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COMPARISON AND COMPILATION OF MARKETING AUTHORIZATION APPLICATION REQUIREMENTS FOR VACCINES....

Vaccines often contain compounds obtained from the bacterium, its surface proteins, or its toxins, all of which are obtained from a biological source. A thorough regulatory system is required before launching a new vaccination on the market to assess the vaccine's quality, efficacy, and safety. The registration of vaccine procedures in Saudi Arabia is done under the Saudi Food and Drug Administration's marketing authorisation (SFDA). Vaccine registration guidelines in Singapore are classified as therapeutic product registration. To register vaccines in Singapore, an NDA (New Drug Application) must be submitted.


The goal of this study was to gather information concerning registration procedures from Saudi Arabian and Singaporean rules, with the goal of determining how these standards may be reconciled. To ensure that vaccinations reach the worldwide population on time, a standardised registration system is essential.



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