Review of the 2008 European Medicines Agency concept paper on bioanalytical method validation

“If an EMEA document leads to contradictions between agencies, this will be in the interest of no-one...” The EMEA recognizes the importance of bioanalytical data that is included in medicinal product applications. However, the Committee for Medicinal Products for Human Use (CHMP) does not currently have guidance on the validation and use of bioanalytical methods. Therefore, the EMEA published a concept paper in December 2008 on the need for CHMP guidelines on this particular topic, as a discussion document [101]. The timing of the release of the EMEA concept paper is interesting as it was published against the backdrop of...