Background: 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. In developing countries, it is difficult to guarantee the safety and quality of THM due to weak enforcement of the legal and regulatory framework. Hence, the study attempted to evaluate the country’s legislative and regulatory framework by comparing it with developed and developing countries that have well-established systems and identify gaps for future roadmaps in the THM landscape.Methods: A cross-sectional study and archival review were performed from November 2021 to March 2022 G.C. to contrast the legislative and regulatory framework for THM regulation with other selected countries like Africa, India, and China. A total of 237 regulatory personnel participated in the study. Data were collected through an archive assessment, self-administrative questionnaires, and literature searches. Secondary data were extracted from the archival review, and the findings were summarized and presented in tabular and text formats. The quantitative data were analyzed using Statistical Package for the Social Sciences (SPSS) software version 26, with outputs presented in text, table, and figure form.Results: 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, 82.3% reported they had not received any formal training on THM regulations. For future roadmaps, 73.8% of respondents believed the government showed a commitment to supporting THM regulation, though 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, most 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 included 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%).Conclusion: Overall, the Ethiopian Food and Drug Authority (EFDA) is significantly 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.

Background: The provision of medicines with confirmed quality and efficacy is critical for maintaining the public health and building confidence in the healthcare systems. However, the presence of poor-quality medicines still presents a significant challenge in the pharmaceutical landscape across the African regions. This is further exacerbated by the lack of consistency or discrepancy in the current regulatory framework. As a consequence, given the current constraints, a robust regulatory structure that can guarantee the supply chains attainment of the intended medicinal product requirements are required.Objective: The review aimed to provide a detailed analysis of the quality issues in the pharmaceutical supply in Africa, highlighting the challenges and proposing potential solutions for its mitigation.Methods: The review was conducted from May 2023 to April 2024. This narrative review examined poor-quality medicines, regulatory challenges, and mitigation strategies in the African pharmaceutical industry. The review utilized databases such as Google Scholar, PubMed, and Web of Science. The search strategy was customized to include open-access articles published in peer-reviewed scientific journals in English and focused exclusively on studies conducted in African countries.Results: The review portrays the prevalence of poor-quality medicinal products in various regions of Africa. Among various categories of findings, 42% of the reports on poor-quality medicinal products come from the African region, as per the WHO report. Furthermore, separate findings on substandard medicinal products from many African countries were encountered. The presence of problems in the regulatory system, such as the absence of any pharmacopeia belonging to any African country and variation/inconsistency in each country’s regulatory set-up, was indicated. Other factors for the inability to enforce regulatory law, such as insufficient skilled and committed human resources, the presence of corruption, as well as financial resource scarcity, were revealed in the review. From the situational analysis, the possibility of building a robust quality assurance system in the near future through a quality by design approach under existing resource limitations was discussed.Conclusion: The pharmaceutical sector in Africa faces significant challenges, including the prevalence of poor-quality medicines and weak regulatory enforcement. Tackling these challenges are vital for enhancing health outcomes throughout the continent through the provision of high-quality medicines. Trending toward quality by design in the quality assurance system under prevailing financial scarcity can be very beneficial.

Background: Approximately 80% of the Ethiopian population predominantly depends on herbal medicines (HMs) for their primary healthcare needs. Nevertheless, worries regarding the safety, efficacy, and standard of herbal-based treatments have been escalating due to the lack of strong regulatory frameworks. Therefore, the study aimed to assess the presence of regulatory frameworks for traditional herbal medicines and their enforcement in Ethiopia.Methods: The qualitative–phenomenological study design was conducted from November 2021 to March 2022 G.C. The study included 25 regulatory official key informants (KIs) who work for national and regional medicine regulatory agencies, and 15 traditional herbal medicine (THM) practitioners who work at the regional level were purposefully selected for an in-depth interview (IDI). An in-depth interview guide was developed through the purposive sampling technique. The collected data were analyzed using thematic content analysis techniques.Results: The study found that the current national medicine proclamation is deemed inadequate in the regulation of THM. Both conventional and traditional herbal medicines are regulated by a single agency. Weak legal enforcement, a lack of government commitment and support, resource constraints, and inadequate regulatory tools are the main challenges faced in THM regulation.Conclusion: Overall, the study found inadequate legal frameworks and weak THM regulatory implementations in Ethiopia. Consequently, it is critical for all regulatory authorities in Ethiopia to exert their utmost efforts to effectively regulate THM.

