[DIA Europe 2024] Complexity: Interplay and Interface of Different Legislations

The EU landscape of policies and regulations governing medicines research, development and manufacturing becomes increasingly complex. Products become more complex and more often than not consist of components regulated by different policies. But there are also unintended consequences where there is a pre-existing link between, for example, food and pharmaceutical rules, or where such link is created when new rules are set up. Developers of medicines must keep an eye not only on the legislation and guidance directly governing pharmaceutical products R&D and manufacturing but also on the interplay between other sectorial policies and legislations driven by considerations specific to food, device, diagnostics, chemicals, environment, data, etc. As a result, these other policies and regulations can either add to the evidence requirements increasing complexity and cost, or even contradict in some instances the principles on which medicines quality, safety and efficacy rely. The session will bring together medicine developers, policymakers, national and European regulators from different domains, patients and academics to shed light on examples of such complexities, their impact, pragmatic mitigation measures and general principles that should drive policy development to avoid that complexity turns into complications that prevent R&D or manufacturing in Europe.