Transcription of GUIDELINE FOR GOOD CLINICAL PRACTICE
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GUIDELINE FOR GOOD CLINICAL PRACTICE
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE SAFETY PHARMACOLOGY STUDIES FOR HUMAN PHARMACEUTICALS S7A Current Step 4 version dated 8 November 2000 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. S7A Document History First Codification History Date New Codification November 2005 S7A Approval by the Steering Committee under Step 2 and release for public consultation.
Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (M3)” and “Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (S6)” as studies that should be conducted to support use of therapeutics in humans (1, 2).
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