Rashed Edris Usure ¹ Yesuneh Tefera Mekasha ^2* Dereje Kebebe ³ Gemmechu Hasen ⁴ Firdos Hafiz ⁵ Sileshi Dubale ⁶ Sultan Suleman ³

• ¹ School of Pharmacy, Hawassa University, Hawassa, Southern Nations, Nationalities, and Peoples' Region, Ethiopia
• ² Pharmaceutical Sciences, Pharmaceutical Quality Assurance and Regulatory Affairs, University of Gondar; P.O.BOX:196, Gondar, Ethiopia,, Gondar, Ethiopia
• ³ Institute of Health, Jimma University, Jimma, Oromia Region, Ethiopia
• ⁴ Armauer Hansen Research Institute (AHRI), Addis Ababa, Addis Ababa, Ethiopia
• ⁵ Medicine Registration and Licensing, Ethiopian Food and Drug Administration, Addis Ababa, Ethiopia, Addis Ababa, Ethiopia
• ⁶ Department of Pharmacy, College of Health Sciences, Mettu university, Mettu, Ethiopia

The World Health Organization (WHO) reports that a significant portion of the global population relies on traditional herbal medicine (THM) due to limited access to safe and high-quality modern medical care. The archival review of the study found that Ethiopia's THM legislative and regulatory framework is still in a developmental phase, particularly when compared with countries that have more established systems. A cross-sectional study indicated that approximately 79.7% of participants were aware of THM-related content in the current legislation. However, about 82.3% reported they had not received any formal training on THM regulations. For future roadmaps, around 73.8% of respondents believed the government showed a commitment to supporting THM regulation, though about 51.9% of participants noted limited knowledge and awareness of THM practices and product regulations. In terms of quality, safety, efficacy, rational use, and storage conditions, 49.8% of respondents rated regulatory implementation practice as not satisfactory. In this study, the majority of study participants raised concerns about the performance of quality control parameters. Among regulatory experts, weak performance was identified in the practical implementation of THM regulatory activities, with 70.2% of weak performance observed at the federal level and 41.7% at the regional level. Key barriers to effective regulation were found to include a lack of research on herbal medicines (90.3%) and insufficient regulatory mechanisms (87.8%). Additional challenges for regulatory offices included traditional healers' reluctance to engage with scientific communities (56.5%), inadequate inspections (55.3%), and limited data on the safety, quality, and efficacy of certain medicinal plants (54.4%).Overall, the Ethiopian Food and Drug Authority (EFDA) is making significant progress in strengthening the legislative and regulatory framework for traditional herbal medicines (THM), although full implementation is still forthcoming. This study highlights the need for comprehensive policy development, improved training initiatives, and reinforced regulatory systems to effectively monitor and regulate THM practices. For future roadmaps, collaboration among traditional healers, regulatory bodies, and scientific communities, along with supporting evidence-based research, could further enhance THM regulation in Ethiopia.These collaborative endeavors are critical for promoting the safety and quality of products derived from herbal medicines.