Transcription of ICH HARMONISED GUIDELINE
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ICH HARMONISED GUIDELINE
INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL. REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH). ICH HARMONISED GUIDELINE . INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD clinical PRACTICE. E6(R2). Current Step 4 version dated 9 November 2016. E6(R1). Document History New First Codification History Date Codification November 2005. E6 Approval by the Steering Committee under Step 2 27 E6. and release for public consultation. April 1995. E6 Approval by the Steering Committee under Step 4 1 E6. and recommended for adoption to the three ICH May regulatory bodies.
1 INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE ICH E6(R2) INTRODUCTION Good Clinical Practice (GCP) is an international ethical and scientific quality standard for
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