Proposal for regulatory risk mitigation measures for human pharmaceutical residues in the environment

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Authors

MOERMOND Caroline T. A. BERG Cecilia BERGSTROM Ulrika BIELSKÁ Lucie EVANDRI Maria Grazia FRANCESCHIN Marco GILDEMEISTER Daniela MONTFORTS Mark H. M. M.

Year of publication 2023
Type Article in Periodical
Magazine / Source Regulatory Toxicology and Pharmacology
MU Faculty or unit

Faculty of Science

Citation
Web https://www.sciencedirect.com/science/article/pii/S0273230023001113?via%3Dihub
Doi http://dx.doi.org/10.1016/j.yrtph.2023.105443
Keywords Pharmaceuticals; Environment; Water quality; Risk mitigation; Authorisation
Attached files
Description Environmental risks of human pharmaceutical products should be made transparent and mitigated as far as possible. We propose to apply a risk mitigation scheme to the marketing authorisation of human medicinal products which is pragmatic and tailored, and thus will not increase the burden to regulators and industry too much. This scheme takes into account increasing knowledge and accuracy of the environmental risk estimates, applying preliminary risk mitigation when risks are determined based on model estimates, and definitive, more strict and far-reaching risk mitigation when risks are based on actual measured environmental concentrations. Risk mitigation measures should be designed to be effective, proportional, easy to implement, and in line with current (other) legislation, as well as not being a burden to the patient/health care professionals. Furthermore, individual risk mitigation measures are proposed for products showing environmental risks, while general risk mitigation measures can be applied to all products to reduce the overall burden of pharmaceuticals in the environment. In order to effectively mitigate risk, linking marketing authorisation legislation to environmental legislation is essential.
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