Environmental Risk Assessment of Pharmaceuticals in the EU — A Regulatory Perspective

Abstract

The authors report on the progress made in the development of regulatory guidance documents on environmental risk assessment (ERA) procedures of human as well as veterinary medicinal products. The elaboration of an EU Note for Guidance (NfG) document on the ERA of human pharmaceuticals began more than a decade ago. Seven years have passed since a multi-lateral process has been initiated aiming at the development of a new guidance paper on the ERA of veterinary medicinal products. At present, both documents are still in a draft stage but have been released for a six-month public consultation period (human pharmaceuticals: July 2003-January 2004; veterinary pharmaceuticals: October 2003-April 2004). Both guidance documents are expected to be implemented with changes possible in the EU in 2004/05.