Regulatory aspects of vaccines Aşılarda yasal düzenlemeler

ŞENEL S., Derici M. K., Devrim B.

Fabad Journal of Pharmaceutical Sciences, vol.45, no.2, pp.153-160, 2020 (Scopus) identifier

  • Publication Type: Article / Article
  • Volume: 45 Issue: 2
  • Publication Date: 2020
  • Journal Name: Fabad Journal of Pharmaceutical Sciences
  • Journal Indexes: Scopus, EMBASE, International Pharmaceutical Abstracts, TR DİZİN (ULAKBİM)
  • Page Numbers: pp.153-160
  • Keywords: European Medicines Agency (eMA), Food and Drug Administration (FDA), Marketing authorisation, Regulatory, Turkish Medicines and Medical Devices Agency (tMMDA), Vaccines, World Health Organization
  • Ankara University Affiliated: Yes

Abstract

© 2020 Society of Pharmaceutical Sciences of Ankara (FABAD). All rights reserved.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.