Background <p>No country is fully self-sufficient in meeting its pharmaceutical needs; yet significant disparities exist in export–import trade balances across nations. Ethiopia relies on pharmaceutical imports, exposing the health system to supply vulnerabilities and challenges in ensuring access to essential medicines. Addressing these challenges requires balanced policy frameworks and robust regulatory support to ensure consistent access, quality, and affordability of medicines. Within this context, the present study assessed the state of pharmaceutical imports in Ethiopia, and explored importers’ perspectives on the business environment and the national regulatory system.</p> Methods <p>An online survey-based descriptive study design was employed to assess the views and experiences of 78 eligible professionals working in pharmaceutical import companies. Stratified random sampling was utilized to choose the import firms. Data were analysed using SPSS version 26, with reliability and internal consistency tests performed. Descriptive statistics were used to summarize and interpret the findings.</p> Results <p>Seventy-one participants (91%) completed and returned the survey. The majority of respondents (74.4%) represented private limited companies and represented multiple foreign manufacturers primarily based in Asia (78.9%) and Europe (54.9%). The most commonly imported products were antimicrobials, analgesics, and medicines for gastrointestinal and cardiovascular diseases. Most respondents (77.4%) characterized the pharmaceutical import environment as unpredictable or recessionary, citing key challenges such as foreign currency shortages, policy-related barriers, and protracted regulatory processes. A substantial majority (77.5%) of respondents rated the capacity and performance of EFDA as good or very good, while 56.3% viewed the regulatory framework as favourable for pharmaceutical importation. Over one-third rated regulatory instruments as acceptable across most of the assessment criteria. Nevertheless, several challenges were identified, including inadequate stakeholder engagement, operational inefficiencies, limited transparency and ethical concerns, and insufficient technical expertise among reviewers, all of which were reported to undermine the effectiveness of the regulatory system.</p> Conclusion <p>Given the healthcare system’s dependence on reliable access to quality-assured medicines, balanced policy, and regulatory support are required to strengthen the pharmaceutical import sector, alongside the efforts to build local manufacturing capacity. The findings underscore the need for strategic improvements in both the business and regulatory frameworks such as coherent industrial and health policies, targeted financing mechanisms, expedited risk-based regulatory services, robust domestic manufacturing, and enhanced ethical standards, to optimize access to essential healthcare products.</p>