A Review of Generic Drug Registration Standards in Nigeria (KEY IJP************361)

• Naga Durga Bhavani.vaka

Abstract

This article offers a thorough analysis of the requirements to be taken into account while registering generic drugs in the Nigerian region, with a focus on Kenya, Ghana, and Botswana. Therefore, this article will eventually result in a greater understanding of the variations in dossier registration within different locations and will aid in the systematic adoption of necessary medications for more significant objectives in the near future. To prevent major surprises after applying, it is imperative that the regulatory approach for product development be set before developmental activity begins. The regulatory bodies have a vital responsibility to guarantee the efficacy, safety, and quality of any medications that are dispensed within their nation. Due to the lack of harmonization between the various regions, product registration in the rest of the world may also present difficulties. It comprises not just the procedure for manufacturing, distributing, and promoting pharmaceuticals in addition to controlling and overseeing their use.