Transcription of E 11 Clinical Investigation of Medicinal Products in the ...
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E 11 Clinical Investigation of Medicinal Products in the ...
European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged January 2001 CPMP/ICH/2711/99 ICH Topic E 11 Clinical Investigation of Medicinal Products in the Paediatric Population Step 5 NOTE FOR GUIDANCE ON Clinical Investigation OF Medicinal Products IN THE PAEDIATRIC POPULATION (CPMP/ICH/2711/99) TRANSMISSION TO CPMP October 1999 RELEASE FOR CONSULTATION October 1999 DEADLINE FOR COMMENTS April 2000 FINAL APPROVAL BY CPMP July 2000 DATE FOR COMING INTO OPERATION January 2001 EMEA 2006 2 Clinical Investigation OF Medicinal Products IN THE PAEDIATRIC POPULATION 1.
E3: Structure and Content of Clinical Study Reports E4: Dose-Response Information to Support Drug Registration E5: Ethnic Factors in the Acceptability of Foreign Clinical Data E6: Good Clinical Practice: Consolidated Guideline E8: General Considerations for Clinical Trials E9: Statistical Principles for Clinical Trials
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