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 Conference 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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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| E 1 Population exposure: The extent of population exposure to assess clinical safety | Adopted guideline | CPMP/ICH/375/95 | November 1994 | June 1995 | |
| E 2 A Clinical safety data management: Definitions and standards for expedited reporting | Adopted guideline | CPMP/ICH/377/95 | November 1994 | June 1995 | |
| E 2 B (M) Note for guidance on clinical safety data management: Data elements for transmission of individual case safety reports | Adopted guideline | CPMP/ICH/287/95 | November 2000 | November 2000 | |
| E 2 B (R3) Data elements for transmission of individual case safety reports | Draft guideline
Appendix Reference Instance Schema | CHMP/ICH/166783/05 | October 2011 | | Deadline for comments March 2012 |
| E 2 B (R5) Questions and answers: Data elements for transmission of individual case safety reports | Adopted guideline | CHMP/ICH/3943/03 | March 2005 | January 2005 | |
| E 2 C (R1) Clinical safety data management: Periodic safety update reports for marketed drugs | Adopted guideline | CPMP/ICH/288/95 | December 1996 | June 1997 | |
| E 2 C (R2) Periodic benefit-risk evaluation report | Draft guideline | EMA/CHMP/ICH/544553/1998 | April 2012 | | Deadline for comments May 2012 |
| E 2 D Post-approval safety data management | Adopted guideline | CPMP/ICH/3945/03 | November 2003 | May 2004 | |
| E 2 E Pharmacovigilance Planning (Pvp) | Adopted guideline | CPMP/ICH/5716/03 | Dec 2004 | Jun 2005 | |
| E 2 F Development safety update report | Adopted guideline
Draft guideline | CHMP/ICH/309348/08 | September 2010 | September 2011 | |
Clinical study report
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| E 3 Structure and content of clinical study reports | Adopted guideline | CPMP/ICH/137/95 | December 1995 | July 1996 | |
Dose-response studies
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| E 4 Dose-response information to support drug registration | Adopted guideline | CPMP/ICH/378/95 | May 1994 | November 1994 | |
Ethnic factors
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| E 5 (R1) Ethnic factors in the acceptability of foreign clinical data | Adopted guideline | CPMP/ICH/289/95 | March 1998 | September 1998 | |
| E 5 (R1) Questions and answers: Ethnic factors in the acceptability of foreign clinical data | Adopted guideline | CPMP/ICH/5746/03 | June 2006 | June 2006 | |
Good clinical practice
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| E 6 (R1) Guideline for good clinical practice | Adopted guideline | CPMP/ICH/135/95 | July 1996 | January 1997 | |
Clinical trials
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| E 7 Studies in support of special populations: Geriatrics | Adopted guideline | CPMP/ICH/379/95 | September 1993 | March 1994 | See also: Questions and answers on the guideline |
| E 8 General considerations for clinical trials | Adopted guideline | CPMP/ICH/291/95 | September 1997 | March 1998 | |
| E 9 Statistical principles for clinical trials | Adopted guideline | CPMP/ICH/363/96 | March 1998 | September 1998 | |
| E 10 Choice of control group in clinical trials | Adopted guideline | CPMP/ICH/364/96 | July 2000 | January 2001 | |
| E 11 Clinical investigation of medicinal products in the paediatric population | Adopted guideline | CPMP/ICH/2711/99 | July 2000 | January 2001 | |
Guidelines for clinical evaluation by therapeutic category
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| E 12 Principles for clinical evaluation of new antihypertensive drugs | Adopted guideline | CHMP/ICH/541/00 | June 2000 | June 2000 | |
Clinical evaluation
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| Topic | Documents | Reference number | Publication date | Effective date | Remarks |
|---|
| E 14 The clinical evaluation of QT/QTs interval prolongation and pro-arrhythmic potential for non-anti-arrhythmic drugs | Adopted guideline | CHMP/ICH/2/04 | May 2005 | November 2005 | |
| E 14 Questions and answers: The clinical evaluation of QT/QTs interval prolongation and pro-arrhythmic potential for non-anti-arrhythmic drugs | Adopted guideline | CHMP/ICH/310133/08 | June 2008 | June 2008 | |
| E 15 Establish definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories | Adopted guideline | CHMP/ICH/437986/06 | November 2007 | May 2008 | |
| E 16 Note for guidance on genomic biomarkers related to drug response: context, structure and format of qualification submissions | Adopted guideline
Draft guideline | EMEA/CHMP/ICH/380636/2009 | September 2010 | December 2010 | |
