Towards a greener pharmaceuticals' regulatory highway: a framework for regulators as enablers of decarbonization

This framework provides a roadmap for how pharmaceutical regulatory systems can support innovation that reduces the climate impact of medicines for human use while maintaining standards of safety, quality and efficacy and ensuring timely, affordable and equitable access for patients. Developed as a follow-up to the WHO Call for Action on a greener pharmaceuticals' regulatory highway (2024), it examines the contribution of pharmaceutical products to greenhouse gas emissions across their life cycle and explores how existing regulatory functions can facilitate decarbonization without expanding regulatory mandates or compromising public health objectives, access, affordability or supply security. Organized around three pillars—awareness and capacity-building; guidance, tools and standards; and innovation through regulatory pathways—the framework identifies opportunities to strengthen regulatory capabilities, promote internationally aligned methodologies and reporting approaches, expand digital transformation, scientific advice, reliance mechanisms and collaborative initiatives, and support sustainability-driven innovation. It concludes that coordinated action by regulators, WHO and other stakeholders is essential to advance lower-carbon pharmaceutical systems while building on existing regulatory frameworks and partnerships.