Towards a European regulatory framework for medicinal products with a whole system background

The European Union (EU) has a policy to improve the health of its citizens and to guarantee the sustainability of the health-care systems in its member states. One topic currently insufficiently met by the EU is the testing and licensing of medicinal products (MPs) with a ‘whole system’ background (e.g., anthroposophic medicine and traditional Chinese medicine). In this presentation, based on the scientific literature on whole systems research, we propose a framework for a permanent licensing system for ‘whole system MPs’ in Europe, including models for evidence grading and licensing categories.