The World Health Organization (WHO) has unveiled its first global framework aimed at helping medicines regulators accelerate the transition to greener pharmaceuticals without compromising the quality, safety, efficacy or accessibility of medicine
The framework, titled “Towards a Greener Pharmaceuticals’ Regulatory Highway: A Framework for Regulators as Enablers of Decarbonization,” provides guidance on how regulatory systems can support sustainability-driven innovation throughout the pharmaceutical lifecycle while remaining firmly anchored in their core public health mandate.
Building on WHO’s greener pharmaceuticals’ regulatory highway call to action, launched in 2024, the framework is the outcome of extensive consultations with regulatory authorities, pharmaceutical manufacturers, international organizations, standards-setting bodies and technical experts worldwide, the Organization noted.
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 ensuring continued patient safety.
“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,” he added.
Healthcare’s Carbon Footprint
According to WHO, health systems account for approximately 5% of global greenhouse gas emissions, with pharmaceutical products contributing significantly through raw material sourcing, manufacturing, packaging, distribution, use and disposal. Climate change is also increasingly disrupting healthcare systems and pharmaceutical supply chains worldwide.
Three Pillars for Greener Pharmaceuticals
WHO’s framework for regulators proposes action across three interconnected pillars.
Awareness and capacity building: The organization calls for incorporating climate literacy into existing regulatory training and strengthening the ability to identify major emissions hotspots across pharmaceutical portfolios. The framework also encourages greater knowledge exchange through existing global and regional regulatory networks.
Guidance, tools and standards: The framework recommends stronger international alignment in measuring, reporting and comparing pharmaceutical emissions. It promotes the use of recognized standards, common methodologies and voluntary reporting mechanisms to improve transparency and consistency across markets while reducing duplication for both regulators and manufacturers.
Innovation and innovative regulatory pathways: The framework recommends expanding digital regulatory services, improving access to early scientific advice, streamlining sustainability-related post-approval changes, piloting collaborative regulatory approaches and strengthening reliance mechanisms among regulatory authorities to support faster adoption of environmentally beneficial innovations.
The framework draws on evidence gathered through literature reviews, stakeholder consultations, horizon scanning and discussions held during WHO’s Global Regulators Summit in June 2026. It emphasizes that pharmaceutical decarbonization will require “coordinated action across regulators, manufacturers, procurement agencies, governments, standards-setting bodies, multilateral organizations, researchers and civil society.”
Rather than creating new institutions, WHO plans to implement the framework through existing international and regional regulatory platforms.
The organization said it will work with national regulatory authorities, regional networks, the International Coalition of Medicines Regulatory Authorities (ICMRA), the International Council for Harmonisation (ICH) and other partners to promote knowledge sharing, pilot projects and greater alignment.
WHO added that it 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.
These efforts aim to ensure that future health products are not only safe, effective and accessible, but also aligned with the goals of a healthier planet.
