Medicines regulators can use existing regulatory tools to support the adoption of lower-carbon technologies while continuing to protect quality, safety, efficacy and equitable access. The World Health Organization (WHO) has launched a global framework for greener pharmaceuticals across the pharmaceutical lifecycle. It builds on a WHO call to action launched in 2024 and reflects evidence gathering and consultation with regulatory authorities, manufacturers, international organisations, standards-setting bodies and technical experts worldwide. Existing tools identified include standards, scientific guidance, reliance, digital transformation and innovative regulatory pathways, with the aim of enabling sustainability-driven innovation within regulators’ established public health mandate.
Building Regulatory Capacity for Decarbonisation
Health systems account for around 5% of global greenhouse gas emissions, and pharmaceutical products contribute an important share through their lifecycle. Emissions are associated with activities including sourcing raw materials, manufacturing active ingredients, packaging, distribution, use and disposal. Climate change is also increasingly disrupting health systems and pharmaceutical supply chains worldwide.
Many solutions needed to decarbonise pharmaceutical value chains already exist. Wider and more consistent adoption depends on regulatory conditions that do not create delays, fragmented requirements or barriers to access. Medicines regulators can use established regulatory tools to support lower-carbon technologies while continuing to protect patients.
Awareness and capacity building form one area of action. Climate literacy can be incorporated into existing regulatory training, and authorities can strengthen their ability to identify major emissions hotspots across pharmaceutical portfolios. Greater knowledge exchange can also take place through existing global and regional regulatory networks.
Training can therefore include climate literacy, while regulators can strengthen their ability to identify where major emissions occur across pharmaceutical portfolios. Existing global and regional regulatory networks can support greater knowledge exchange. Regulatory tools can be used to accelerate the adoption of lower-carbon technologies while medicines regulators continue to work within their established mandate and protect quality, safety, efficacy and access.
Aligning Standards and Regulatory Pathways
Stronger international alignment is recommended for the measurement, reporting and comparison of pharmaceutical emissions. Recognised standards, common methodologies and voluntary reporting mechanisms can improve transparency and consistency across markets. They can also reduce duplication for regulators and manufacturers.
Innovation and innovative regulatory pathways form another area of action. Measures include expanding digital regulatory services, increasing access to early scientific advice and streamlining sustainability-related post-approval changes. Collaborative regulatory approaches can also be piloted, while reliance mechanisms between authorities can be strengthened. These measures are intended to help environmentally beneficial innovations move through regulatory systems more efficiently while maintaining robust oversight.
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Existing standards, scientific guidance, reliance, digital transformation and innovative regulatory pathways can be used to support lower-carbon technologies. These measures remain within the established mandate of medicines regulators, with quality, safety and efficacy continuing to be protected.
Post-approval changes related to sustainability can be streamlined, and access to early scientific advice can be expanded. Collaborative regulatory approaches and reliance between authorities can support environmentally beneficial innovations moving through regulatory systems more efficiently while maintaining robust oversight.
Regulatory conditions are intended to enable wider adoption without creating delays, fragmented requirements or barriers to access. Common approaches to emissions measurement and reporting can support greater transparency and consistency across markets while reducing duplication for both regulators and manufacturers.
Using Existing Networks for Implementation
Implementation is intended to take place through existing international and regional platforms rather than through new institutions. WHO plans to work with national regulatory authorities, regional networks, the International Coalition of Medicines Regulatory Authorities, the International Council for Harmonisation and other partners. Activities include knowledge sharing, pilot initiatives and greater alignment.
The underlying process included literature reviews, stakeholder consultations, horizon scanning and the WHO Global Regulators Summit held in June 2026. It involved regulatory authorities, manufacturers, international organisations, standards-setting bodies and technical experts. Coordinated action is expected to involve regulators, manufacturers, procurement agencies, governments, standards-setting bodies, multilateral organisations, researchers and civil society.
Equity and access are central conditions. 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. A just and inclusive transition is to be supported by capacity building, technology transfer, sustainable financing and international collaboration.
Knowledge sharing and pilot initiatives are to be supported through national regulatory authorities, regional networks and international partners. Continued international dialogue is also planned as the recommendations are translated into practical action.
WHO plans continued work with regulators and partners worldwide through pilot projects, updated guidance, capacity building, strengthened reliance mechanisms and continued international dialogue. These activities are intended to translate the recommendations into practical action while maintaining requirements for health products to remain safe, effective and accessible.
Greener pharmaceutical regulation is intended to use existing regulatory mandates, tools and international or regional platforms. Key areas include climate literacy, identification of emissions hotspots, greater alignment in emissions measurement and reporting, digital regulatory services, scientific advice, collaborative approaches and stronger reliance between authorities. Implementation includes knowledge sharing, pilot initiatives, updated guidance and capacity building. Quality, safety, efficacy and equitable access remain central, while sustainability measures must not increase medicine costs, undermine supply or exclude manufacturers and regulators in low- and middle-income countries from the transition.
Source: World Health Organization
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