Regulatory requirements for Dossier submission in African Countries (Kenya, Uganda, and Tanzania) - A Review

Abstract

Africa is world’s second fastest growing pharmaceutical market. The CGAR of African Pharmaceutical market is 10.6%. African people suffer from numerous diseases. The local pharmaceutical market is weak and insufficient to meet the demand of such diseased condition and so Africa relies heavily on externally developed and procured drugs. This combination of economic strength and prevalence of diseases is already driving a demand for medicines across Africa. The objective of this study is to delve in various parameters required for registration for externally developed pharmaceutical product African countries. A dossier containing detailed information about the drug and results of the studies carried out in its development process has to be submitted to the regulating bodies for getting market authorization. CTD is critical for dossier submissions. A comparative study will help the sponsor to file the dossier in many countries simultaneously; which can save time and money. Thus knowledge of guideline specific for individual country becomes important to determine the most stringent member, which shall ease approval process in other target countries in the region.