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Publikationstyp
Wissenschaftlicher Artikel
Erscheinungsjahr
2023
Improving the regulatory environmental risk assessment of human pharmaceuticals: Required changes in the new legislation
Improving the regulatory environmental risk assessment of human pharmaceuticals: Required changes in the new legislation
Herausgeber
Quelle
Regulatory Toxicology and Pharmacology
142 (2023)
142 (2023)
Schlagwörter
Umweltrisikobewertung, Arzneimittelrecht, Ökotoxikologie, Wassergüte
Finanzierungskennzeichen
standardisiertes Finanzierungskennzeichen
Verbundene Publikation
Zitation
GILDEMEISTER, Daniela, Caroline T.A. MOERMOND und Cecilia BERG, 2023. Improving the regulatory environmental risk assessment of human pharmaceuticals: Required changes in the new legislation. Regulatory Toxicology and Pharmacology [online]. 2023. Bd. 142 (2023). DOI 10.60810/openumwelt-1511. Verfügbar unter: https://openumwelt.de/handle/123456789/1589
Zusammenfassung englisch
One of the flagship actions of the Pharmaceutical Strategy for Europe is to address environmental challenges associated with pharmaceutical use. This includes strengthening the Environmental Risk Assessment (ERA) at marketing authorisation (MA) of pharmaceuticals, and revision of the pharmaceutical legislation where needed. The overall aim of an ERA should be to enable comprehensive and effective identification and management of environmental risks of pharmaceuticals without affecting the availability of pharmaceuticals to patients. As experts in the evaluation of ERAs of human medicinal products submitted by pharmaceutical industries (Applicants), we have summarized the current status of the ERA and suggest legislative changes to improve environmental protection without affecting availability. Six regulatory goals were defined and discussed, including possible ways forward: 1) mandatory ERAs in accordance to the EMA guideline at the time of the MA, 2) enforcement of risk mitigation measures including re-evaluation of the ERA, 3) facilitated exchange of environmental data between pharmaceutical and environmental legislations, 4) substance-based assessments, 5) transparency of data, and 6) a catching-up procedure for active pharmaceutical ingredients that lack an ERA. These legislative proposals can be considered as prerequisites for a harmonised assessment and effective management of environmental risks and hazards of human pharmaceuticals. © 2023 The Authors.