Transcription of M 4 S Common Technical Document for the Registration …
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M 4 S Common Technical Document for the Registration …
European Medicines Agency July 2003. CPMP/ICH/2887/99 - Safety ICH Topic M 4 S. Common Technical Document for the Registration of Pharmaceuticals for Human Use - Safety Step 5. Common Technical Document FOR THE Registration OF. PHARMACEUTICALS FOR HUMAN USE. NONCLINICAL OVERVIEW AND NONCLINICAL SUMMARIES. OF MODULE 2. ORGANISATION OF MODULE 4. (CPMP/ICH/2887/99 - Safety). 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.
the Common Technical Document. In general, the Nonclinical Overview should not exceed about 30 pages. General Aspects The Nonclinical Overview should present an integrated and critical assessment of the pharmacologic, pharmacokinetic, and toxicologic evaluation of the pharmaceutical. Where
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