Title : Saudi FDA guideline for chemistry, manufacturing, and control requirements of vaccines
Abstract:
Guideline for Chemistry, Manufacturing, and Control Requirements of Vaccines provides an overview of the regulatory, quality, and scientific requirements for the registration of vaccines. It describes expectations related to vaccine characterization, manufacturing, control, analytical testing, and stability, in alignment with SFDA, WHO, ICH, EMA, and FDA standards.
In addition to more general guidance, specific guidance is provided in the annexes, where vaccines have been classified in ten categories, i.e. live-attenuated, viral vector, inactivated, subunit, polysaccharide, virus-like particle, toxoid, outer membrane vesicle , DNA, and mRNA vaccines.
This guideline provides information for the marketing authorization applicants of vaccines to highlight considerations for regulatory approval of new vaccines for human use to ensure that all vaccines meet the highest possible quality standards. It covers a range of vaccine platform technologies, including traditional and modern platforms.
