EMA Environmental Risk Assessment (ERA) Guideline

The European Medicines Agency (EMA) has introduced an updated Environmental Risk Assessment (ERA) Guideline, effective September 2024, reshaping how pharmaceutical companies evaluate and mitigate the environmental impacts of their products.

The new framework reinforces scientific rigor, transparency, and pharmaceutical sustainability, ensuring that every human medicinal product (HMP) undergoes a systematic and evidence-based assessment of its potential ecological risks. This revision marks a pivotal step in aligning the pharmaceutical sector with Europe’s broader Green Deal ambitions and rising expectations for environmental stewardship.

Understanding Environmental Risk Assessment (ERA)

An Environmental Risk Assessment (ERA) evaluates the potential impact of a pharmaceutical active substance on the environment, including surface water, groundwater, soil, and biodiversity.

The assessment examines how a substance behaves once excreted, released, or disposed of, focusing on:

• Physico-chemical properties (e.g., solubility, degradation pathways)

• Ecotoxicological effects (e.g., toxicity to aquatic and terrestrial organisms)

• Environmental fate (e.g., persistence, mobility, bioaccumulation)

Under the 2024 EMA ERA guideline, a complete ERA is required for all Marketing Authorisation Applications (MAAs) for human medicinal products, including new, generic, and hybrid applications.

Key Highlights of the EMA Environmental Risk Assessment Guideline 2024

1. Mandatory ERA for All Human Medicinal Products

All MAAs—across centralized, decentralized, and mutual recognition procedures—must include a full ERA dossier (Module 1.6 of the eCTD).Additionally, type II variations or new indications that could increase environmental exposure require an updated ERA.

2. Two-Phase Risk Assessment Approach

The updated guideline maintains its established stepwise assessment framework:

• Phase I: A screening evaluation based on predicted environmental concentrations to determine whether additional analysis is needed.

• Phase II: A comprehensive assessment that includes environmental fate studies, biodegradability evaluations, and chronic ecotoxicity testing.

Substances exceeding the 0.01 µg/L action limit, or those with endocrine, antibacterial, or antiparasitic activity, automatically progress to Phase II due to their higher ecological relevance.

3. Focus on PBT/vPvB Substances

The guideline strengthens evaluation criteria for substances classified as Persistent, Bioaccumulative, and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB).Manufacturers must proactively minimize environmental exposure to these compounds and outline risk-mitigation strategies within product labeling or the Summary of Product Characteristics (SmPC).

4. Alignment with Animal Welfare (3Rs Principle)

In support of EU animal-testing policies, the guideline emphasizes the Replacement, Reduction, and Refinement (3Rs) of animal studies.Applicants are encouraged to use validated alternative methods, share existing data, and avoid redundant studies to minimize animal use wherever possible.

5. Enhanced Transparency and Data Reuse

The updated ERA framework promotes data reuse and literature-based assessments. Applicants are encouraged to leverage existing scientific publications, Regulatory databases, and industry studies to prevent duplication, streamline evaluations, and reduce Regulatory delays.

Conclusion

At Freyr Solutions, our ERA specialists streamline the evolving ERA compliance process through end-to-end scientific and Regulatory support aligned with the EMA ERA Guideline 2024. Our services include literature review and data-gap analysis, PBT/vPvB assessments, customized strategies for sensitive compounds such as antibiotics and endocrine-active substances, preparation of data waivers and study summaries, ERA report development (CTD Module 1.6), and coordination of validated laboratory studies through accredited partners.

Supported by certified toxicologists and Regulatory experts, Freyr ensures seamless ERA compliance for both generic and new drug MAAs across EU markets. In a landscape where environmental responsibility is now a Regulatory imperative, early alignment with updated ERA requirements enables faster marketing authorization, reduced compliance risks, and stronger sustainability credentials.

By integrating robust ERA strategies, Freyr helps pharmaceutical companies achieve environmental compliance while advancing ecological responsibility and securing competitive advantage in the EU market.