Publication / Source: Bioanalysis 4(8)
Authors: Smith G
“Overall, the content of the European Medicines Agency guideline is not dramatically different to that of the US FDA Guidance and supporting White Papers.”
The European Medicines Agency (EMA) published a draft guideline on bioanalytical method validation in November 2009 (hereafter referred to as the ‘Guideline’) and following a consultation period until the end of May 2010, the final Guideline was adopted in July 2011 and became effective on 1 February 2012. Until the implementation of the Guideline, the US FDA 2001 ‘Guidance for Industry’ on this topic was almost universally adopted by the pharmaceutical and contract-research industries as the standard approach for validating and implementing bioanalytical methods that are used to generate data to support medicinal product applications.