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This page lists the multidisciplinary scientific guidelines published by the European Medicines Agency following agreement on a harmonised approach between Europe, Japan and the United States of America by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
If you have comments on a document that is open for consultation, use the form for submission of comments on scientific guidelines.
| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|---|---|---|---|---|
| M 2 Electronic common technical document (e-CTD) | Adopted guideline | CPMP/ICH/1840/01 | September 2010 | See also questions and answers | |
| M 2 Business requirements | Adopted guideline | CHMP/792476/09 | September 2010 | September 2010 | |
| M 3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals | Adopted guideline | CPMP/ICH/286/95 | June 2009 | December 2009 | See also questions and answers |
| M 4 Common technical document (CTD) for the registration of pharmaceuticals for human use - Organisation of CTD | Adopted guideline | CPMP/ICH/2887/99 | November 2003 | February 2004 | |
| M 4 Common technical document for the registration of pharmaceuticals for human use: Questions and answers | Adopted guideline | CPMP/ICH/5552/02 | June 2004 | June 2004 | |
| M 4 Q Common technical document for the registration of pharmaceuticals for human use - Quality | Adopted guideline | CPMP/ICH/2887/02 | February 2003 | July 2003 | |
| M 4 Q Location issues for common technical document for the registration of pharmaceuticals for human use - Quality: Questions and answers | Adopted guideline | CPMP/ICH/4680/02 | July 2003 | August 2003 | |
| M 4 E Common technical document for the registration of pharmaceuticals for human use - Efficacy | Adopted guideline | CPMP/ICH/2887/99 | February 2003 | July 2003 | |
| M 4 E Common technical document for the registration of pharmaceuticals for human use - Efficacy: Questions and answers | Adopted guideline | CPMP/ICH/551/02 | June 2004 | June 2004 | |
| M 4 S Common technical document for the registration of pharmaceuticals for human use - Safety | Adopted guideline | CPMP/ICH2887/99 | February 2003 | July 2003 | |
| M 4 S Common technical document for the registration of pharmaceuticals for human use - Safety: Questions and answers | Adopted guideline | CPMP/ICH/5549/02 | November 2003 | November 2003 | |
| M 5 Data elements and standards for drug dictionaries | Draft guideline | CHMP/ICH/168535/05 | May 2005 | Deadline for comments September 2005 | |
| M 5 EWG Routes of administration controlled vocabulary | Adopted guideline | CHMP/ICH/175860/05 | May 2005 | May 2005 | |
| M 5 EWG Units and measurements controlled vocabulary | Adopted guideline | CHMP/ICH/175818/05 | May 2005 | May 2005 |
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