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International Conference on Harmonisation - Joint Safety/Efficacy (Multidisciplinary)

Title and Format	Type	Issue Date
M2 eCTD: Electronic Common Technical Document Specification M2: eCTD Specification Questions and Answers and Change Requests Companion Document: Current Q & As and Change Requests	Final	4/1/2003 3/14/05 7/10/2008
M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals	Draft	9/3/2008
M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals	Final	11/1997
M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use M4: Organization of the CTD M4 Granularity Annex (Issued 10/18/2005, Posted 10/18/2005) M4: The CTD -- General Questions and Answers (Issued 12/04, Posted 12/22/2004) M4: The CTD -- Quality M4: The CTD -- Quality Questions and Answers /Location Issues (Issued 6/2004, Posted 6/8/2004) M4: The CTD -- Efficacy M4: The CTD -- Efficacy Questions and Answers (Issued 12/2004, Posted 12/22/2004) Clarification for Q&A 10 on submitting integrated summaries of safety and effectiveness (ISS/ISE) in the eCTD format [esrs/eCTD page]. M4: The CTD -- Safety M4: The CTD -- Safety Appendices M4: The CTD -- Safety Questions and Answers (Issued 2/2003, Posted 2/4/2003)	Final	Originally Issued 10/15/2001
M5 International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries	Draft	9/2005
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations	Draft	9/2001

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