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Roadmap of European Union Pharmacovigilance Requirements on European Medicines Agency
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| Author:
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KRISHNA K, DR RAJU KAMARAJ
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| Abstract:
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This article gives a summary of the European Union Pharmacovigilance system journey. Pharmacovigilance
originated about 170 years ago, but at the time it was not yet called as such. Here we present the
pharmacovigilance milestones until present day, for the purpose to describe all the steps of history; from the
initial findings, which simply lists clinician’s warnings to publishers of major journals to the current and highly
organized electronic registries of today. The historic steps help peoples to learn how pharmacovigilance has
helped us to obtain such important public health outcomes and for pharmacology itself. The system’s
fundamental goal is to empower and secure patient health by encouraging the accessibility of drugs which
include already unsatisfied patient needs, and by minimising the risk of side effects. The Pharmacovigilance
framework of the European Union is now totally established into the pharmaceutical product life cycle, with
pharmacovigilance preparation starting before a drug is introduced, and companies are encouraged to start
planning high innovation products quite early. Pharmaceutical safety data are often gathered after permission
from a number of outlets, including accidental reports of side effects or verification of existing evidence in the
world. Ultimately, the Pharmacovigilance function review, auditing and inspection and building
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| Keyword:
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European Medicines Agency, Pharmacovigilance Risk Assessment Committee, National Competent Authorities, Pharmacovigilance, Marketing Authorisation Holders.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.342
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| Download:
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Request For Article
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