Building the Global Bioanalysis Consortium - working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation.

Although harmonization of bioanalytical method validation (BMV) and application has been dis­ cussed at scientific forums on several occasions, it was not until the European Bioana lysis Forum (EBF) conference in December 2009 [1], where the European Medicines Agency’s (EMA) intended draft bioanalytical method validation guide­ line [101] was discussed, that the bioanalytical scientists present expressed their strong wish for international harmonization. CT Viswanathan (US FDA/Center for Drug Evaluation and Research [CDER]) and J Welink (Dutch Medicines Evaluation Board [MEB] for EMA), present at the meeting, acknowledged this need for harmonization and encouraged representatives of several international organisations – American Association of Pharmaceutical Scientists (AAPS), Applied Pharmaceutical Analysis (APA), Calibration Validation Group (CVG) and EBF – to work with their respective memberships and collaborate on global BMV harmonization efforts. Specifically, both agency representatives said they would be open to h earing from the international scientific community proposals for consistent h armonized regulatory language. The first action in this direction was to pub­ lish the open letter that they had sent to the US FDA and EMA in February 2010, requesting global harmonization of existing or emerging guidances for BMV and sample ana lysis and offering to support the processes needed [2]. In addition, representatives of the above named organizations published two editorials in the same journal discussing the history of BMV and expressing their views on a future harmonization process [3,4]. Concurrent with these publications, the CVG had its fourth workshop on regulated bioana­ lysis in Montreal. This meeting focussed seri­ ous attention on the topic of harmonization of bioanalytical guidelines through a number of speakers from industry and regulatory agencies presenting their ideas and discussing possible future processes with the audience [5]. At the CVG workshop, a unanimous consensus was reached among the five regulatory agencies, the panellists and the international audience that global guidance should be science driven, not prescriptive, and should include rationale behind each requirement to prevent ‘box checking’ by auditors and reviewers of filings. Furthermore, the need to rise above local issues and focus on globally acceptable language will be pivotal to a successful outcome.