Closing the gap – validating and implementing new approach methodologies in a regulatory context

The German Federal Ministry of Education and Research (BMBF) and the Dutch organisation for knowledge and innovation in health, healthcare and well-being (ZonMw) launched a joint call for interdisciplinary research projects with a focus on method validation to further strengthen this field in Europe and to foster and consolidate a sustainable research cooperation between Germany and the Netherlands. This call aims to validate new approach methods in a regulatory context, with the ultimate goal to implement new animal-free, human relevant methods as OECD guidelines or establish qualified models to be used in efficacy testings for new pharmaceuticals.

In this regard projects are expected to increase in technology readiness levels during the duration of the project, thus enabling them to prepare documentation for a timely (2-3 years post project finalisation) regulatory evaluation and approval, if feasible.