A Queuing Analysis of Medicines Registration System Performance in Ethiopian Food and Drug Authority
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Date
2023
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Addis Ababa University
Abstract
Background: The limited number of approved medicines and long waiting time for registration
are the major challenges limiting the performance of the regulatory system in Ethiopia. Queue
analysis is used for characterizing and estimating the queue process and operating variables of
the system to alleviate the challenges related to target timelines.
Objective: To assess the queuing performance of the registration system at the Ethiopian Food
and Drug Authority (EFDA).
Methods: A mixed sequential explanatory study design was used for the study. Quantitative
data collection involved a review of applications submitted to the EFDA from July 8, 2019 to
July 7, 2020. Basic operating characteristics of the registration system performance were
executed using single queue multiple server model of the queuing analysis. In-depth interviews
with purposively selected registration experts from the EFDA and private organizations were
done for the qualitative data collection. Analysis of the interviews involved the thematic analysis
approach.
Results: Mean arrival rate of applications to the registration system (λ=10.99 services per day)
was 23.74% higher than the mean effective service rate of the system (cμ=8.38 services/day).
Basic system performance average operating characteristics of the system could not be estimated
indicating that an infinite queue of applications built up over time and was hard to achieve any
target timeline in EFDA’s current registration system. The qualitative study also showed that the
system is being frequently challenged with backlogs.
Conclusion: The study documented weak system performance with lengthy registration process.
Appropriate measures to improve mean effective registration service rate should be introduced to
meet international standards and the agreed citizen’s charter of 2016.
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Keywords
Queue analysis, service rate, arrival rate, utilization factor, system performance characteristics.