ICH: Efficacy

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This page lists the scientific guidelines on efficacy 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).

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Table of contents

Clinical safety

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TopicDocumentsReference numberPublication dateEffective dateRemarks
E 1 Population exposure: The extent of population exposure to assess clinical safetyAdopted guidelineCPMP/ICH/375/95November 1994June 1995 
E 2 A Clinical safety data management: Definitions and standards for expedited reportingAdopted guidelineCPMP/ICH/377/95November 1994June 1995 
E 2 B (R3) Electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide

Adopted guideline
 

 

CHMP/ICH/287/1995July 2013July 2013See also: Questions and answers on the guideline
E 2 C (R1) Clinical safety data management: Periodic safety update reports for marketed drugsAdopted guidelineCPMP/ICH/288/95December 1996June 1997 
E 2 C (R2) Periodic benefit-risk evaluation report

Adopted guideline

Draft guideline

CHMP/ICH/544553/1998Dec 2012Jan 2013See also: Questions and answers on the guideline
E 2 D Post-approval safety data managementAdopted guidelineCPMP/ICH/3945/03November 2003May 2004 
E 2 E Pharmacovigilance Planning (Pvp)Adopted guidelineCPMP/ICH/5716/03Dec 2004Jun 2005 
E 2 F Development safety update reportAdopted guideline
Draft guideline
CHMP/ICH/309348/08September 2010September 2011 

Clinical study report

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TopicDocumentsReference numberPublication dateEffective dateRemarks
E 3 Structure and content of clinical study reportsAdopted guidelineCPMP/ICH/137/95December 1995July 1996 See also: Questions and answers on the guideline

Dose-response studies

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TopicDocumentsReference numberPublication dateEffective dateRemarks
E 4 Dose-response information to support drug registrationAdopted guidelineCPMP/ICH/378/95May 1994November 1994 

Ethnic factors

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TopicDocumentsReference numberPublication dateEffective dateRemarks
E 5 (R1) Ethnic factors in the acceptability of foreign clinical dataAdopted guidelineCPMP/ICH/289/95March 1998September 1998 
E 5 (R1) Questions and answers: Ethnic factors in the acceptability of foreign clinical dataAdopted guidelineCPMP/ICH/5746/03June 2006June 2006 

Good clinical practice

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TopicDocumentsReference numberPublication dateEffective dateRemarks
E 6 (R1) Guideline for good clinical practiceAdopted guidelineCPMP/ICH/135/95July 1996January 1997 
E 6 (R2) Guideline for good clinical practiceDraft guidelineCHMP/ICH/135/1995Released for consultation 4 August 2015 Deadline for comments 3 February 2016

Clinical trials

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TopicDocumentsReference numberPublication dateEffective dateRemarks
E 7 Studies in support of special populations: GeriatricsAdopted guidelineCPMP/ICH/379/95September 1993March 1994See also: Questions and answers on the guideline
E 8 General considerations for clinical trialsAdopted guidelineCPMP/ICH/291/95September 1997March 1998 
E 9 Statistical principles for clinical trialsAdopted guidelineCPMP/ICH/363/96March 1998September 1998 
E 10 Choice of control group in clinical trialsAdopted guidelineCPMP/ICH/364/96July 2000January 2001 
E 11 Clinical investigation of medicinal products in the paediatric populationAdopted guidelineCPMP/ICH/2711/99July 2000January 2001 

Guidelines for clinical evaluation by therapeutic category

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TopicDocumentsReference numberPublication dateEffective dateRemarks
E 12 Principles for clinical evaluation of new antihypertensive drugsAdopted guidelineCHMP/ICH/541/00June 2000June 2000 

Clinical evaluation

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TopicDocumentsReference numberPublication dateEffective dateRemarks
E 14 The clinical evaluation of QT/QTs interval prolongation and pro-arrhythmic potential for non-anti-arrhythmic drugsAdopted guidelineCHMP/ICH/2/04May 2005November 2005 See also questions and answers (updated Feb 2016)
E 15 Establish definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categoriesAdopted guidelineCHMP/ICH/437986/06November 2007May 2008 
E 16 Note for guidance on genomic biomarkers related to drug response: context, structure and format of qualification submissionsAdopted guideline
Draft guideline
EMEA/CHMP/ICH/380636/2009September 2010December 2010 
E 18 Guideline on genomic sampling and management of genomic dataDraft guidelineEMA/CHMP/ICH/11623/2016Released for consultation 1 Feb 2016 Deadline for comments 31 May 2016

 

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