Regulatory Aspects of Vaccines
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Tarih
2020
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Erişim Hakkı
info:eu-repo/semantics/openAccess
Özet
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.
Açıklama
Anahtar Kelimeler
Halk ve Çevre Sağlığı, Sağlık Politikaları ve Hizmetleri
Kaynak
FABAD Journal of Pharmaceutical Sciences
WoS Q Değeri
Scopus Q Değeri
Cilt
45
Sayı
2