WHO launches global framework for greener medicines regulation

The recommendations were shaped through scientific reviews, stakeholder consultations, horizon scanning and discussions during WHO's Global Regulators Summit in June 2026.

The World Health Organization (WHO) has introduced the world's first global framework to help medicines regulators support the shift towards lower-carbon pharmaceuticals while maintaining the highest standards of quality, safety, effectiveness and access. The new guidance encourages regulators to use existing regulatory tools to promote environmentally sustainable innovation without slowing the approval of essential medicines.

The framework, Towards a greener pharmaceuticals' regulatory highway, builds on WHO's 2024 call to action and was developed through consultations with regulators, pharmaceutical companies, international organisations, technical experts and standards bodies from around the world.

Helping medicines become more sustainable

Healthcare contributes around 5% of global greenhouse gas emissions, with pharmaceutical products generating emissions throughout their lifecycle, from sourcing raw materials and manufacturing to packaging, transport, use and disposal. At the same time, climate change is placing increasing pressure on health systems and disrupting medicine supply chains.

WHO says many technologies needed to reduce pharmaceutical emissions already exist. The challenge now is creating regulatory systems that encourage their wider adoption while ensuring medicines remain safe, effective and affordable. Dr Rogério Gaspar, Director of WHO's Department of Regulation and Prequalification, said regulators can play a major role in creating conditions that allow sustainable innovation to grow without compromising public health.

Three priorities for regulators

The framework outlines three key areas for action to support greener pharmaceutical systems.

The first focuses on awareness and capacity building, encouraging regulators to strengthen climate-related knowledge and improve their ability to identify major sources of emissions across pharmaceutical products.

The second promotes common guidance, standards and reporting methods so countries can measure and compare pharmaceutical emissions more consistently while reducing duplication for regulators and manufacturers.

The third encourages innovation through modern regulatory approaches, including expanded digital services, early scientific advice, streamlined approval processes for sustainability-related changes and stronger cooperation between regulatory authorities. WHO says these measures can help environmentally beneficial technologies reach patients more quickly while maintaining strict oversight.

Global cooperation at the heart of implementation

The recommendations were shaped through scientific reviews, stakeholder consultations, horizon scanning and discussions during WHO's Global Regulators Summit in June 2026. Rather than creating new institutions, WHO plans to work through existing international and regional regulatory networks, including the International Coalition of Medicines Regulatory Authorities and the International Council for Harmonisation.

The organisation will also support pilot projects, knowledge sharing and capacity-building activities to help countries put the framework into practice.

Equity remains a core principle

WHO stresses that the transition to greener pharmaceuticals must not increase medicine costs, disrupt supplies or disadvantage low- and middle-income countries. The framework calls for international cooperation, technology transfer, sustainable financing and stronger local manufacturing so every country can benefit from more sustainable pharmaceutical systems.

Dr Delese Mimi Darko, Director General of the African Medicines Agency, said regulators have an important role in shaping resilient health systems by embedding sustainability into regulatory frameworks while continuing to ensure patients have access to quality, safe and effective medical products.