Product-specific bioequivalence guidance

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This page lists the European Medicines Agency's scientific guidelines on product-specific bioequivalence guidance, which concern the study of medicines and their action in the human body.

As outlined in the “Compilation of individual product-specific guidance on demonstration of bioequivalence” draft guidances are published for public consultation individually on this page. After the public consultation period, overviews of comments are published individually with the draft guidances and the finalised guidances are published as annexes to the “Compilation of individual product-specific guidance on demonstration of bioequivalence”. Please refer to the compilation for all finalised guidances and their date for coming into effect.

If you have comments on a document that is open for consultation, use the form for submission of comments on scientific guidelines. If you have any other comments for the Pharmacokinetic Working Party, please submit them to the following e-mail address: pkwpsecretariat@ema.europa.eu

A questions-and-answers document is available on specific questions addressed to the Pharmacokinetics Working Party in relation to pharmacokinetic evaluations, which should be read in conjunction with the relevant scientific guidelines:

TopicDocumentsReference numberPublication dateEffective dateRemarks
Compilation of individual product-specific guidance on demonstration of bioequivalence

Guidance Rev. 3

Guidance Rev. 2

Guidance Rev. 1

Guidance

EMA/CHMP/736403/2014 Rev. 3

EMA/CHMP/736403/2014 Rev. 2

EMA/CHMP/736403/2014 Rev. 1

EMA/CHMP/736403/2014 

April 2016

July 2015

April 2015

December 2014

  

Draft guidances under public consultation

Everolimus product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/154772/2016May 2016 Deadline for comments 31 July 2016
Fingolimod product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/154812/2016May 2016 Deadline for comments 31 July 2016
Paliperidone product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/154812/2016May 2016 Deadline for comments 31 July 2016
Pazopanib product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/154805/2016May 2016 Deadline for comments 31 July 2016
Levodopa, Carbidopa, Entacapone product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/16289/2016May 2016 Deadline for comments 31 July 2016
Entecavir product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/PKWP/151748/2015 October 2015 Deadline for comments 1 January 2016
Lenalidomide product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/PKWP/152216/2015 October 2015 Deadline for comments 1 January 2016
Rivaroxaban product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/PKWP/151340/2015 October 2015 Deadline for comments 1 January 2016 
Tacrolimus granules product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/PKWP/36648/2015 October 2015  Deadline for comments 1 January 2016 
Ticagrelor product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/PKWP/151478/2015 October 2015  Deadline for comments 1 January 2016 
Asenapine product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/PKWP/269533/2015July 2015 Deadline for comments 1 November 2015
Prasugrel product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/PKWP/36761/2015July 2015 Deadline for comments 1 November 2015
Sitagliptin product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/PKWP/36869/2015July 2015 Deadline for comments 1 November 2015
Zonisamide product-specific bioequivalence guidanceDraft guidanceEMA/CHMP/PKWP/253507/2015July 2015 Deadline for comments 1 November 2015

Guidances after public consultation

To access all finalised guidances please refer to the “Compilation of individual product-specific guidance on demonstration of bioequivalence” at the top of this page.

Sunitinib product-specific bioequivalence guidance

Overview of comments

Draft guideline

CHMP/PKWP/EMA/423716/2013

July 2015

December 2013

  
Capecitabine product-specific bioequivalence guidance

Overview of comments

Draft guideline

CHMP/PKWP/EMA/423732/2013

July 2015

November 2013

  
Carglumic acid product-specific bioequivalence guidance

Overview of comments

Draft guideline

CHMP/PKWP/EMA/422457/2013

April 2015

November 2013

  
Dasatinib product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/423718/2013November 2013  
Emtricitabine/tenofovir disoproxil product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/423726/2013November 2013  
Erlotinib product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/418988/2013November 2013  
Imatinib product-specific bioequivalence guidance

Overview of comments

Draft guideline

CHMP/PKWP/EMA/423733/2013

April 2015

November 2013

  
Memantine product-specific bioequivalence guidance

Overview of comments

Draft guideline

CHMP/PKWP/EMA/423734/2013

April 2015

November 2013

  
Miglustat product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/422796/2013November 2013  
Oseltamivir product-specific bioequivalence guidance

Overview of comments

Draft guideline

CHMP/PKWP/EMA/423665/2013

April 2015

November 2013

  
Posaconazole product-specific bioequivalence guidance

Overview of comments

Draft guideline

CHMP/PKWP/EMA/423719/2013

April 2015

November 2013

  
Repaglinide product-specific bioequivalence guidanceDraft guidelineCHMP/PKWP/EMA/422421/2013November 2013  
Sirolimus product-specific bioequivalence guidance

Overview of comments

Draft guideline

CHMP/PKWP/422569/2013

July 2015

November 2013

  
Sorafenib product-specific bioequivalence guidance

Overview of comments

Draft guideline

CHMP/PKWP/EMA/423707/2013

July 2015

November 2013

  
Tadalafil product-specific bioequivalence guidance

Overview of comments

Draft guideline

CHMP/PKWP/EMA/423735/2013

July 2015

November 2013

  
Telithromycin product-specific bioequivalence guidance

Overview of comments

Draft guideline

CHMP/PKWP/EMA/422605/2013

July 2015

November 2013

  
Voriconazole product-specific bioequivalence guidance

Overview of comments

Draft guideline

CHMP/PKWP/EMA/422408/2013

July 2015

November 2013

  
Development of product-specific guidance on demonstration of bioequivalenceConcept paperEMA/CHMP/423137/2013Released for consultation August 2013 Deadline for comments 30 September 2013

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