Transcription of ICH HARMONISED TRIPARTITE GUIDELINE
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ICH HARMONISED TRIPARTITE GUIDELINE
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE EVALUATION AND RECOMMENDATION OF pharmacopoeial TEXTS FOR USE IN THE ICH REGIONS Q4B Current Step 4 version dated 1 November 2007 This GUIDELINE has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. Q4B Document History Code * History Date Q4B Approval by the Steering Committee under Step 2 and release for public consultation. 8 June 2006 Current Step 4 version Q4B Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.
pharmacopoeial text that has been submitted to the Q4B evaluation process. Any change to pharmacopoeial text that has been proposed to, or recommended through, the Q4B evaluation process will prompt a Q4B EWG review to assess both the merit of the change and the appropriateness of any subsequent Q4B activity related to that text. 2. GUIDELINES
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