) M4 QAs Approval by the Steering Committee of the newly added questions. 11 November 2003 M4 QAs (R2) Current M4 Questions Answers posted on the web site M4 QAs Approval by the Steering Committee of the newly added questions. 10 June 2004 M4 QAs (R3) In November 2005, the ICH Steering Committee adopted a new codification system for ICH Guidelines.? The purpose of this new codification is to ensure that the numbering / coding of ICH Guidelines is more logical, consistent and clearer.? Because the new system applies to existing as well as new ICH Guidelines a history box has been added to the beginning of all Guidelines to explain how the Guideline was developed and what is the latest version. With the new codification revisions to an ICH Guideline are shown as (R1), (R2), (R3) depending on the number of revisions. Annexes or Addenda to Guidelines have now been incorporated into the core Guidelines and are indicated as revisions to the core Guideline (e.g., R1).  For better comprehension of the M4 references within the text, please see below the document change history for M4 guideline. M4 Document History First Codification History Date New CodificationNovember 2005 M4 Approval by the Steering Committee under Step 2 and release for public consultation. 20 July 2000 M4 M4 Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 8 November 2000 M4 M4 Approval by the Steering Committee of Numbering and Section Headers changes for consis