Clinical efficacy and safety: General

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This page lists the European Medicines Agency's scientific guidelines in the general field of clinical safety and efficacy.

If you have comments on a document which is open for consultation, please use the form for submission of comments on scientific guidelines.

TopicDocumentsReference numberPublication dateEffective dateRemarks
Points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populationsDraft guidelineEMA/CHMP/778709/2015Release for consultation 21 December 2015 End of consultation 31 May 2016
Scientific guidance on post-authorisation efficacy studiesDraft guidelineEMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015Release for consultation 6 November 2015 End of consultation 31 January 2016
Potential medication errors in the context of benefit risk balance and risk minimisation measures

Overview of comments

Adopted position paper

Draft position paper

EMA/CHMP/277591/2013June 2013June 2013 
Considerations given to designation of a single stereo isomeric form (enantiomer), a complex, a derivative, or a different salt or ester as new active substance in relation to the relevant reference active substance

Overview of comments

Reflection paper

Draft reflection paper

EMA/651649/2010November 2012October 2012 
Extrapolation of results from clinical studies conducted outside europe to the eu-population

Adopted guideline

Draft guideline

CHMP/EWP/692702/08November 2009May 2010 
Clinical evaluation of diagnostic agents - Appendix 1 to the guideline

Overview of comments

Adopted guideline

Draft guideline

CPMP/EWP/1119/98 Rev. 1August 2009February 2010 
Harmonisation and update of the clinical aspects in the authorised conditions of use for radiopharmaceuticals and other diagnostic medicinal productsConcept paperCHMP/EWP12052/08Release for consultation April 2008 End of consultation 31 July 2008
Specification limits for residues of metal catalysts

Adopted guideline

Draft guideline

Draft guideline

CPMP/SWP/QWP/4446/00February 2008September 2008 
Recommendation for revision of the points to consider on the evaluation of diagnostic agentsDraft guidelineCHMP/EWP/13062/07Release for consultation Feb 2007 End of consultation 31 May 2007
Development of a CHMP guideline on extrapolation results in clinical studies to the EU-populationConcept paperCHMP/EWP/7799/07Release for consultation Jan 2007 End of consultation 30 Apr 2007
The regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal productsReflection paperCPMP/EWP/139391/04July 2005January 2006 
Inclusion of appendices to clinical study reports in marketing authorisation applicationsAdopted guidelineCPMP/EWP/2998/03Jun 2004Dec 2004 
The evaluation of the diagnostic agentsPoints to considerCPMP/EWP/1119/98Nov 2001Jun 2002 
Co-ordinating investigator signature of clinical study reportsAdopted guidelineCPMP/EWP/2747/00Oct 2001Apr 2002 
Fixed combination medicinal products

Draft guideline

Draft concept paper

EMA/CHMP/281825/2015May 2015 End of consultation 15 November 2015
Fixed combination medicinal products

Overview of comments

Adopted guideline

Draft guideline

CHMP/EWP/240/95 Rev. 1Feb 2009Sep 2009 Under revision, see Concept paper
Clinical requirements for locally applied, locally acting products containing known constituentsAdopted guidelineCPMP/EWP/239/95Nov 1995Jun 1996 
Clinical investigation of chiral active substancesAdopted guideline3CC29AOct 1993  
ICH E1 population exposure: The extent of population exposure to assess clinical safetyAdopted guidelineCPMP/ICH/375/95Nov 1994Jun 1995 
ICH E2A clinical safety data management: Definitions and standards for expedited reportingAdopted guidelineCPMP/ICH/377/95Nov 1994Jun 1995 
ICH E2F development safety update report

Adopted guideline

Draft guideline

CHMP/ICH/309348/08Sep 2010Sep 2011 
ICH E3 structure and content of clinical study reports
- Questions and answers
Adopted guidelineCPMP/ICH/137/95Dec 1995Jul 1996 
ICH E4 dose response information to support drug registrationAdopted guidelineCPMP/ICH/378/95May 1994Nov 1994 
ICH E5 (R1) ethnic factors in the acceptability of foreign clinical dataAdopted guidelineCPMP/ICH/289/95Mar 1998Sep 1998 
ICH E5 (R1) questions and answers ethnic factors in the acceptability of foreign clinical dataAdopted guidelineCPMP/ICH/5746/03Nov 2003  
ICH E6 (R1) guideline for good clinical practiceAdopted guidelineCPMP/ICH/135/95Jul 1996Jan 1997 
ICH E7 studies in support of special populations: Geriatrics
- Questions and answers
Adopted guidelineCPMP/ICH/378/05Sep 1993Mar 1994 
ICH E8 general considerations for clinical trialsAdopted guidelineCPMP/ICH/291/95Sep 1993Mar 1994 
ICH E11 clinical investigation of medicinal products in the paediatric populationAdopted guidelineCPMP/ICH/2711/99Jul 2000Jan 2001 

 

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