The European Medicines Agency has taken steps to innovate its regulatory procedures with two pilot programmes that will, on the one hand, align with the US Food and Drug Administration’s plans to reduce animal studies in drug development and on the other, to conduct structured dialogues with companies on the requirements for marketing authorisation applications. In the first case, the goal is to modernise pre-clinical tests for new drugs. In the second, it is to create space for more interactions between the agency and companies prior to the submission of formal applications.
