The current EMA guideline for Environmental Risk Assessment
of Human Drugs is under review. While the scope of the testing under the new proposal will change, the reliance on current OECD guideline studies does not.
As the nature of pharmaceuticals change, with new chemical classes becoming mainstream, there is concern that the OECD studies developed for the evaluation of industrial chemicals might not provide the most suitable information for evaluating the environmental risk of modern-day pharmaceuticals.
Our Regulatory Affairs expert, Dr. Erick Nfon, describes the current and proposed European ERA test situation and discusses challenges that could affect a solid review based on the most appropriate science. Watch Dr. Nfon's brief overview
of his research presented at the 2020 SETAC Europe SciCon meeting, or download the full poster.
Have questions about the new guideline? Contact Dr. Nfon