COMPARISON AND COMPILATION OF MARKETING AUTHORIZATION APPLICATION REQUIREMENTS FOR VACCINES IN SAUDI ARABIA AND SINGAPORE

Vaccines contain agents which are often made from the microbe or its surface proteins or its toxins, which are eventually derived from the biological source. Before launching a new vaccine in the market, the rigorous regulatory procedure is required to assess the quality, efficacy and safety of the vaccine. Saudi Arabia registration of vaccine procedure is done under the marketing authorization of Saudi Food and Drug Administration (SFDA). Registration of vaccines guidelines in Singapore is categorized under Therapeutic product registration. NDA (New Drug Application) application must be filed for registering the vaccines in Singapore.

This study was aimed to bring out information about the registration procedures amongst the guidelines from Saudi Arabia and Singapore and concluding from the fact that how these guidelines can be harmonized. The harmonized registration procedure is required to ensure the reachability of the vaccines on time to the global population.