Background: The magnitude of expired medicines in supply chains are increasing globally due to lack of strict control of the supply chain, poor storage management and oversupply of medicines. This situation is very serious in resource-poor countries, including Ethiopia, where the supply of medicines is limited. Therefore, this study aimed to assess the magnitude and the contributing factors of expired medicines in the Public Pharmaceutical Supply Chains of Western Ethiopia. Methods: Explanatory sequential study design involving mixed quantitative and qualitative approach were employed among 62 public pharmaceutical supply chains of Western Ethiopia from July1 to August 30, 2021. An observational checklist and the self-administered questionnaire were used to review all records of the expired medicine file and to abstract secondary data on the extent, types of expired medicines and its contributing factors. The collected data was cleared, filtered, and coded using Microsoft Excel® 2010, and exported to SPSS version-23 (Amsterdam, Netherland) for statistical analysis. Bivariate logistic regression was used to check association between the outcome and independent variables. Multivariate logistic regression was analyzed when p-value is less than or equal to 0.25 in bivariate binary logistic regression, considering the statistical at p-value < 0.05. Moreover, audio recordings were transcribed and coded for emergent themes using thematic analysis. Results: The study revealed 5% expire rate over past two financial (2012 up to 2013) years and the total amount of expired drugs is estimated at 20 million Ethiopian Birr (ETB). Tetanus antitoxin (TAT), in terms of single drug value, had the highest drug expiry (4,110,426.43ETB: 20%), followed by liquid dosage forms (11,614,266.11 ETB: 57%). The Binary logistic regression result indicated that, poor store management were more likely associated with the magnitude of expired medicine than those with good store management (COR: 10.706, 95% CI: 2.148, 53.348). Multivariate logistic regression revealed that poor store management (AOR: 9.718, 95% CI: 1.474, 64.082) was a significant contributor to the expire rate at 5% (P < 0.05). Most facilities did not have a procedure, and programme for disposing of expired medicines. According to key informants, inadequate inventory management, lack of policy and implementation of standards are the main contributing factors of the medicine's expiration. Conclusion and recommendations: The current study found that the overall rate of medication expiration is high, at a significant cost to the budget. Inadequate inventory management, lack of policy, and implementation of standards are the main contributing factors to the medicine's expiration, as cited by key informants. Further research is necessary to determine the quality and efficacy of these expired drugs to extend their shelf life to ensure adequate access to drugs in resource-limited settings.

Background: Veterinary pharmaceuticals must be safe and effective for treating and preventing diseases in animal sectors. Strict adherence to regulations at every stage of production, storage, and administration is necessary as the global sector grows in order to lower the possibility of adverse veterinary drug events. Strong pharmacovigilance regulatory systems are critical in monitoring and managing safety concerns related with veterinary pharmaceuticals.Objective: This review aimed to investigate the implementation of veterinary pharmacovigilance, collaborative initiatives, and reporting practices within the veterinary sector across East African countries.Methods: A thorough search was performed using online platforms such as Google Scholar, PubMed, the Web of Sciences, and regulatory Web sites. The search strategies relied heavily on selecting relevant published findings related to veterinary pharmacovigilance status, veterinary adverse drug event reporting practice, and collaborative efforts in veterinary pharmaceutical sectors within the East African landscape. This article search approach confirmed the inclusion state of veterinary pharmacovigilance and associated collaborative initiatives in the region.Results: In comparison to more developed regions, the review indicated that the veterinary pharmacovigilance system in East African countries was still in its early state. A strong legislative foundation and a large commitment from the veterinary profession are needed to establish a nationwide veterinary pharmacovigilance system. The review reveals a significant lack of consistency in the infrastructure of veterinary pharmacovigilance among the countries of East Africa. Tanzania, Kenya, and Ethiopia have some institutional processes for veterinary pharmaceutical safety, but they lack thorough documentation, which suggests that this systems still require improvement. The analysis emphasizes how inadequate the reporting systems are for adverse veterinary medication events in the majority of East African nations. Given the challenges East Africa faces, customized strategies are required to guarantee the safety and oversight of veterinary medications and improve veterinary pharmacovigilance. For systems to be more effective, veterinary pharmaceutical legal frameworks must be strengthened and stakeholder collaboration must be improved. Stakeholders include legislators, law enforcement, customs officials, regulatory organizations, scientists, pharmaceutical businesses, veterinarians, farmers, and the general public.Conclusion: A multidisciplinary strategy is needed to solve current gaps in veterinary pharmacovigilance and improve overall veterinary drug safety in East Africa. It is feasible to create more reliable methods for tracking and guaranteeing the safety of veterinary medications by combining the efforts of numerous stakeholders, including as legislators, regulatory agencies, veterinary practitioners, and the general public.

Background: Azithromycin is a therapeutically” relevant macrolide antibiotic registered on the Essential Medicines List of the World Health Organization. The fact that medicine is selected as an essential drug doesn’t mean that it is of good quality. Hence, a continuous quality evaluation of the drug should be mandated to verify that the right medication is available on the market. Objective: To evaluate the quality of Azithromycin Tablets commonly marketed in Adama, and Modjo town, Oromia Regional State, Ethiopia. Methods: All six brands were subjected to in-vitro quality control tests, which were carried out according to procedures described in the manufacturer’s method, the United States Pharmacopeia, and the WHO inspection tool. All quality control parameters were compared by one-way ANOVA. Statistically, significant difference was considered when P<0.05. The in-vitro dissolution profiles of the brands were also compared statistically using the post-hoc Dunnett test, model-independent and model-dependent approaches. Results: All of the evaluated brands agreed with WHO visual inspection criteria. All of the tablets achieved the thickness, and diameter test requirements of the manufacturer’s specification (±5%). All brands passed the hardness, friability, weight variation, disintegration, identity, and assay tests as stipulated by USP. The dissolution rate was more than 80% in 30 minutes, which was within the USP specification. The model-independent parameters have confirmed that only two brands (2/6) were deemed better brands for interchangeability. Weibull and Korsemeyer’s Peppas model were the best release models. Conclusion: All of the evaluated brands passed the quality specification. The model dependent approaches revealed that drug release data fit well to the Weibull, and Korsemeyer’s Peppas release models. However, the model-independent parameters have confirmed that only two brands were deemed better brands (2/6) for interchangeability. Due to the dynamic nature of low-quality medications, the Ethiopian Food, and Drug Authority should keep an eye on marketed products to guarantee their quality, especially for drugs like azithromycin for which non-bioequivalence data from the study has revealed a clinical concern.