Environmental risk assessment of human pharmaceuticals in the European Union: A review of the estimation of environmental exposure

August 10, 2017

There has been a marked increase in the last few years in concern regarding the fate and effect of pharmaceuticals in the environment following the detection of pharmaceuticals in sewage treatment plant (STP) effluents, surface waters, groundwater and even drinking water.

The current regulation of pharmaceuticals requires an environmental risk assessment as part of a marketing authorisation application in the EU and a new drug application in the US. Guidance issued by the European Medicines Agency (EMA) and the US Food and Drugs Agency (USFDA) describes how the pharmaceutical active substances should be assessed for possible adverse effects in the environment. In both regimes a simple approach is recommended to estimate the exposure concentration. These estimation methods generally average the exposure concentration in the environment that is treated as a homogenous entity. 

For pharmaceuticals and personal care products (PCP) that enter the environment exclusively from human use, spatially explicit models that take into account the specific characteristics of the drainage basin are more relevant. This poster presents two spatially explicit models that could would provide a basis for developing a proper strategy of the environmental risk assessment of human pharmaceuticals.
Click here to download a copy of the report.

To discuss this topic further, contact:
Dr. Erick Nfon
erick.nfon@smithers.com
+44 (0) 1423 532 710

200

About The Author | Dr. Erick Nfon

Dr. Erick Nfon is a Regulatory Scientist with particular experience in environmental fate modeling and regulatory affairs. Erick has spent 14 years working in Academia, Industry and at European Contract Research Organisations and regulatory consultancies. His responsibilities include environmental risk assessments, dossier preparation and submission, and the provision of scientific expertise and advice to support registration programmes for plant protection products, biocides, pharmaceuticals, and general industrial chemicals.

More by Author