Clinical efficacy and safety: Clinical pharmacology and pharmacokinetics

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This page lists the European Medicines Agency's scientific guidelines on clinical pharmacology and pharmacokinetics, which concern the study of medicines and their action in the human body.

There is a separate a list on product-specific bioequivalence guidance.

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: pkwpsecretariat@ema.europa.eu.

TopicDocumentsReference numberPublication dateEffective dateRemarks
Qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and analysesConcept paper EMA/CHMP/211243/2014Released for consultation June 2014 Deadline for comments 30 September 2014
Development of a guideline on the demonstration of therapeutic equivalence for locally applied and locally acting products in the gastrointestinal tractConcept paperEMA/CHMP/558326/2013Released for consultation October 2013 Deadline for comments 31 December 2013
Pharmacokinetic and clinical evaluation of modified-release dosage forms

Adopted guideline

Draft guideline

 

EMA/CHMP/EWP/280/96 Rev. 1

November 2014

 

June 2015

 

 
Modified-release oral and transdermal dosage forms: Section IIAdopted guidelineEMA/CPMP/EWP/280/96/Corr.1 (28/05/09)July 1999January 2000 
Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product

Overview of comments

Adopted reflection paper

Draft reflection paper

EMA/CHMP/806058/2009/Rev. 2

 

March 2013  
Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products

Adopted guideline

Draft guideline

Concept paper

EMA/CHMP/37646/2009Released for consultation April 2010 Deadline for comments 31 October 2010
Investigation of drug interactions

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CPMP/EWP/560/95/Rev. 1July 2012January 2013 
Investigation of drug interactionsAdopted guidelineCPMP/EWP/560/95   
Investigation of bioequivalence

Overview of comments

Adopted guideline

Draft guideline

Concept paper

Concept paper

CPMP/EWP/QWP/1401/98 Rev. 1January 2010August 2010 
Appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1

Overview of comments

Adopted guideline

Draft guideline

 

EMA/CHMP/600958/2010November 2011June 2012 
Positions on specific questions addressed to the
Pharmacokinetics Working Party

Questions and answers

EMA/618604/08 Rev. 9May 2014  
Bioanalytical method validation

Overview of comments

Adopted guideline

Draft guideline

Concept paper

EMEA/CHMP/EWP/192217/09August 2011February 2012 
Clinical investigation of the pharmacokinetics of therapeutic proteins

Overview of comments

Adopted guideline

Draft guideline

CPMP/EWP/89249/04February 2007July 2007 
Role of pharmacokinetics in the development of medicinal products in the paediatric population

Overview of comments

Adopted guideline

CHMP/EWP/147013/04July 2006January 2007 
Need to develop an appendix to the guideline on bioequivalence regarding the presentation of biopharmaceutical and bioanalytical data in application dossiersConcept paperEMA/CHMP/EWP/82259/2010Released for consultation April 2010 Deadline for comments 31 July 2010
Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products

Overview of comments

Adopted guideline

Draft guideline

CHMP/SWP/28367/07July 2007September 2007 
Reporting the results of population pharmacokinetic analyses

Overview of comments

Adopted guideline

Draft guideline

CHMP/EWP/185990/06July 2007January 2008 
Addendum to the note for guidance on the investigation of bioavailability and bioequivalence: Evaluation of bioequivalence of highly variable drugs and drug products CHMP/EWP/147231/06  Deleted.
This topic will be addressed in the revision of the note for guidance on the investigation of bioavailability and bioequivalence (CHMP/EWP/200943/07)
Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic functionAdopted guidelineCPMP/EWP/2339/02February 2005August 2005 
Need for revision of the note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal functionConcept paperEMA/CHMP/203926/2012Released for consultation June 2012 Deadline for comments 31 July 2012
Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function

Draft guideline

Adopted guideline

EMA/83874/2014 Rev1Released for consultation March 2014 Dealine for comments 31 August 2014
Points to consider on the clinical requirements of modified-release products released as a line extension of an existing marketing authorisationAdopted guidelineCPMP/EWP/1875/03December 2003June 2003 
Pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal productsAdopted guidelineCPMP/EWP/2655/99July 2000February 2001 
Need for revision of the note for guidance on modified-release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation)Concept paperEMA/CHMP/1303/2010Released for consultation May 2010 Deadline for comments 31 August 2010
Pharmacokinetic studies in manAdopted guideline3CC3AOctober 1998