Regulatory aspects of vaccines [Aşılarda yasal düzenlemeler]

Abstract

in 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