,What is ERA?
An Environmental Risk Assessment (ERA) is the structured process of assessing potential harm to the environment from a chemical substance, or active pharmaceutical ingredient (API). For chemicals and pharmaceuticals, the ERA report is prepared based on the intended use of the product and the physico-chemical, ecotoxicological, and environmental-fate properties of its active substance(s). The assessment translates laboratory and monitoring data into practical conclusions about environmental exposure and hazard.
Why ERA matters
The EMA compliance now requires an Environmental Risk Assessment for marketing authorisation applications (MAAs) for human medicinal products — ERA findings inform labelling, Environmental hazard and risk mitigation and Module 1.6 of the eCTD dossier. Freyr helps you translate regulatory requirements into a robust, defensible ERA so your submission meets authority expectations while protecting aquatic and terrestrial ecosystems.
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Regulatory frameworks of ERA for Human Pharmaceuticals for Different Markets
Our ERA Services
Freyr provides pragmatic, regulatory-aligned ERA Compliance support for Environmental Risk Assessments (ERA) through the following specialized ERA Consulting services:
ERA Report Preparation (CTD Module 1.6)
Prepare an ERA report (for active substance and major metabolite) as part of CTD Module 1.6 of a MAA
PBT Assessment /vPvB Risk Assessment
PBT (Persistent, Bioaccumulative and Toxic)/vPvB (very Persistent and very Bioaccumulative) Assessment
Tailored Testing & Assessment Strategy
Tailored testing or specific assessment strategy for antibiotic, antiparasitic active substances or endocrine active substances (EASs)
Study Summaries & Documentation
Robust study summaries preparation for physico-chemical, environmental fate and ecotoxicological effect studies
Frequently Asked Questions (FAQs) on Environmental Risk Assessment (ERA)
We are here to provide you with the information you need quickly and efficiently.
01. What is an Environmental Risk Assessment (ERA)?
An ERA evaluates the potential environmental impact of medicinal or chemical products, assessing their effects on water, soil, air, and organisms after use or disposal.
02. Why is an ERA required for pharmaceuticals?
As per EU Directive 2001/83/EC and EMA’s 2024 guideline, an ERA is mandatory for new MAAs to ensure that human medicines do not cause unacceptable environmental risks.
03. At what stage is an ERA submitted?
ERA is included in Module 1.6 of the eCTD dossier for new MAAs and must be updated for variations or extensions that increase environmental exposure.
04. What substances are covered under ERA?
All pharmacologically active substances in a medicinal product require ERA evaluation, while excipients are generally exempted.
05. What are the main phases of an ERA?
ERA has two phases:
- Phase I – Screens potential environmental risk.
- Phase II – Conducts detailed fate, persistence, and ecotoxicity studies if risk is indicated.
06. What is a vPvB/PBT assessment?
It assesses if a substance is Persistent, Bioaccumulative, and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB), indicating long-term environmental risks.
07. Are ERAs required for generic medicines?
Yes. Generic MAAs must include an ERA unless valid ERA data from the reference product remain applicable and scientifically justified.
08. Can previously submitted ERA data be reused?
Yes, if data sharing agreements exist or applicants can justify that previous ERA conclusions remain valid under the 2024 EMA guideline.
09. What happens if an active substance poses a risk to the environment?
Risk mitigation measures are required, such as disposal instructions, environmental warnings in product labeling, or restrictions on product use.
10. How does Freyr support ERA compliance?
Freyr offers end-to-end ERA support—data gap analysis, PBT/vPvB assessments, CTD-ready summaries, tailored strategies for specific substances, and expert regulatory guidance.
11. What are the key guidelines referenced for ERA?
- EMA Guideline on ERA of Medicinal Products for Human Use (2024)
- REACH Regulation Annex XIII
- OECD Test Guidelines for fate and ecotoxicity.
12. What are the consequences of non-compliance with ERA requirements?
Incomplete ERA documentation can delay or jeopardize marketing authorization and lead to regulatory queries or requests for additional data.
