Environmental Risk Assessment (ERA) is playing an increasingly important role in pharmaceutical companies’ regulatory strategies. Long regarded as a documentation requirement linked to Marketing Authorization Applications (MAAs), it is now part of a broader regulatory and environmental landscape that continues to evolve.
The ongoing revision of the European pharmaceutical legislation and the growing attention given to topics such as persistent substances, endocrine disruptors, and antimicrobial resistance are contributing to the increased visibility of environmental considerations. For Regulatory Affairs, Pharmaceutical Development, and Pharmacovigilance teams, ERA is gradually becoming a lifecycle management issue that requires anticipation, scientific justification, and strategic thinking.
Environmental Assessment Has Become Unavoidable
The presence of pharmaceutical substances in the environment has become an increasingly scrutinized topic. The potential environmental impacts of a medicinal product may be considered at different stages of its lifecycle, from manufacturing to use and eventual disposal.
Within the regulatory framework applicable to human medicinal products, Environmental Risk Assessment primarily aims to evaluate the risks associated with environmental exposure to active substances following administration to patients. This approach is generally based on the assessment of environmental exposure, environmental fate, and potential ecotoxicological effects.
ERA is now an integral part of the development of many medicinal products and an important component of marketing authorization dossiers. Yet its implementation often raises questions that go beyond simple regulatory compliance: Which data should be used? Which methodology is the most appropriate? How should certain assumptions be justified? How can companies anticipate evolving regulatory expectations?
Regulatory Expectations Are Gradually Evolving
The European Medicines Agency (EMA) has provided guidance on the conduct of ERA for human medicinal products for many years. While the core principles are now well established, ongoing European regulatory discussions reflect a growing willingness to strengthen the consideration of environmental impacts.
This evolution is reflected in increasing attention to:
- PBT substances (Persistent, Bioaccumulative and Toxic) and vPvB substances (very Persistent and very Bioaccumulative);
- PMT substances (Persistent, Mobile and Toxic) and vPvM substances (very Persistent and very Mobile);
- Endocrine disruptors;
- Environmental risk mitigation measures;
- Risk-based approaches;
- The consideration of environmental data throughout the lifecycle of a medicinal product.
For pharmaceutical companies, the challenge is not only to understand what is expected today, but also to anticipate how these expectations may evolve in the coming years.
Balancing Available Data, Scientific Justification, and Operational Constraints
One of the main challenges faced by regulatory teams concerns the availability and robustness of environmental data.
In some projects, the necessary information is already available. In others, data gaps emerge and raise strategic questions:
- Should new data be generated?
- Are published literature data sufficient?
- How far should certain investigations be pursued?
- How should older data be managed in the context of evolving expectations?
These decisions can influence development timelines, resource allocation, and the overall regulatory strategy for a product.
Moreover, authorities are not only interested in the results obtained. They also expect a clear and coherent justification of the approach taken. Why were certain assumptions selected? Why were specific studies considered relevant? Do the available data adequately support the conclusions presented?
In many cases, the real challenge is not simply determining what should be done, but demonstrating that the chosen approach is scientifically sound and regulatorily defensible.
A Specific Case: Antimicrobials
Antimicrobials occupy a particular place in current discussions surrounding ERA.
The issue of antimicrobial resistance in the environment has led to a broader view of potential environmental risks, encompassing not only the use of the medicinal product itself, but also aspects related to manufacturing, supply chains, and disposal practices.
Where Atessia Can Help
Faced with evolving regulations and expectations that are not always straightforward to interpret, pharmaceutical companies often need to step back and identify the issues that truly matter for their products.
Atessia can support teams with:
- Analysis of the applicable regulatory framework;
- Critical review of existing ERAs;
- Identification of missing data and potential areas of concern;
- Assessment of the impact of regulatory developments or product changes;
- Preparation of scientific and regulatory justifications;
- Ensuring the overall consistency of dossiers.
The objective is not to apply a standardized solution, but to help teams build an approach that is tailored to their specific situation, thoroughly documented, and defensible before regulatory authorities.
Article written by Lamya Saoussen, Junior Regulatory Affairs and External Communications Consultant