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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Roadmap of European Union Pharmacovigilance Requirements on European Medicines Agency

Author: KRISHNA K, DR RAJU KAMARAJ
Abstract: 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
Keyword: European Medicines Agency, Pharmacovigilance Risk Assessment Committee, National Competent Authorities, Pharmacovigilance, Marketing Authorisation Holders.
DOI: https://doi.org/10.31838/ijpr/2021.13.02.342
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