Environmental Risk Assessment for Medicinal Products for Human Use

The European Medicines Agency’s (EMA) Environmental Risk Assessment (ERA) guidelines are set to come into effect on September 1, 2024.

This EMA Environmental Risk Assessment guideline is crucial for everyone involved in the pharmaceutical industry, as it outlines the mandatory requirements for including an ERA in marketing authorisation applications for medicinal products. Understanding and adhering to these guidelines is essential to ensure compliance and to mitigate potential environmental impacts.

ERA is a fundamental process in the pharmaceutical industry involving a series of studies and scientific testing aimed to identify and quantify the potential adverse effects that drugs may have on aquatic and terrestrial environments. These studies include toxicological tests, biodegradability studies, drug metabolism analysis, and risk assessment of their presence in different environmental compartments.

The new guideline from the European Medicines Agency (EMA), accepted on February 15 and set to come into effect on September 1, 2024, specifies that an ERA report will be required for all new applications for marketing authorisation of medicinal products for human use to assess the potential risks to the environment arising from the use, storage and disposal of a human medicinal product.  It applies to various types of applications, ensuring that all medicinal products undergo thorough environmental scrutiny.

When should ERA be updated?

• New indications such as in an increase in the extent of the use or extension applications of a medicinal product.
• New data availability after post-authorisation phase.

The ERA is a multidisciplinary assessment based on several critical factors:

• Product Usage: This considers how the medicinal product will be used in real-world settings.
• Physico-chemical Properties: These are the inherent characteristics of the active substances, such as solubility and stability.
• Ecotoxicological Properties: This involves understanding the potential ecological impacts of the substance, including toxicity to aquatic and terrestrial organisms.
• Fate Properties: This examines how the substance behaves in the environment, including its persistence, bioaccumulation, and potential for degradation.

These components collectively help in assessing the potential risks a medicinal product might pose to the environment.

The ERA must be included in Module 1.6 of the CTD dossier. This ensures that the environmental impact assessment is integrated into the regulatory submission process, providing a clear and structured approach for regulatory reviewers.

For each ERA, both a risk assessment and a hazard assessment are required.

In Phase I the potential for environmental exposure is assessed based on the nature of the active substance and the intended use of the medicinal product.

The products that require a more extensive Phase II risk assessment are identified based on their use and/or environmental exposure. The new decision tree included in this section is used to determine if the risk assessment stops at Phase I or continues to Phase II. The basis for a decision not to proceed to Phase II should be included in the ERA report.

The following should be considered in Phase II of the risk assessment:

• Determination of physio-chemical properties, fate and ecotoxicity
• Trigger values for soil, groundwater and secondary poisoning
• Surface water
• Sediment
• Sewage Treatment Plant
• Soil
• Groundwater
• Secondary Poisoning
• Tailored testing strategy for active substances with a specific mode of action
• Antibacterials
• Endocrine active substances (EAS)

Understanding and adhering to these requirements is essential to ensure compliance and to mitigate potential environmental impacts.

As experts in the evaluation of ERAs of human medicinal products we can help you with the following services:

• Gap analysis Phase I and Phase II
• Testing strategy Phase I and Phase II
• Risk Assessment Phase I and Phase II
• Final interpretation and mitigation actions

We can assist you with all your regulatory and testing needs, ensuring your submissions are thorough, accurate, and compliant with the latest guidelines.

Contact us today to overcome your current and future challenges, by ensuring the safety of your drugs within an overall environmental responsibility!