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

CTA. Moermond, C. Berg, U. Bergstrom, L. Bielská, MG. Evandri, M. Franceschin, D. Gildemeister, MHMM. Montforts

. 2023 ; 143 (-) : 105443. [pub] 20230709

Language English Country Netherlands

Document type Journal Article

Persistent link   https://www.medvik.cz/link/bmc23016364

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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$a Proposal for regulatory risk mitigation measures for human pharmaceutical residues in the environment / $c CTA. Moermond, C. Berg, U. Bergstrom, L. Bielská, MG. Evandri, M. Franceschin, D. Gildemeister, MHMM. Montforts
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$a 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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$a Berg, Cecilia $u Swedish Medical Products Agency, P.O. Box 26, SE-751 03, Uppsala, Sweden. Electronic address: Cecilia.berg@lakemedelsverket.se
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$a Bergstrom, Ulrika $u Swedish Knowledge Centre of Pharmaceutical in the Environment, Swedish Medical Products Agency, Box 26, SE-751 03, Uppsala, Sweden. Electronic address: ulrika.bergstrom@sdslifescience.com
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$a Bielská, Lucie $u RECETOX, Faculty of Science, Masaryk University, Kotlarska 2, Brno, Czech Republic; State Institute for Drug Control, Šrobárova 48, 100 41, Prague, Czech Republic. Electronic address: Lucie.Bielska@sukl.cz
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$a Evandri, Maria Grazia $u Italian Medicines Agency, Via del Tritone 181, 00187, Rome, Italy. Electronic address: m.evandri@aifa.gov.it
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$a Franceschin, Marco $u Italian Medicines Agency, Via del Tritone 181, 00187, Rome, Italy. Electronic address: m.franceschin@aifa.gov.it
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$a Gildemeister, Daniela $u German Environment Agency (Umweltbundesamt), Wörlitzer Platz 1, 06846, Dessau-Roßlau, Germany. Electronic address: daniela.gildemeister@uba.de
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$a Montforts, Mark H M M $u Centre for Safety of Substances and Products, National Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA, Bilthoven, the Netherlands. Electronic address: Mark.montforts@rivm.nl
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