A Retrospective Review of Pharmaceutical Product Dossiers Submitted at the Pharmacy and Poisons Board Between 2010 and 2014

Abstract

Background: Efficient regulation of pharmaceutical products is crucial in ensuring that the medicines within a specified territory meet the stipulated standards of quality, safety and efficacy. The national medicine regulatory authority (MRA) is responsible for drug regulation by ensuring that the products marketed are of the right quality before issuing a marketing authorization, also known as registration certificate or product license. The process of drug registration requires submission of a dossier to the MRA, in Common Technical Dossier (CTD) format which essentially contains all administrative, quality, clinical and non-clinical information about the product. This information has to comply with set WHO guidelines and territory-specific guidelines prior to issuance of a registration certificate. This study is a retrospective review of dossiers submitted at the Pharmacy and Poisons Board, the drug regulatory authority in Kenya, from the period starting January 2014 and ending December 2014. Objective: The purpose of this study was to carry out a retrospective review of pharmaceutical product dossiers submitted to the Pharmacy and Poisons in the period starting January 2010 and ending December 2014. Specifically, the study evaluated the turnaround time for new drug approvals and the factors influencing the timelines for drug registration. The study also looked into the therapeutic categories of the pharmaceutical products whose dossiers were submitted in the specified period. A comparative study of Kenya’s processes with its neighboring countries, Uganda and Tanzania was also done..................