In November 2018, the EMA published a draft revision of EMEA/CHMP/SWP/4447/00 Rev. 1, the Guideline for Environmental Risk Assessment of Medicinal Products for Human Use. The new draft maintains the original guideline’s tiered structure of assessments but proposes numerous changes which stand to affect the conduct of future ERAs and subsequent submissions.
In preparation for the release of the final draft revision, Charles River’s team of scientists analyzed the ERAs for substances assessed between the guideline’s last publication date (2006) and the current day to determine the impact of proposed guideline changes on previously conducted studies. A summary of changes, as well as the results of our investigation, are included in this white paper.