These guidelines prescribe data, which is required to be submitted to the National Drug Authority to demonstrate the safety, efficacy and quality of vaccines being applied for market authorization. The guidelines also describe the format (CTD) in which dossiers should be presented in support of the application.
These guidelines provide a comprehensive framework aimed at addressing the dual burden of tuberculosis (TB) and HIV in the country. The guidelines emphasize the importance of integrated service delivery to improve health outcomes for individuals affected by both diseases.