As of September 1, 2024, the European Medicines Agency (EMA) has implemented a new guideline (EMEA/CHMP/SWP/4447/00 Rev. 1- Corr.*) requiring all applicants for medicinal products, including generic medicines, to submit Environmental Risk Assessment (ERA) reports. The updated directive marks a significant shift in the regulatory landscape, reflecting the EMA’s commitment to minimizing the environmental impact of pharmaceuticals.

Previously, environmental risk assessments were only mandatory for new active substances, but the revised guideline now extends this requirement to generics. Although data sharing between companies is encouraged in the new guidelines, it is hard to expect that companies of originator product would provide letter of access for their ERA reports to applicants for generic products.

The EMA’s updated guideline introduces standardized procedures for evaluating risks to the environment, including detailed protocols for identifying and mitigating possible harm to water sources, soil, and wildlife. By including generic medicines, which make up a significant portion of the pharmaceutical market, the guideline aims to close previous regulatory gaps and address environmental concerns posed by the widespread use of these products. In a statement, the EMA emphasized the importance of this expansion, noting that the environmental safety of medicinal products is crucial for public health and sustainable ecosystems.

We at Billev Pharma East can offer you support in preparation of Environmental Risk Assessment reports for medicinal products, irrespective of their marketing authorisation type. Our team of experts have long time experiences with various topics of ERA and will guide you through successful preparation of ERA reports.