Guidelines for WHO pre-qualified medicines through collaborative registration procedure

Abstract

Marketing authorization (MA) of pharmaceutical products is one of the crucial regulatory requirements to ensure safety, quality and efficacy of medicines. The Ethiopian Food and Drug Authority has categorized finished pharmaceutical products (FPP) marketing authorization applications in to various product categories based on their risk level as per provision under the article 19 (1) of Proclamation No. 1112/2019. Various approval pathways are also devised to expedite the MA approval process.The same principle is also substantiated by the 2017 “Expediting Medicine Marketing Authorization Strategy”, which has set various initiatives to expedite the evaluation process of medicines registration applications.