ENVIRONMENTAL-RISK-ASSESSMENT-AS-A-SERVICE

Avoid potential environmental risks – and get the assessment you need to bring your medicinal product to the market.

Environmental Risk Assessment: Requirement to protect the environment

An Environmental Risk Assessment (ERA) is a mandatory requirement for all companies introducing human medicinal products (HMP) into the EU market. Its main purpose is to reinforce and ensure better protection of the environment and adequate precaution measures, if necessary.

Consequently, an ERA evaluates potential risks to the environment arising from the use of medicinal products in order to protect aquatic and terrestrial ecosystems, including surface water, groundwater, soil, and species at risk of secondary poisoning, and to assess the risk for microbial processes in sewage treatment plants.

Why conduct an ERA?

Regulatory Compliance:

An ERA is required for all new marketing authorization applications (MAA) for HMP or veterinary use submitted through a centralized, mutual recognition, decentralized, or national procedure.

Market Access:

Many markets mandate an ERA for product approval. If your pharmaceutical company fails to accurately present an ERA and risk mitigation measures, this may result in the denial of marketing authorization for the drug.

Furthermore, your products that have been on the market before 2005 will also require an ERA, if not already in place. As an applicant, you’re required to submit an ERA regardless of the legal basis, according to Directive 2001/83/EC.

Risk Management:

An ERA also helps to identify and mitigate potential environmental risks associated with your products. When the possibility of environmental risks cannot be excluded, you have to make specific arrangements to limit the environmental impact.

We take all three aspects into account when conducting an ERA. Our assessments are relevant and robust, performed by specialized environmental toxicologists based on the latest EU guideline, updated at the end of August 2024: EMEA/CHMP/SWP/4447/00 Rev. 1-Corr.

Environmental Risk Assessment: EMEA/CHMP/SWP/4447/00 Rev. 1-Corr. – what's new?

Generic medicinal products, hybrids, and similar biological applications are not exempt from submitting an ERA.

Applicants aren’t only required to submit an ERA for all initial MAAs and certain post-authorization applications (e.g. extension applications) regardless of legal basis: In addition, an ERA is also needed for applications under

  • Art 10(1)-generic medicinal products,
  • Art 10(3)-hybrid,
  • Art 10(4)-similar biological applications
  • Art 10a-well established use/bibliographical,
  • Art 10b-fixed combinations, and
  • Art 10c-informed consent applications.

The revised document includes new situations and considerations that reflect recent environmental challenges. Risk assessment and hazard assessment are always required:

1. Risk Assessment

The risk assessment reflects the possibility of an effect occurring. It is an evaluation of both exposure of organisms in the environment to the active substance, and ecotoxicity.

2. Hazard Assessment

The hazard assessment concerns the identification of intrinsic properties of an active substance that could render harmful to the environment regardless of the levels of exposure.

This sequential risk and hazard assessment consists of:

I:

Phase I:

In an initial screening phase, we identify the potential for bioaccumulation and persistence in the environment (PBT/vPvB assessment) and estimate in which form the environment is exposed to the substance by using the Predicted Environmental Concentration (PECsw).
IIA:

Phase II A:

If the PEC value exceeds the acceptable threshold, we analyze the fate and effects of the substance in the environment, including the consequences it might have on its organisms (for instance fish and daphnids in water) and calculate a definitive PBT/vPvB value. This allows us to make a preliminary risk evaluation.
IIB:

Phase II B:

If we have identified risks during the previous stage, we create a more detailed evaluation of the substance and an extended risk assessment.
RM

Risk mitigation:

Recommended safety measures, such as the appropriate labeling to instruct patients and health care professionals on the proper disposal after using your product.

Each report we provide is customized for your individual needs and handled confidentially. If environmental studies are necessary, we can perform them with qualified external partners.

For more Information

please contact our Senior Toxicologist Dr. Heidi Becker.
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