In this study, the factors contributing to deficiencies in the bioequivalence sections of generic drug applications in Tanzania were explored, focusing on the perspectives of both Tanzania Medicines and Medical Devices Authority (TMDA) assessors and applicants who had registered generic medicines with TMDA. The primary objectives were to identify these aspects from the viewpoints of TMDA assessors and applicants and to offer recommendations for improving the quality of bioequivalence (BE) study submissions. By doing so, the study aims to expedite the regulatory approval process and guarantee the availability of safe and effective generic medications in Tanzania, ultimately improving public health. A qualitative methodology was employed, with fourteen (14) individuals participating in semistructured interviews, including seven (7) TMDA assessors and seven (7) applicants. Data was analyzed employing a thematic analysis approach, which led to the identification of key themes related to the factors contributing to deficiencies in BE submissions and offered recommendations for improving their quality. The research identified the primary causes of deficiencies as knowledge and training deficits, the complexity of guidelines, resource limitations, and the lack of local BE centers. Both TMDA assessors and applicants highlighted challenges such as reliance on international CROs, financial constraints, difficulties in interpreting TMDA requirements, and a lack of harmonization between international standards and TMDA guidelines. However, their focus varies: applicants are mostly concerned with logistical and financial challenges, especially the high costs of international CROs, while TMDA assessors emphasize adherence to guidelines, submission quality, and proper documentation. To effectively address both sets of concerns, a balanced strategy is required. Drawing from these findings, the study recommends strengthening training and capacitybuilding initiatives, enhancing communication and feedback systems, expanding regulatory capabilities, establishing local BE centers, standardizing guidelines, and reinforcing CRO audits. These enhancements aim to minimize shortcomings in BE applications, accelerate the regulatory approval process, and guarantee the accessibility of safe and effective generic drug products in Tanzania. This dissertation provides an in-depth understanding of the challenges within Tanzania's regulatory framework and offers practical recommendations for improving the quality of BE study submissions. These improvements aim to enhance access to affordable medicines and support better public health outcomes.