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. 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.
The sequence of M4 Common Technical Document for the Registration of Pharmaceuticals for Human Use is: M4 - Organisation of Common Technical Document ... Details on how to prepare a submission dossier based on the CTD format including information on the content of Module I are included in the revision of the Notice to Applicants.
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