Clinical efficacy and safety: Anti-infectives for systemic use

  • Email
  • Help

This page lists the European Medicines Agency's scientific guidelines on the clinical safety and efficacy of medicines used to treat or prevent infections. 

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

Please note that the Efficacy Working Party secretariat e-mail address (ewpsecretariat@ema.europa.eu) no longer exists. Therefore, please submit your comments from now on to the following e-mail address: idwpsecretariat@ema.europa.eu.

TopicDocumentsReference numberPublication dateEffective dateRemarks
The use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal productsDraft guideline
Draft concept paper
Adopted guideline
EMA/CHMP/594085/2015Released for consultation September 2015 Deadline for comments 31 March 2016
Clinical development of medicinal products for treatment of HIV infectionDraft guidelineCPMP/EWP/633/2002 Rev. 3Released for consultation Sep 2013 Deadline for comments 31 March 2014
Clinical development of medicinal products for treatment of HIV infection

Overview of comments

Adopted guideline

Draft guideline

Concept paper

Concept paper - Annex A

Concept paper - Annex B

CPMP/EWP/633/2002 Rev. 2November 2008June 2009 
Update of guidance on the clinical development of medicinal products for the treatment of HIVConcept paperEMA/802793/2011Released for consultation October 2011 Deadline for comments 31 January 2012
Non-clinical and clinical development for oral and topical HIV pre-exposure prophylaxis (PrEP)

Reflection paper

Concept paper

EMA/171264/2012Released for consultation March 2012 Deadline for comments 30 June 2012
Clinical evaluation of medicinal products for the treatment of chronic hepatitis CDraft guidelineEMA/CHMP/51240/2011Released for consultation January 2011 Deadline for comments 31 August 2011
Need for revision of the guideline on the clinical development of medicinal products for the treatment of hepatitis CConcept paperEMA/CHMP/EWP/825749/2009Released for consultation April 2010 Deadline for comments 31 July 2010
Clinical evaluation of direct acting antiviral agents intended for treatment of chronic hepatitis C

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/EWP/30039/2008May 2009November 2009 
Clinical evaluation of antifungal agents for the treatment and prophylaxis invasive fungal disease

Overview of comments

Adopted guideline

Draft guideline

Points to consider

CPMP/EWP/1343/2001 Rev. 1April 2010November 2010 
Clinical investigation of medicinal products for the treatment of sepsisAdopted guidelineCPMP/EWP/4713/2003June 2006November 2006 
Clinical evaluation of medicinal products intended for treatment of hepatitis BAdopted guidelineCPMP/EWP/6172/2003February 2006September 2006 
Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2) to address paediatric-specific clinical data requirementsDraft concept paperEMA/CHMP/213862/2016Released for consultation April 2016 Deadline for comments 31 July 2016
Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2) to address indication-specific clinical data requirements

Draft guideline

Concept paper

EMA/CHMP/776609/2011Released for consultation July 2012 Deadline for comments 31 January 2013
Evaluation of medicinal products indicated for treatment of bacterial infections

Adopted guideline

Draft guideline

Concept paper

CPMP/EWP/558/95 Rev. 2January 2012January 2012 
Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infectionsAdopted guidelineEMA/CHMP/351889/2013November 2013May 2014 
Revision of the addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium tuberculosisConcept paperCHMP/EWP/644851/2014Released for consultation 30 November 2014 Deadline for comments 28 February 2015
Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium tuberculosis

Adopted guideline

Draft guideline

Concept paper

CHMP/EWP/14377/2008January 2010August 2010 

 

How useful is this page?

Average rating:

 Based on 10 ratings

Add your rating:

See all ratings
3 ratings
0 ratings
0 ratings
3 ratings
4 ratings