Background: Medical products are regulated from premarket clinical trials to post marketingrnsurveillance and phase IV clinical trials. Research organizations have responsibilities to conductrnclinical trials subject to regulatory and national ethics review process before putting products onrnthe market. Harmonized approaches for regulation of clinical trials and national ethics review arernpracticed globally including in Eastern Africa countries under regional economic communities.rnHowever, there are gaps in medicine regulatory in general and clinical trials regulatory andrnnational ethics review harmonization in particular. Objective: The aim of this study was tornassess the need and readiness for implementation of harmonized clinical trial regulation andrnnational ethics review in Eastern Africa.rnMethodology: A qualitative study was conducted in selected Eastern Africa countries focusingrnon regional economic communities (RECs). Data were collected through semi structuredrnquestionnaire from National Regulatory Authorities, National Ethics Review Committee,rndevelopment partners, sponsor and research institutions through email by assigning facilitators inrneach country, and were analyzed thematically using QDA Miner Lite qualitative data analysisrnsoftware. Specific countries regulatory and ethics review system components were analyzedrnaccording to the nature of questions and responses.rnResults: It was noted that 5 Eastern Africa countries involved (Ethiopia, Kenya, Sudan, Ugandarnand Tanzania) in the present study had national legislations for medicines and clinical trialsrnregulations. Shortage, lack of experience, lack of appropriate expertise and poor professional mixrnwere staff related problems identified in this study. It was noted that clinical trial structures werernestablished at directorate level in one country, at team level in three countries and none in one.rnThese findings reflect countries readiness for implementation of harmonization initiative.rnCapacity building, utilizing limited resources in the region and ensuring quality were some ofrnneed related findings for implementation of harmonized approach. Existence of platforms likernRECs, partners support and enabling conditions were identified opportunities for implementationrnof harmonized regulation and national ethics review. Challenges identified were lack ofrnawareness, difference in administrative procedures, lack of commitment, resource limitation, andrnrequiring long time for implementation of harmonization. Differences were also noted amongrncountries and RECs (IGAD and EAC) in regulatory system and progress in implementation ofrnharmonization initiative respectively.rnConclusion: The readiness of most of the countries in regulating clinical trials is not adequate tornimplement harmonized clinical trials regulation and national ethics review. However, there isrnremarkable need for harmonization in the region. Countries need to strengthen their clinical trialrnregulatory and national ethics review system in consideration of harmonization.