ICH: Multidisciplinary

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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 Council 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.

TopicDocumentsReference numberPublication dateEffective dateRemarks
M 2 Electronic common technical document (e-CTD) - File format criteriaAdopted guidelineCHMP/ICH/730231/2014January 2015  
M 2 Electronic common technical document (e-CTD)Adopted guidelineCPMP/ICH/1840/01September 2010 See also questions and answers on the guideline (updated January 2014)
M 2 Business requirementsAdopted guidelineCHMP/792476/09September 2010September 2010 
M 3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticalsAdopted guidelineCPMP/ICH/286/95June 2009December 2009 See also questions and answers on the guideline
M 4 Common technical document (CTD) for the registration of pharmaceuticals for human use - Organisation of CTDAdopted guidelineCPMP/ICH/2887/99November 2003February 2004 
M 4 Common technical document for the registration of pharmaceuticals for human use: Questions and answersAdopted guidelineCPMP/ICH/5552/02June 2004June 2004 
M 4 Q Common technical document for the registration of pharmaceuticals for human use - QualityAdopted guidelineCPMP/ICH/2887/02February 2003July 2003 
M 4 Q Location issues for common technical document for the registration of pharmaceuticals for human use - Quality: Questions and answersAdopted guidelineCPMP/ICH/4680/02July 2003August 2003 
M 4 E (R2) Common technical document for the 4 registration of pharmaceuticals for human use – EfficacyDraft guidelineCPMP/ICH/2887/1999Released for consultation October 2015 Deadline for comments 31 December 2015
M 4 E Common technical document for the registration of pharmaceuticals for human use - EfficacyAdopted guidelineCPMP/ICH/2887/99February 2003July 2003 
M 4 E Common technical document for the registration of pharmaceuticals for human use - Efficacy: Questions and answersAdopted guidelineCPMP/ICH/551/02June 2004June 2004 
M 4 S Common technical document for the registration of pharmaceuticals for human use - SafetyAdopted guidelineCPMP/ICH2887/99February 2003July 2003 
M 4 S Common technical document for the registration of pharmaceuticals for human use - Safety: Questions and answersAdopted guidelineCPMP/ICH/5549/02November 2003November 2003 
M 5 Data elements and standards for drug dictionariesDraft guidelineCHMP/ICH/168535/05May 2005 Deadline for comments September 2005
M 5 EWG Routes of administration controlled vocabularyAdopted guidelineCHMP/ICH/175860/05May 2005May 2005 
M 5 EWG Units and measurements controlled vocabularyAdopted guidelineCHMP/ICH/175818/05May 2005May 2005 
M 7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic riskAdopted guidelineEMA/CHMP/ICH/83812/2013September 2014January 2016 
M 7 Application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakesDraft guidelineEMA/CHMP/ICH/458894/2015Release for consultation 4 August 2015 Deadline for comments 3 February 2016
M 8 Electronic common technical document (e-CTD) v4.0 draft ICH implementation guide v2.0Draft guidelineEMA/CHMP/ICH/143002/2015May 2015 

Deadline for comments 22 May 2015

See also questions and answers on the guideline

 

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