Ecopharmacovigilance: A Comparative Regulatory Framework in The Us and Eu
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Author:
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MS.PALLAVI MN, DR.GANESH GNK, MR.VIGNESH M
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Abstract:
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Pharmaceutical products are believed to enhance the safety of living to cure or prevent diseases. This Pharmaceutical products, however it can cause serious disruptive impacts on living organisms, when they are dispersed throughout the environment by a different path. In the past few years, the difficult tasks for the pharmaceutical industries is adapting to the effect of pharmaceutical products on earth. Such natural wellbeing and protection issues made ready in building up a rightful regulatory regime for Environment Risk Assessment (ERA) of pharmaceutical products .The majority of regulatory improvements have been made in ERA for pharmaceutical products in developed countries such as the US, EU, Canada. Countries around the world and organizations such as OECD have developed procedures for ERA to achieve the main goal. Currently, there is an absence of specified guidance for ERA of pharmaceutical products in other countries around the world. However, in the future, they are supposed to have stringent guidelines and legislative specifications. This study seeks to acknowledge, compare, and contrast ERA embraced by developed countries such as Europe and the US. In this study, we have given an outline of the awareness of pharmaceuticals products on ERA and its environmental impacts. Hence, it is important to develop an Eco Pharmaco-Vigilance (EPV) framework for monitoring and collecting information, which will eliminate the possibility of medicinal products that reach the earth. Within this review article we compared about the ERA that developed countries like Europe and the US have adopted.
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Keyword:
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Eco pharmaco-vigilance, Environmental impacts, Comparison, Guidelines, ERA.
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EOI:
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DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.022
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