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    Regulatory Aspects of Vaccines
    (2020) Şenel, Sevda; Derici, Mehmet Kürşat; Devrim, Burcu
    In order to get a marketing authorisation, a vaccine product mustfullfill 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 andprocedures when compared to that of a small molecule drug. Inthis paper, the registration procedures of vaccines in differentcountries including Turkey, European Union, USA and thecountries covered by the World Health Organization (WHO)will be reviewed and the regulatory requirements and relatedguidelines are summarised.