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 (email@example.com) no longer exists. Therefore, please submit your comments from now on to the following e-mail address: firstname.lastname@example.org.
|Topic||Documents||Reference number||Publication date||Effective date||Remarks|
|Qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and analyses||Concept paper||EMA/CHMP/211243/2014||Released 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 tract||Concept paper||EMA/CHMP/558326/2013||Released for consultation October 2013||Deadline for comments 31 December 2013|
|Pharmacokinetic and clinical evaluation of modified-release dosage forms|
|EMA/CHMP/EWP/280/96 Rev. 1|
|Modified-release oral and transdermal dosage forms: Section II||Adopted guideline||EMA/CPMP/EWP/280/96/Corr.1 (28/05/09)||July 1999||January 2000|
|Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product|
|Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products||EMA/CHMP/37646/2009||Released for consultation April 2010||Deadline for comments 31 October 2010|
|Investigation of drug interactions||CPMP/EWP/560/95/Rev. 1||July 2012||January 2013|
|Investigation of drug interactions||Adopted guideline||CPMP/EWP/560/95|
|Investigation of bioequivalence||CPMP/EWP/QWP/1401/98 Rev. 1||January 2010||August 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|
|EMA/CHMP/600958/2010||November 2011||June 2012|
|Positions on specific questions addressed to the|
Pharmacokinetics Working Party
|EMA/618604/08 Rev. 9||May 2014|
|Bioanalytical method validation||EMEA/CHMP/EWP/192217/09||August 2011||February 2012|
|Clinical investigation of the pharmacokinetics of therapeutic proteins||CPMP/EWP/89249/04||February 2007||July 2007|
|Role of pharmacokinetics in the development of medicinal products in the paediatric population||CHMP/EWP/147013/04||July 2006||January 2007|
|Need to develop an appendix to the guideline on bioequivalence regarding the presentation of biopharmaceutical and bioanalytical data in application dossiers||Concept paper||EMA/CHMP/EWP/82259/2010||Released 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||CHMP/SWP/28367/07||July 2007||September 2007|
|Reporting the results of population pharmacokinetic analyses||CHMP/EWP/185990/06||July 2007||January 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 function||Adopted guideline||CPMP/EWP/2339/02||February 2005||August 2005|
|Need for revision of the note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function||Concept paper||EMA/CHMP/203926/2012||Released for consultation June 2012||Deadline for comments 31 July 2012|
|Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function||EMA/83874/2014 Rev1||Released 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 authorisation||Adopted guideline||CPMP/EWP/1875/03||December 2003||June 2003|
|Pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products||Adopted guideline||CPMP/EWP/2655/99||July 2000||February 2001|
|Need for revision of the note for guidance on modified-release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation)||Concept paper||EMA/CHMP/1303/2010||Released for consultation May 2010||Deadline for comments 31 August 2010|
|Pharmacokinetic studies in man||Adopted guideline||3CC3A||October 1998|
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