The EMEA CHMP Efficacy Working Party Publish Q&A’s

Questions & Answers: Positions on specific questions addressed to the EWP therapeutic subgroup on Pharmacokinetics.

In the context of assessment procedures, 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 EWP-PK subgroup 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. 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. As the questions have initially been raised in the context of specific assessment procedures, details of these procedures have been redacted for reasons ofconfidentiality.
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 Likewise, if a  position is being considered outdated, e.g. due to new evolutions in the scientific knowledge including  revisions to the applicable guidelines, positions will be removed from this document.  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.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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