Medicines registration process in Ethiopia: Its challenges and their impacts on the timely approval and procurement of essential medicines in the country

Abstract

: Although the provision of safe, effective, quality, and affordable essential medicines and supplies is one of the elements of health for all indicators set by world health organization (WHO), one third of the world’s population lacks reliable access to required medicines and the situation is even worse in developing countries. Among the various factors that can be attributed to this poor access to medicines in the developing countries are the regulatory processes required to bring the medicines to the market and patients that require significant human, financial, and material resources from national medicines regulatory authorities (NMRAs) as well as considerable information from applicants. Objective: This study was conducted to identify the challenges of the medicines registration process (MRP) in Ethiopia and assess their impacts on the timely approval and procurement of essential medicines in the country. Methods: A descriptive, cross-sectional, questionnaire-based study was conducted from July 19,2017 to September 25,2017 to collect information from the dossier evaluators, good manufacturing practice(GMP) inspectors, quality control laboratory(QCL) analysts, technical persons of local and multi-national pharmaceutical industries(TPLMNPIs), local agents of foreign pharmaceutical industries (LAFPIs), and pharmaceutical fund and supply agency procurement officers(PFSAPOs) about the challenges they face while performing their respective activities all aimed to facilitate the availability of safe, effective, and quality medicines for human use in Ethiopia. A retrospective review of the medicines registration applications (MRAs) submitted to Ethiopian food, Medicines and health care administration and control authority (EFMHACA) from 11 April 2014 to 05 September 2017 was also done to assess the impacts of these challenges on the timely approval and procurement of essential medicines in Ethiopia. Results: This study found shortage of qualified personnel at the EFMHACA and poor quality of the submitted MR dossiers as the two major challenges facing the EFMHACA in carrying out its MR activities. These challenges with other multifaceted challenges facing the EFMHACA and the applicant pharmaceutical industries(PIs) and/ or their local representatives, are significantly delaying the MRP in Ethiopia as it was found that only 17(1.8%) of MRAs approved by the EMHACA were completed within the expected time. Conclusion and Recommendations: The various challenges facing the EFMHACA and the applicant PIs and/ or their local representatives are delaying the MRP decreasing the availability of alternative registered medicines in the country. So, all stakeholders directly and/or indirectly involved in MR in Ethiopia should work their best to solve these challenges and improve the availability of medicines in the country.