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Improving the regulatory environmental risk assessment of human pharmaceuticals: Required changes in the new legislation

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

. 2023 ; 142 (-) : 105437. [pub] 20230622

Jazyk angličtina Země Nizozemsko

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc23016684

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.

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$a Improving the regulatory environmental risk assessment of human pharmaceuticals: Required changes in the new legislation / $c D. Gildemeister, CTA. Moermond, C. Berg, U. Bergstrom, L. Bielská, MG. Evandri, M. Franceschin, B. Kolar, MHMM. Montforts, C. Vaculik
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$a 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.
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$a Moermond, Caroline T A $u Centre for Safety of Substances and Products, National Institute for Public Health and the Environment, the Netherlands. Electronic address: caroline.moermond@rivm.nl
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$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 $u RECETOX, Faculty of Science, Masaryk University, Kotlarska 2, Brno, Czech Republic; State Institute for Drug Control, Šrobárova 48, 100 41, Prague, Czech Republic. Electronic address: lucie.bielska@recetox.muni.cz
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$a Evandri, Maria Grazia $u Italian Medicines Agency, Rome, Italy. Electronic address: m.evandri@aifa.gov.it
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$a Franceschin, Marco $u Italian Medicines Agency, Rome, Italy. Electronic address: m.franceschin@aifa.gov.it
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$a Kolar, Boris $u National Laboratory of Health, Environment and Food, Prvomajska Ulica 1, 2000, Maribor, Slovenia. Electronic address: boris.kolar@nlzoh.si
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$a Montforts, Mark H M M $u Centre for Safety of Substances and Products, National Institute for Public Health and the Environment, the Netherlands
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$a Vaculik, Christine $u AGES - Austrian Agency for Health and Food Safety, Vienna, Austria. Electronic address: christine.vaculik@ages.at
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