Assessment of Factors Influencing Medicine Market Authorization Process in Ethiopia

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Addis Abeba University


Introduction: To provide safe, quality and effective medicine for the society, medicine has to be registered as per the regulatory requirement of a country. However, there is a reported delay in the market authorization process which has contributed to the shortage of life saving medicines. Therefore, studying those factors that influence medicine market authorization process will have an important role in addressing the problem in depth. Objective: The aim of this study was to assess the factors influencing medicine market authorization process in Ethiopia. Methods: A sequential, mixed method study using quantitative and qualitative methods was used. For the quantitative part, retrospective data on applications submitted through Medicine Registration Information System (MRIS) at Ethiopian Food Medicine Health Care Administration and Control Authority (EFMHACA) from July 1, 2016 to Dec 30, 2018 were collected. For the qualitative part, in-depth interviews were held with selected participants from EFMHACA, local representative of foreign pharmaceutical industries (LRFPIs) and local pharmaceutical industries (LPIs) about the challenges they face on the market authorization process. The collected quantitative data was entered to SPSS version 20 for analysis. Bivariate analysis was used to correlate the association between the dependent and independent variables. The qualitative data was analyzed using thematic analysis. Results: Among 317 new applications submitted through MRIS since 2016, only 18% were approved for Market Authorization (MA); whereas the majority of applications were still in process of registration. The identified factors that hinder MA approval were the limitation of resource, inadequate training and impracticality of regulation by applicants and EFMHACA. Conclusion and recommendations: MA process takes a long time due to impeding factors from EFMHACA, LRFPIs and LPIs sides. It is therefore recommended that EFMHACA install sufficient number of qualified personnel; whereas, for LRFPIs and LPIs, building the capacity of their staffs will improve the MA process.



Medicine Registration Information System, Market Authorization, Regulatory application.