Paul Kuiken is Vice President Transformation Services Practice, G&L Scientific, UK. He has extensive regulatory project skills, developed over 30 years in the pharmaceutical industry and through a number of significant roles at Pharmalink Consulting, Genpact, VCLS, BlueReg, and now with G&L.
The profound impact of pharmaceuticals on the environment has been acknowledged for decades. In the EU, two key mechanisms that assess this risk are the Environmental Risk Assessment (ERA), and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). As both frameworks are under assessment, this article looks at the key considerations within the ERA.
The body of research being published which is focused on the environmental impact of pharmaceuticals is increasing rapidly. It highlights a growing concern among the public for medicinal products accumulating in the natural world through a variety of originating sources.