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.
