Regulatory aspects of vaccines [Aşılarda yasal düzenlemeler]

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dc.contributor.authorŞenel S.
dc.contributor.authorDerici M.K.
dc.contributor.authorDevrim B.
dc.date.accessioned2021-01-14T18:11:24Z
dc.date.available2021-01-14T18:11:24Z
dc.date.issued2020
dc.departmentKKÜ
dc.description.abstractin order to get a marketing authorisation, a vaccine product must fullfill the national/international requriements for efficiency, safety and quality. Due to its complex structure, the manufacture, control and regulation of a vaccine requires special expertise and procedures when compared to that of a small molecule drug. in this paper, the registration procedures of vaccines in different countries including Turkey, european Union, UsA and the countries covered by the world Health Organization (wHO) will be reviewed and the regulatory requirements and related guidelines are summarised. © 2020 Society of Pharmaceutical Sciences of Ankara (FABAD). All rights reserved.en_US
dc.identifier.endpage160en_US
dc.identifier.issn1300-4182
dc.identifier.issue2en_US
dc.identifier.scopus2-s2.0-85096053213
dc.identifier.scopusqualityQ4
dc.identifier.startpage153en_US
dc.identifier.urihttps://hdl.handle.net/20.500.12587/12975
dc.identifier.volume45en_US
dc.indekslendigikaynakScopus
dc.language.isoen
dc.publisherSociety of Pharmaceutical Sciences of Ankara (FABAD)en_US
dc.relation.ispartofFabad Journal of Pharmaceutical Sciences
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectEuropean Medicines Agency (eMA)en_US
dc.subjectFood and Drug Administration (FDA)en_US
dc.subjectMarketing authorisationen_US
dc.subjectRegulatoryen_US
dc.subjectTurkish Medicines and Medical Devices Agency (tMMDA)en_US
dc.subjectVaccinesen_US
dc.subjectWorld Health Organizationen_US
dc.titleRegulatory aspects of vaccines [Aşılarda yasal düzenlemeler]en_US
dc.typeArticle

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