Recognising both the promise of these complex products and the unique challenges they pose, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have existing guidance to facilitate their development. While both regulators share core principles, there are meaningful differences in their respective regulatory frameworks. To advance shared understanding and support pharmaceutical developers navigating this evolving landscape, we are organising a workshop offering a practical exploration of regulatory considerations for herbal medicinal / botanical drug products intended for medicinal use.