The World Health Organization (WHO) today launched the first global framework to help medicines regulators accelerate the transition towards greener pharmaceuticals without compromising quality, safety, efficacy or equitable access.
Towards a greener pharmaceuticals' regulatory highway: a framework for regulators as enablers of decarbonization sets out how regulatory systems can support sustainability-driven innovation across the pharmaceutical lifecycle while remaining firmly anchored in their core public health mandate.
The framework builds on WHO's Greener pharmaceuticals' regulatory highway call to action, launched in 2024, and reflects a comprehensive process of evidence gathering and consultation with regulatory authorities, manufacturers, international organizations, standards-setting bodies and technical experts worldwide.
Working within the established mandate of medicines regulators, the framework outlines how existing regulatory tools, including standards, scientific guidance, reliance, digital transformation and innovative regulatory pathways, can help accelerate the adoption of lower-carbon technologies while continuing to protect patients.
"The question is no longer whether pharmaceutical decarbonization is possible. The real challenge is how quickly and equitably we can make it a reality,” said Dr Rogério Gaspar, Director of WHO's Department of Regulation and Prequalification. “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."
Turning ambition into action
Health systems account for around 5% of global greenhouse gas emissions, with pharmaceutical products contributing an important share of that footprint through their lifecycle – from sourcing raw materials and manufacturing active ingredients to packaging, distribution, use and disposal. At the same time, climate change is increasingly disrupting health systems and pharmaceutical supply chains worldwide.
Recognizing that many of the solutions needed to decarbonize pharmaceutical value chains already exist, the framework focuses on creating the regulatory conditions needed to enable their wider and more consistent adoption without creating delays, fragmented requirements or barriers to access.
The framework proposes action across three interconnected pillars.
Awareness and capacity building: WHO calls for climate literacy to be incorporated into existing regulatory training and for authorities to strengthen their ability to identify major emissions hotspots across pharmaceutical portfolios. The framework also promotes greater knowledge exchange through existing global and regional regulatory networks.
Guidance, tools and standards: The framework recommends stronger international alignment on how pharmaceutical emissions are measured, reported and compared. Greater use of recognized standards, common methodologies and voluntary reporting mechanisms could improve transparency and consistency across markets while reducing duplication for both regulators and manufacturers.
Innovation and innovative regulatory pathways: Key recommendations include expanding digital regulatory services, increasing access to early scientific advice, streamlining sustainability-related post-approval changes, piloting collaborative regulatory approaches and strengthening reliance mechanisms between authorities. These measures could help environmentally beneficial innovations move through regulatory systems more efficiently while maintaining robust oversight.
From consultation to implementation
The framework reflects evidence gathered through literature reviews, stakeholder consultations, horizon scanning and WHO's Global Regulators Summit held in June 2026. Together, these activities helped build international consensus that pharmaceutical decarbonization will require coordinated action across regulators, manufacturers, procurement agencies, governments, standards-setting bodies, multilateral organizations, researchers and civil society.
The framework therefore calls for implementation through existing international and regional platforms rather than the creation of new institutions. WHO will work with national regulatory authorities, regional networks, the International Coalition of Medicines Regulatory Authorities, the International Council for Harmonisation and other partners to support knowledge sharing, pilot initiatives and greater alignment.
A transition that leaves no one behind
Equity and access are central to the framework. Sustainability measures must not increase the cost of medicines, undermine supply or exclude manufacturers and regulators in low- and middle-income countries from the transition.
“As regulators, we are not passive actors in this system; we are architects of it,” said Dr Delese Mimi Darko, Director General of the African Medicines Agency. “By embedding sustainability into our regulatory frameworks, we can support innovation, strengthen local manufacturing and build more resilient health systems that ensure patients continue to have access to quality safe and efficacious medical products."
The transition towards greener pharmaceuticals must be just and inclusive, supported by capacity building, technology transfer, sustainable financing and international collaboration, so that all countries can contribute to – and benefit from – a more sustainable pharmaceutical future.
Looking ahead, WHO will continue working with regulators and partners worldwide to translate the framework’s recommendations into practical action through pilot projects, updated guidance, capacity building, strengthened reliance mechanisms and continued international dialogue, helping ensure that future health products are not only safe, effective and accessible, but also aligned with the goals of a healthier planet.