ERAs are a mandatory component of the marketing authorization dossier for human medicinal products in the European Union. The purpose of an ERA is to assess the potential environmental impact of medicinal product residues and, where necessary, to define measures for risk mitigation.
Pharmaceutical active substances can enter the environment after use — for example, through excretion, improper disposal, or manufacturing residues. Some substances are persistent, bioaccumulative, or toxic, and may have long-term effects on ecosystems. ERAs help to identify and manage these risks at an early stage. At the same time, they are a prerequisite for the approval of a new medicinal product and also play a role in variations or updates to existing marketing authorizations.
With the planned reform of European pharmaceutical legislation, environmental assessment is gaining even greater importance. One of the main objectives of the reform package is to improve the environmental sustainability of medicinal products. In the future, sustainability aspects and environmental risks are expected to be more strongly integrated into the benefit-risk assessment of medicinal products. Additionally, existing ERA data will need to be reviewed regularly and updated in light of new scientific evidence. This makes the ERA a dynamic instrument for both environmental and patient protection.
Diapharm supports pharmaceutical companies in planning, preparing, and updating Environmental Risk Assessments as part of marketing authorization procedures or lifecycle activities. This includes strategic evaluation of existing data, commissioning and oversight of laboratory studies, and preparation of the required dossier modules. Our experts ensure that all documentation meets current regulatory requirements and is efficiently integrated into the authorization process.
