Environmental risk assessment (ERA) plays a crucial role in evaluating the potential impact of medical products on the environment.
Both the EMA and FDA emphasize the need to assess the environmental risks associated with drug use, considering the discharge of drugs into sewage systems and their entry into various ecosystems. The EMA's guidelines provide more detailed instructions for conducting robust ERA studies, while the FDA's approach is simpler but more comprehensive in terms of reporting recommendations. The revision of the EMA guideline highlights the requirement for ERA reports even for generic medicinal products. The assessments by both the EMA and FDA involve estimating the substance concentration in aquatic environments, and if necessary, conducting further tests to evaluate toxicity.
This article compares the guidelines provided by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) regarding ERA requirements for marketing approval of human medicines.