Introduction: To provide safe, quality and effective medicine for the society, medicine rnhas to be registered as per the regulatory requirement of a country. However, there is arnreported delay in the market authorization process which has contributed to the shortage ofrnlife saving medicines. Therefore, studying those factors that influence medicine marketrnauthorization process will have an important role in addressing the problem in depth.rnObjective: The aim of this study was to assess the factors influencing medicine marketrnauthorization process in Ethiopia.rnMethods: A sequential, mixed method study using quantitative and qualitative methodsrnwas used. For the quantitative part, retrospective data on applications submitted throughrnMedicine Registration Information System (MRIS) at Ethiopian Food Medicine HealthrnCare Administration and Control Authority (EFMHACA) from July 1, 2016 to Dec 30,rn2018 were collected. For the qualitative part, in-depth interviews were held with selectedrnparticipants from EFMHACA, local representative of foreign pharmaceutical industriesrn(LRFPIs) and local pharmaceutical industries (LPIs) about the challenges they face on thernmarket authorization process. The collected quantitative data was entered to SPSS versionrn20 for analysis. Bivariate analysis was used to correlate the association between therndependent and independent variables. The qualitative data was analyzed using thematicrnanalysis.rnResults: Among 317 new applications submitted through MRIS since 2016, only 18%rnwere approved for Market Authorization (MA); whereas the majority of applications werernstill in process of registration. The identified factors that hinder MA approval were thernlimitation of resource, inadequate training and impracticality of regulation by applicantsrnand EFMHACA.rnConclusion and recommendations: MA process takes a long time due to impedingrnfactors from EFMHACA, LRFPIs and LPIs sides. rnIt is therefore recommended that EFMHACA install sufficient number of qualifiedrnpersonnel; whereas, for LRFPIs and LPIs, building the capacity of their staffs will improvernthe MA process.