30 November 2018 - EMA has published a PDF revision of its guideline on the environmental risk assessment of human medicines for a six-month public consultation. 

Stakeholders are invited to send their comments by 30 June 2019 to era_dg@ema.europa.eu using the Microsoft Office document template provided.

The presence of biologically-active pharmaceuticals in the environment is a growing concern, because some of these 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. Pharmaceuticals may also have indirect effects e.g. a recent study shows that pharmaceutical compounds detected in surface waters can transfer from invertebrate larvae to the predators that feed on them.

Read EMA press release