EMA revises guideline on environmental risk assessment of human medicines

The updated European Medicines Agency (EMA) draft guideline on environmental risk assessment (ERA) now contains a decision tree which clarifies when ERA studies are required, and provides greater detail on technical guidance to help increase the consistency of the assessments. Performing an ERA is mandatory for any pharmaceutical company submitting a marketing authorisation application for a medicine.

The revision of the ERA guideline is based on a 2014 concept paper, and the work of a group of experts led by the Safety Working Party of EMA’s Committee for Medicinal Products for Human Use (CHMP). One of the major changes that has been introduces in the proposed revision is the introduction of the term ‘endocrine active substances’, to include all compounds that affect development or reproduction. Furthermore, guidance is given for the estimation of the exposure of predators to pharmaceuticals through the food chain, plus directly through the environment.

ERAs are designed to assess the possible effects of pharmaceuticals on the environment and ensure that adequate precautions are taken in case specific risks are identified. The ERA is based on the use of the product and the physico-chemical, ecotoxicological, and degradation and persistence of its active substance.

Some substances have shown direct effects on wildlife at or below the concentrations found in water and soil. For example, “male fish exposed to the main ingredient in the contraceptive pill may become feminised and this can affect the capacity of the population to reproduce”.

Stakeholders are invited to send their comments on the revised guideline by 30th June 2019.

To view the draft guideline on the ERA of medicinal products for human use, please click here.