Introduction: There is growing concern that most of the developing worldâ€™s supply ofrnmedicines are of poor quality.Manufacturing facilities need to be compliant withrnregulatory requirement, which comprises a set of safeguards and procedures at each stagernof the production process to ensure that the manufactured product is of the desiredrnquality, safety and efficacy. rnThe aim of this study was to assess regulatory compliance of small-scale pharmaceuticalrnmanufacturing found in Addis Ababa city, Ethiopia. rnMethod: A cross-sectional observational and questionnaire based study was conducted tornassess regulatory compliance of small-scale local pharmaceutical manufacturingrncompanies and the major challenges faced by the manufacturing for implementation ofrnregulatory requirements. rnResult:Our study indicated that the overall implementation status of regulatoryrnrequirements in the local pharmaceutical manufacturing companies is far below thernminimum standard set by WHO and national regulatory Authority. From the totalrnregulatory element requirement only 26.1% were implemented by local small scalernpharmaceutical manufacturers. Major challenges faced by the local small scalernpharmaceutical manufacturing industry for the implementation of regulatory requirementrnwere: human resource capacity constraints, limited investment, Limited support fromrnGovernments and other stakeholders and poor Infrastructure. rnConclusion: The results of this study will help policy makers and regulatory bodies,rnpharmaceutical industries, and other stakeholders to design appropriate interventionalrnstrategy to improve the quality of products in the local pharmaceutical manufacturingrncompanies. rnRecommendation:Government and other stakeholders has a central role to play inrnnurturing the infant pharmaceutical industry through support supervision, facilitatingrnaccess to technology and business finance, and promoting market access at the national,rnregional and international levels.