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European Medicines Agency July 2003. CPMP/ICH/2887/99 - Efficacy ICH Topic M 4 E. Common Technical Document for the Registration of Pharmaceuticals for Human Use Efficacy Step 5. Common Technical Document FOR THE REGISTRATION OF. PHARMACEUTICALS FOR HUMAN USE. clinical overview AND clinical SUMMARY OF MODULE 2. MODULE 5: STUDY REPORTS. (CPMP/ICH/2887/99 - Efficacy). TRANSMISSION TO CPMP July 2000. RELEASE FOR CONSULTATION July 2000. DEADLINE FOR COMMENTS September 2000. TRANSMISSION TO CPMP FOR INFORMATION November 2000. RELEASE FOR INFORMATION November 2000. NUMBERING AND SECTION HEADERS EDITED FOR September 2002. CONSISTENCY AND USE IN E-CTD AS AGREED BY ICH. STEERING COMMITTEE. TRANSMISSION TO CPMP AND RELEASE FOR INFORMATION February 2003. DATE FOR IMPLEMENTATION July 2003. Note: The sequence of M4 Common Technical Document for the Registration of Pharmaceuticals for Human Use is: M4 - Organisation of Common Technical Document M4 Quality - Quality overall summary of Module 2 and Module 3: Quality M4 Safety - Nonclinical overview and Nonclinical Summaries of Module 2 and Organisation of Module 4.
© emea 2006 3 common technical document for the registration of pharmaceuticals for human use: efficacy clinical overview and clinical summary of module 2
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