The testing approach for the Environmental Risk Assessment (ERA) of Pharmaceuticals


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Over the last decade, the need to assess the possible impact of chemicals to the environment has become an essential part of many safety programmes carried out on different substances. This is particularly important for chemical structures that can behave as Endocrine Disrupting Chemicals having a possible strong impact on environmental life in the three main compartments (water, soil and sediments).
Since December 2006, also certain active pharmaceutical ingredients can be subjected to the so called Environmental Risk Assessment (ERA) before being authorized for marketing in Europe.
When a medicinal product containing a given active principle may generate concern for the environment, hazards and possible risks are deeply evaluated by means of getting further information in relation to the extent of its intrinsic environmental hazard and its exposure of the environment. Specific investigation on the environmental fate and effects of the medicine on particular ecosystems is performed by means of a package of eco-toxicology and environmental fate studies as described in the EMEA guidance (EMEA/CHMP/SWP/447/00) (1). Further clarification ...