Dossier Format: Regulatory and procedural guidance

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Table of contents

Application Dossier - CTD

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Document(s) Language Status First published Last updated Effective Date
ICH: M 4: Common technical document for the registration of pharmaceuticals for human use - Organisation of CTD - Step 5 (English only) adopted 01/02/2004   01/07/2003
ICH: M 4 Q: Common technical document for the registration of pharmaceuticals for human use - Quality - Step 5 (English only) adopted 01/07/2003   01/07/2003
ICH: M 4 S: Common technical document for the registration of pharmaceuticals for human use - Safety - Step 5 (English only) adopted 01/07/2003   01/07/2003
ICH: M 4 E: Common technical document for the registration of pharmaceuticals for human use - Efficacy - Step 5 (English only) adopted 01/07/2003   01/07/2003
ICH: M 4: Common technical document for the registration of pharmaceuticals for human use - Questions and answers - Step 5 (English only) adopted 01/06/2004   01/06/2004
ICH: M 4 Q: Location issues for common technical document for the registration of pharmaceuticals for human use - Quality questions and answers - Step 5 (English only) adopted 01/08/2003   01/08/2003
ICH: M 4 S: Common technical document for the registration of pharmaceuticals for human use - Safety questions and answers - Step 5 (English only) adopted 01/11/2003   01/11/2003
ICH: M 4 E: Common technical document for the registration of pharmaceuticals for human use - Efficacy questions and answers - Step 5 (English only) adopted 01/06/2004   01/06/2004

Application Dossier - eCTD

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Document(s) Language Status First published Last updated Effective Date
ICH: M 2: Electronic common technical document (e-CTD) - Step 5 (English only) adopted 01/05/2004 24/09/2010 01/05/2004

Electronic submissions to the European Medicines Agency

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Document(s) Language Status First published Last updated Effective Date
EMEA implementation of electronic-only submissions and eCTD submissions in the centralised procedure: Statement of intent (English only) adopted 22/01/2008    
EMEA implementation of electronic submissions and eCTD submissions: Statement of intent: Questions and answers relating to strategic and general aspects of the implementation (English only) adopted 22/01/2008    
EMEA implementation of electronic-only submission and eCTD submission: Questions and answers relating to practical and technical aspects of the implementation (English only) adopted 01/12/2008    
EMEA implementation of electronic-only submissions and mandatory eCTD submissions in the centralised procedure: Statement of intent (English only) adopted 01/12/2008    
EMEA implementation of electronic-only submissions and mandatory eCTD submissions in the centralised procedure: Statement of intent relating to non-eCTD submissions (English only) adopted 01/12/2008    
EMEA implementation of electronic-only submission and eCTD submission: Practical guidelines relating to non-eCTD electronic submissions (English only) adopted 01/12/2008