Transcription of ETHNIC FACTORS IN THE A OF FOREIGN CLINICAL D E5(R1)
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ETHNIC FACTORS IN THE A OF FOREIGN CLINICAL D E5(R1)
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE ETHNIC FACTORS IN THE ACCEPTABILITY OF FOREIGN CLINICAL DATA E5(R1) Current Step 4 version dated 5 February 1998 (including the Post Step 4 corrections agreed by the Steering Committee on 11 March 1998) 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. E5(R1) Document History First Codification History Date New Codification November 2005 E5 Approval by the Steering Committee under Step 2 and release for public consultation.
strategies for accepting foreign clinical data as full or partial support for approval of an application in a new region. It is critical to appreciate that this guidance is not intended to alter the data requirements for registration in the new region; it seeks to recommend when these data requirements may be satisfied with foreign clinical data.
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