The WHO, through its Department of Regulation and Prequalification, has launched a call for action to promote sustainability in the pharmaceutical sector. The initiative, titled ‘Greener pharmaceuticals’ regulatory highway,’ highlights the need for innovative regulatory practices that reduce the environmental footprint of medical products while ensuring safety and efficacy.

Dr Yukiko Nakatani, WHO Assistant Director-General, emphasized, ‘Addressing the environmental impact of healthcare products is imperative,’ noting that transforming regulatory practices is essential for a sustainable pharmaceutical industry.

Drug development is among the highest producers of greenhouse gas (GHG) emissions, with about 4.4%–4.6% of the worldwide GHG emissions coming from the thousands of clinical trials being carried out annually by the pharmaceutical industry [1]. 

This call urges regulatory bodies and stakeholders to adopt sustainable practices. Key proposals outlined in the initiative include: 1) creating new standards for sustainable manufacturing, packaging, and distribution of medical products; 2) leveraging digital tools to enhance regulatory processes, especially in low- and middle-income countries; and 3) streamlining procedures to accelerate eco-friendly innovations.

The pharmaceutical sector can mitigate its environmental impact by adopting cleaner production techniques, redesigning synthetic processes, and investing in renewable energy for manufacturing. WHO also advocates for greater transparency and accountability in supply chain practices and sustainable procurement standards to promote green solutions.

This call aligns with frameworks like the WHO Global Strategy on Health, Environment, and Climate Change and builds on findings from reports such as Unitaid’s 2023 study ‘From milligrams to megatons,’ which showed that up to 95% of greenhouse gas emissions for certain medicines come from raw material acquisition and manufacturing. This stresses the urgent need for sustainability-driven research and development in active pharmaceutical ingredients and manufacturing processes.

WHO plans to release a white paper on sustainable regulatory practices for discussion at a global summit in late 2025, aiming to drive long-term change in the pharmaceutical supply chain.

Pharma companies aiming for net-zero carbon emissions by 2040 must align ESG (environmental, social, and governance) strategies with clinical development, emphasizing efficient operations and innovative, customized trial designs. Streamlined, scientifically sound clinical trials can support global efforts to limit carbon emissions. Encouraging trialists to estimate and highlight the carbon footprint reduction of planned trials during grant applications is vital. Tools to measure trial carbon footprints and identify elements that advance ESG goals are urgently needed. Collaboration among researchers, funders, ethicists, regulators, policymakers, and industry representatives is essential to achieve and sustain these goals [1]. 

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Reference
1. Mittra S, et al. Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials. Generics and Biosimilars Initiative Journal (GaBI Journal). 2024;13(3):142-51.doi:10.5639/gabij.2024.1303.033

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