Abstract

Background: Medicines are essential part of any healthcare system. Limited access to medicines undermine in healthcare systems. Ethiopian Food, Medicine and Healthcare Administration and Control Authority had been mandated to ensure quality, safety and efficacy of medicines nonetheless medicines registration process contributes to the availability of quality and safe medicine in Ethiopia. 80% of medicines used in Ethiopia were imported from abroad; in this regard, medicines registration process should be effective and avoid unnecessary delays in Ethiopia.

Objective: The main aim of this study was to explore the challenges of medicines registration process in Ethiopia. Methods: Qualitative phenomenological study design was employed. Purposive sampling technique was used to select study participants until saturation point of themes reached. Key informant interviews and focus group discussion were used to collect data using unstructured questionnaires. The data were analyzed by thematic content analysis technique.

Results: In the present study different challenges were identified and explored; among these challenges: limitation on Ethiopian medicine registration guideline; inadequate human resources and prolonged medicine registration process. Hence, it results delayed the medicine registration process. Another challenge were dossier related challenges such as most local manufactures and medicines importers were lack of skilled about common technical documents required for medicine dossier submission and which is the most challenge identified for medicine registration process in Ethiopia.

Conclusion: In this study various challenges for medicine registration process were identified and explored. Hence, the Ethiopia Food, Medicine and Healthcare Administration and Control Authority should developed strategy for effective medicine registration process.

Keywords: Challenges; EFMHACA; Guideline; Medicines registration