Introduction: A clinical trial is a research method used to provide evidence on the safety andrneffectiveness of interventions for specific medical conditions. In contrary to the disease burden,rnmost of the clinical trials were conducted in developed countries and the share of Africa as of 26rnJune, 2020accounts only around 2.98% of clinical trials done worldwide. Among the 10,249trialsrnconducted in Africa only 1.53% has been done in Ethiopia. Different factors have been identifiedrnas a barrier for trial development in Africa and challenges associated with Ethical and regulatoryrnsystem has been stated as the second most common barrier. The regulatory body is the one whornauthorizes and inspect clinical trials in Ethiopia. However, no study has been done so far on thernopportunities and challenges of clinical trial regulation which affect trial development. rnObjective: In this study the enablers and barriers of the regulatory system on clinical trialrndevelopment in Ethiopia is studied. rnMethod: In this descriptive qualitative study, a total of 15 participants, who had experience inrnconducting clinical trials in Ethiopia and staffs working in Ethiopian Food and DrugrnAuthority(EFDA) clinical trial team were identified from https://ClinicalTrials.gov,rnhttp://apps.who.int/trialsearch/default.aspx, from a data obtained from EFDA and by snowballrnsampling and involved in the study. Then data was analyzed in the thematic way of analysis. rnResult: The presence of a specific team within EFDA with a guideline, and staffs initiation tornregulate clinical trials are mentioned as an opportunity for clinical trial implementation. Differentrnbarriers such as lack of human resource and capacity, financial, infrastructure, regulatoryrnguideline and directives, and trial site follow-up inspection are stated as a bottleneck for thernresearchers to do clinical trial in Ethiopia. Moreover, not having a feedback for reports, notrntaking part in the trials closeout and unreasonably stringent regulatory system also mentioned asrna barrier. rnConclusion and recommendation: In Ethiopia, clinical trial researchers face substantial up andrndowns starting from clinical trial authorization to trial completion. We recommend that there is arnneed to strengthen the capacity of regulatory body and develop efficient system in order tornimprove clinical trials regulation in Ethiopia.