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.
| Translated title of the contribution | Aşılarda yasal düzenlemeler |
|---|---|
| Original language | English |
| Pages (from-to) | 153-160 |
| Number of pages | 8 |
| Journal | Fabad Journal of Pharmaceutical Sciences |
| Volume | 45 |
| Issue number | 2 |
| Publication status | Published - 2020 |
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
Keywords
- European Medicines Agency (eMA)
- Food and Drug Administration (FDA)
- Marketing authorisation
- Regulatory
- Turkish Medicines and Medical Devices Agency (tMMDA)
- Vaccines
- World Health Organization
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