The World Health Organization (WHO) has introduced the first global framework designed to help medicines regulators accelerate pharmaceutical decarbonization while ensuring that quality, safety, efficacy and equitable access to medicines remain fully protected. Titled Towards a greener pharmaceuticals’ regulatory highway: a framework for regulators as enablers of decarbonization, the initiative explains how regulatory systems can encourage sustainability-focused innovation throughout the pharmaceutical lifecycle without moving away from their primary public health responsibilities.
The framework builds upon WHO’s Greener pharmaceuticals’ regulatory highway call to action, introduced in 2024, following an extensive process involving evidence gathering and consultations with regulatory authorities, manufacturers, international organizations, standards-setting bodies and technical experts from around the world. It highlights how regulators can utilize existing tools—including standards, scientific guidance, reliance, digital transformation and innovative regulatory pathways—to encourage wider adoption of lower-carbon technologies while continuing to safeguard patients.
Dr. Rogério Gaspar, Director of WHO’s Department of Regulation and Prequalification, said, “The question is no longer whether pharmaceutical decarbonization is possible. The real challenge is how quickly and equitably we can make it a reality.”
“This framework demonstrates how medicines regulators can create the conditions for innovation to flourish while continuing to uphold the highest standards of quality, safety and efficacy. By making full use of existing regulatory tools, they can help advance more sustainable pharmaceutical systems that benefit both people and the planet,” he added.
Framework Outlines Regulatory Measures To Support Lower–Carbon Pharmaceutical Systems
WHO noted that health systems account for around 5% of global greenhouse gas emissions, with pharmaceutical products contributing significantly throughout their lifecycle, including raw material sourcing, manufacturing active ingredients, packaging, distribution, use and disposal. At the same time, climate change continues to disrupt health systems and pharmaceutical supply chains globally. Recognizing that many technologies and solutions required for pharmaceutical decarbonization are already available, the framework emphasizes creating regulatory conditions that encourage broader and more consistent adoption without introducing delays, fragmented requirements or barriers to access.
To achieve this, the framework is structured around three interconnected pillars:
- The first focuses on awareness and capacity building by encouraging climate literacy within existing regulatory training programmes and improving regulators’ ability to identify emissions hotspots across pharmaceutical portfolios while strengthening knowledge exchange through existing global and regional regulatory networks.
- The second pillar addresses guidance, tools and standards by recommending stronger international alignment in measuring, reporting and comparing pharmaceutical emissions through recognized standards, common methodologies and voluntary reporting mechanisms to improve transparency, consistency and reduce duplication for regulators and manufacturers.
- The third pillar concentrates on innovation and innovative regulatory pathways through expanded digital regulatory services, greater access to early scientific advice, streamlined sustainability-related post-approval changes, collaborative regulatory approaches and stronger reliance mechanisms, allowing environmentally beneficial innovations to move more efficiently through regulatory systems without compromising oversight.
Implementation Strategy Prioritizes Collaboration, Equity and Global Participation
The framework is the outcome of literature reviews, stakeholder consultations, horizon scanning and discussions held during WHO’s Global Regulators Summit in June 2026. These activities established broad international agreement that pharmaceutical decarbonization will require coordinated efforts involving regulators, manufacturers, procurement agencies, governments, standards-setting bodies, multilateral organizations, researchers and civil society.
Rather than establishing new institutions, WHO intends to implement the framework through existing international and regional platforms while working closely with national regulatory authorities, regional networks, the International Coalition of Medicines Regulatory Authorities, the International Council for Harmonisation and other partners to encourage knowledge sharing, pilot initiatives and greater regulatory alignment.
WHO further emphasized that the transition towards greener pharmaceuticals should remain just and inclusive through capacity building, technology transfer, sustainable financing and international collaboration. Looking ahead, the organization will continue working with regulators and partners worldwide to implement the framework through pilot projects, updated guidance, strengthened reliance mechanisms, capacity building and continued international dialogue to ensure future health products remain safe, effective, accessible and aligned with the goals of a healthier planet.
