The environmental risk assessment of human pharmaceuticals in the overall EU regulatory affairs process

The approval of new human pharmaceutical products in the EU requires an assessment of potential environmental risks related to the use by patients, besides the evaluation of the human safety, efficacy, and quality evaluation. The current guidance by the European Medicines Agency (EMEA), describing the process of the environmental risk assessment for human drugs, covers a two-tiered assessment programme with a modelling step for an environmental exposure scenario and a subsequent step of environmental fate and effects testing. The following paper describes ways how the requirements of the environmental risk assessment can be sensibly incorporated in the overall approval process of a pharmaceutical product including the risk/benefit analysis for the patient. The resources for environmental testing and assessment programmes can be employed economically, if the pharmacological, toxicological, and pharmacokinetic information obtained during the development programme of a human pharmaceutical is used to develop substance-specific test programmes and to evaluate the environmental risk assessment taking into account the pharmacodynamic properties and the use pattern by patients. Finally, we suggest that the environmental risk evaluation process as part of drug approvals should adhere to a focussed assessment strategy considering existing knowledge and the therapeutic needs.