Environmental Risk Assessment(ERA) [Europe Submission]

In the development and approval of human medicines, the focus is typically on ensuring the product is safe and effective for patients. However, there’s another critical dimension that cannot be ignored—the impact of pharmaceuticals on the environment. This is where the Environmental Risk Assessment (ERA) comes into play.  ERA is a regulatory requirement in many regions, including the European Union, and forms a crucial part of the marketing authorisation application (MAA) for any new medicinal product.

What is an Environmental Risk Assessment (ERA)?

An Environmental Risk Assessment evaluates the potential impact that a medicinal product may have on the environment when it is used, excreted, and ultimately disposed of. Specifically, the ERA looks at:

The fate of the active pharmaceutical ingredient (API) in various environmental compartments like water, soil, and sediment.

Toxic effects on organisms such as fish, algae, and aquatic invertebrates.

The potential for the compound to be persistent (P), bioaccumulative (B), and toxic (T), collectively referred to as PBT/vPvB substances.

The ERA is mandatory for all new MAAs submitted through centralized, mutual recognition, decentralized, or national procedures in the EU. It must be included in Module 1.6 of the Common Technical Document (CTD).

Why is ERA Important?

  1. Protecting Ecosystems
    2. Drugs can enter the environment through patient excretion, improper disposal, or Manufacturing waste. Without proper risk assessment, harmful residues could affect aquatic life, pollute drinking water, and disrupt ecosystems.
  1. Regulatory Compliance
    2. In the EU, submission of an ERA is legally mandated under Directive 2001/83/EC. An incomplete or inadequate ERA can delay or block market authorisation of your product.
  1. Sustainable Development
    2. Conducting an ERA ensures your pharmaceutical product aligns with global goals for environmental sustainability and responsible production, especially under the EU Green Deal framework.

When is an ERA Required?

An ERA is required for:
  • All new Marketing Authorisation Applications
  • Line extensions that may increase environmental exposure (e.g., new route of administration or expanded indications)
  • Type II variations, if they increase environmental impact

However, renewals of existing authorisations do not require a new ERA unless significant new data have emerged.

How is an ERA Conducted?

The ERA process is stepwise, consisting of Phase I and Phase II assessments:
  • Phase I: Initial Screening

This stage determines whether a full Phase II assessment is necessary. A predicted environmental concentration in surface water (PECsw) is calculated. If the PECsw is below 0.01 μg/L, no further testing is required, unless the substance is flagged for special concerns (e.g., antibiotics, endocrine disruptors).

  • Phase II: Detailed Assessment

If Phase I shows that a product may pose a risk, a more detailed investigation is carried out, involving:

  • Physicochemical properties: solubility, log Kow, degradation rate
  • Ecotoxicological studies: toxicity to fish, algae, and aquatic invertebrates
  • Environmental fate studies: adsorption to soil, biodegradability, potential for bioaccumulation
  • Risk mitigation strategies, if needed
  • Special Cases
  • Endocrine active substances (EAS) and antibacterials always require a tailored risk assessment, even if PECsw is low.
  • Biologic and peptide-based products may qualify for simplified justifications if they are shown to degrade rapidly or pose minimal risk.

What Must Be Included in an ERA Submission?

Your ERA report, as part of the MAA dossier, should include:

  • Identification of the active substance(s)
  • Results of PEC and PNEC (Predicted No Effect Concentration) calculations
  • Detailed study reports or scientific justifications
  • PBT/vPvB screening outcomes
  • Risk characterisation and, if applicable, risk mitigation measures
  • Data search and literature reviews (to follow 3Rs principles and reduce unnecessary animal testing)

The ERA should adhere to GLP standards and OECD test guidelines, and data must be sufficiently robust for scientific evaluation by regulatory authorities.

How Masuu Global Can Help You Navigate ERA : 

At Masuu Global Quality and Regulatory Consultants, we understand that the environmental assessment of pharmaceuticals is a complex, evolving area of regulation. Our team of experts can support you in:

  • Assessing ERA applicability and scope for your product
  • Designing and managing Phase I and Phase II ERA studies
  • Calculating PEC/PNEC ratios, log Kow, and environmental fate
  • Preparing full ERA reports aligned with EMA guidelines
  • Advising on data waivers or literature-based justifications
  • Interfacing with EMA or national competent authorities to resolve ERA queries or request scientific advice

We ensure your ERA submission is not only compliant but strategically optimized to support your product’s approval and sustainable lifecycle.

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