Assessment of Factors Influencing Medicine Market Authorization Process in Ethiopia
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Date
2020-06
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Addis Abeba University
Abstract
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.
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Keywords
Medicine Registration Information System, Market Authorization, Regulatory application.