BEBAC  Ing. Helmut Schütz

Questions & Answers


The EMA’s CHMP/EWP Pharmacokinetics Working Party (PKWP) published ‘Questions & Answers: Positions on specific questions addressed to the Pharmacokinetics Working Party’ EMEA/618604/2008 Rev. 13 (19 November 2015, published 03 March 2016; for pre­vious versions see the end of the page).


In the context of assessment procedures, the Pharmacokinetics Working Party (PKWP), or its predecessor the Therapeutic Subgroup on Pharmacokinetics of the Efficacy Working Party (EWP-PK subgroup), is occasionally consulted by the CHMP or, following CHMP’s agreement, by other Committees, Working parties or the CMD(h). The objective is to address specific questions in relation to pharmacokinetic evaluations and particularly the requirements and assessment of bioequivalence studies. The positions, which are being elaborated by the PKWP in response to such questions, are being forwarded to the en­quir­ing party for consideration in their assessment.

It is understood that such position will be reflected in the procedure-related assessment reports if applicable. In some cases however, these position might also be of more general interest as they interpret a very specific aspect that would not necessarily be covered by guidelines. This paper summarises these positions which have been identified as being with­in this scope. In addition, general clarifications related to guidelines authored by the PKWP are subject to specific positions in this paper.

It should be noted that these positions are based on the current scientific knowledge as well as regulatory precedents. They should be read in conjunction with the applicable guidelines on bioequivalence in their current version. If the questions have initially been raised in the context of specific assessment procedures, details of these procedures have been redacted for reasons of confidentiality.

This compilation will be updated with new positions as soon as they become available. Like­wise, if a position is being considered outdated, e.g. due to new evolutions in the scientific knowledge including revisions to the applicable guidelines, positions will be removed from this document. Positions previously prepared by the EWP-PK subgroup are endorsed by the current PKWP unless removed from this document.

The positions in this document are addressing very specific aspects. They should not be quoted as product-specific advice on a particular matter as this may require reflection of specific data available for this product. By no means should these positions be understood as being legally enforceable.

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# Edition/Revision Date
1 First version 87KB 2009-01-22
2 First version, update 94KB 2009-06-22
3 Revision 01 89KB 2009-07-23
4 Revision 02 182KB 2010-07-22
5 Revision 03 195KB 2011-01-26
6 Revision 04 282KB 2012-02-16
7 Revision 05 419KB 2012-09-20
8 Revision 06 300KB 2012-12-10
9 Revision 07 403KB 2013-02-13
10 Revision 08 452KB 2013-10-10
11 Revision 09 479KB 2014-05-02
12 Revision 10 494KB 2014-10-07
13 Revision 11 535KB 2015-01-22
14 Revision 12 507KB 2015-06-25
15 Revision 13 473KB 2015-11-19