A pharmaceutical process is developed, studied, validated and kept under control precisely to ensure that it cannot change without the consequences being assessed. This is one of the foundations of pharmaceutical quality. But what happens when that process needs to change in order to reduce its environmental impact?
Replacing a solvent, reducing the energy consumption of a manufacturing step, changing a material, modifying packaging or introducing a more efficient technology can improve the environmental profile of a medicinal product. At the same time, however, such changes may also affect process parameters, stability, product quality, the supply chain and regulatory documentation.
It is within this space between the need to change and the need to maintain control that the framework published by the World Health Organization on 29 July 2026, Towards a greener pharmaceuticals’ regulatory highway: a framework for regulators as enablers of decarbonization, comes into play.
Its aim is to explore how regulatory systems can enable innovations that reduce the climate impact of medicines while maintaining standards of quality, safety and efficacy, without compromising access to and availability of treatments. From this perspective, sustainability ceases to be an external variable and becomes part of the product lifecycle.
Towards a greener pharmaceuticals’ regulatory highway
The issue is not simply about using less
When discussing industrial decarbonization, energy is often the first consideration: more efficient facilities, electricity from renewable sources, lower consumption and heat recovery. In the pharmaceutical sector, however, the issue can go much deeper.
In the discussion convened by the WHO in 2026, manufacturing — and particularly the production of active pharmaceutical ingredients — was identified as one of the key hotspots requiring action. Reducing environmental impact may call for more efficient synthesis routes, fewer manufacturing steps, solvent recovery, process intensification, new technologies or different operating conditions.
This is where a specifically pharmaceutical challenge emerges. A process with a lower environmental impact cannot be adopted simply because it uses less energy or generates less waste. It must still be capable of consistently producing a medicinal product that meets the expected quality requirements.
Environmental considerations therefore inevitably intersect with pharmaceutical ones
Changing while demonstrating what remains unchanged
Throughout the lifecycle of a medicinal product, changes are normal. Manufacturing sites, equipment, suppliers, production scales and technologies may all change over time. The system already provides tools to assess their impact through the pharmaceutical quality system, change control, risk assessment and post-approval procedures.
Decarbonization introduces an additional reason for using these same tools. A process may be modified because a more robust or productive technology becomes available. Increasingly, it may also be changed because an alternative can achieve the same result with a lower environmental footprint.
This does not reduce the need to demonstrate that the change remains under control. Sustainability does not become an exception to the rules of pharmaceutical quality; rather, it becomes one of the reasons why the product lifecycle must be able to evolve.
When the regulatory system can help
The WHO framework starts from an important observation: regulators can contribute to decarbonization by using tools that are already part of pharmaceutical regulation.
The document identifies three areas for action: capability building; guidance, tools and standards; and innovation through regulatory pathways. Among the opportunities highlighted are scientific advice, digital transformation, reliance, international collaboration and greater harmonization.
The aim is not to make the assessment of lower-impact changes less rigorous, but to prevent uncertainty, fragmentation or duplication of requirements from becoming unnecessary barriers.
For a global industry, this is particularly relevant. A manufacturing change may affect a medicinal product registered in multiple markets. Significant differences in requirements across jurisdictions can make it difficult to introduce a more sustainable solution even when its technical validity has already been demonstrated.
Harmonization therefore becomes one of the conditions that can make change practically achievable.
The risk of freezing what already works
There is a paradox. The more mature, validated and widely distributed a pharmaceutical process is across multiple markets, the greater the technical and regulatory cost of changing it may become. Yet it is precisely established products manufactured at high volumes that may offer significant opportunities to reduce environmental impact.
The risk is a form of industrial inertia: continuing to use a solution because it is already known, qualified and authorized, even when potentially better alternatives are available.
This does not mean that every process should be changed. The environmental benefit must justify the change and be assessed alongside other risks. A solution that reduced emissions but significantly increased the risk of shortages, for example, could hardly be considered sustainable in the broader sense of the term.
The WHO specifically emphasizes the need to consider decarbonization together with quality, access and security of supply.
Sustainability begins with development
If modifying an established process can be complex, it becomes even more important to consider its environmental impact during pharmaceutical development and process development.
The synthetic route, solvents, number of process steps, energy consumption, raw materials, packaging and supply chain design can also be evaluated in light of the product’s future environmental footprint. Not to replace traditional quality and performance attributes, but to add another variable to development decisions.
This also changes the meaning of process innovation. A technology can generate value because it increases yield and robustness or reduces time and costs; it can also generate value because it enables lower use of energy, water or solvents and generates less waste.
Sustainability and process understanding therefore converge: it is difficult to rationally reduce the impact of a process that is not well understood.
Measure before choosing
Transformation, however, requires a common basis. The WHO emphasizes the need for harmonized definitions, standards and methodologies to measure pharmaceutical emissions and identify hotspots across the lifecycle.
This is also an essential step for procurement. If healthcare systems and major purchasers begin to consider environmental performance in their decisions, sufficiently robust and comparable data will be needed.
Without shared metrics, there is a risk that sustainability will remain dependent on indicators that are difficult to compare or on corporate claims that do not make it possible to distinguish between genuine improvements and methodological differences.
A lifecycle capable of evolving
For decades, an important part of pharmaceutical regulation has been built around an essential question: how can we change something without compromising what we know about the product?
Decarbonization does not replace that question. It adds another one: how can we prevent the need to preserve what we know from preventing us from improving what we can?
A more sustainable medicine does not necessarily begin with a new molecule or an entirely different manufacturing facility. It may result from a series of interventions distributed throughout the lifecycle: a more efficient process, fewer solvents, lower energy use, redesigned packaging or a more rational supply chain.
Each change must be technically justified and appropriately controlled. But the system must also be able to enable it.
Because if sustainability becomes one of the criteria by which we assess the overall quality of a manufacturing system, then the ability to change without losing control also becomes part of its performance.
