Improving the regulatory environmental risk assessment of human pharmaceuticals: Required changes in the new legislation
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14310%2F23%3A00133523" target="_blank" >RIV/00216224:14310/23:00133523 - isvavai.cz</a>
Result on the web
<a href="https://www.sciencedirect.com/science/article/pii/S0273230023001058" target="_blank" >https://www.sciencedirect.com/science/article/pii/S0273230023001058</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.yrtph.2023.105437" target="_blank" >10.1016/j.yrtph.2023.105437</a>
Alternative languages
Result language
angličtina
Original language name
Improving the regulatory environmental risk assessment of human pharmaceuticals: Required changes in the new legislation
Original language description
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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
10511 - Environmental sciences (social aspects to be 5.7)
Result continuities
Project
<a href="/en/project/EF17_043%2F0009632" target="_blank" >EF17_043/0009632: CETOCOEN Excellence</a><br>
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Regulatory Toxicology and Pharmacology
ISSN
0273-2300
e-ISSN
1096-0295
Volume of the periodical
142
Issue of the periodical within the volume
August 2023
Country of publishing house
US - UNITED STATES
Number of pages
8
Pages from-to
1-8
UT code for WoS article
001144442200001
EID of the result in the Scopus database
2-s2.0-85163436542