Regulatory aspects of vaccines Aşılarda yasal düzenlemeler

ŞENEL S., Derici M. K., Devrim B.

Fabad Journal of Pharmaceutical Sciences, cilt.45, sa.2, ss.153-160, 2020 (Scopus, TRDizin) identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 45 Sayı: 2
  • Basım Tarihi: 2020
  • Dergi Adı: Fabad Journal of Pharmaceutical Sciences
  • Derginin Tarandığı İndeksler: Scopus, EMBASE, International Pharmaceutical Abstracts, TR DİZİN (ULAKBİM)
  • Sayfa Sayıları: ss.153-160
  • Anahtar Kelimeler: European Medicines Agency (eMA), Food and Drug Administration (FDA), Marketing authorisation, Regulatory, Turkish Medicines and Medical Devices Agency (tMMDA), Vaccines, World Health Organization
  • Ankara Üniversitesi Adresli: Evet

Özet

© 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.