New EMA guideline: environmental risk assessment of pharmaceuticals

On March 21, 2024, the EMA released the new guideline for the Environmental Risk Assessment (ERA) of pharmaceuticals intended for human use.

The guideline outlines how to conduct an Environmental Risk Assessment (ERA) and evaluate potential environmental risks associated with the use of pharmaceuticals, aiming to protect aquatic and terrestrial ecosystems.

The new guideline will take effect on September 1, 2024, introducing new provisions to ensure a comprehensive and accurate assessment of the environmental impact potential of pharmaceuticals.

One key aspect of this new guideline is the introduction of a package of studies comprising physicochemical characterization, environmental fate, and ecotoxicology, in accordance with Good Laboratory Practices (GLP) for molecules requiring in-depth evaluation (Phase II).

The guideline also includes consideration of potential precautionary and risk reduction measures and provides guidance on reporting results in an environmental risk assessment report.

Our team of experts is ready to assist you in interpreting and meeting the requirements of the new guideline. Feel free to contact us for more information on the GLP study package that meets the criteria set by the EMA.

Further informations:
info@labanalysis.it