Pharmaceutical import landscape in Ethiopia: a cross-sectional study of importers’ perspectives on business and regulatory challenges

Abstract

Background

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.

Methods

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.

Results

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.

Conclusion

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.

Supplementary Information

The online version contains supplementary material available at 10.1186/s41182-026-01009-2.

Background

The global pharmaceutical industry, estimated to be worth $1.6 trillion in 2025 [1], is highly oligopolistic, with most leading companies concentrated in the United States and Europe. North America (53%), Europe (23%), China (8%), and Japan (7%) account for the largest shares of the global pharmaceutical market [2, 3]. The European Union’s pharmaceutical trade surplus reached a record €194 billion in 2024, with exports increasing by 148% over the past decade, compared with a 74% rise in imports over the same period [4].

Africa’s share in the global pharmaceutical market remains minimal. The continent accounts for less than 3% of global medicine production and approximately 1% of vaccine production [5, 6], with limited exports largely dominated by South Africa, Egypt, Algeria, Morocco, Tunisia and Kenya [7, 8]. Ethiopia’s pharmaceutical exports are minimal, valued at less than USD 3 million, primarily consisting of empty gelatin capsules and veterinary medicines [9]. Africa accounts for over 16% of the global population and bears a disproportionate burden of disease, yet receives less than 2% of global health spending, far below the global average of approximately 10% [10, 11]. More than 70% of pharmaceuticals consumed in Africa are imported, mainly from India and China [6, 10]. Similarly, Ethiopia imports 80–85% of its essential medicines. The high cost of imported medicines, not only limits access, but also contributes to illicit market activities and exposes health systems to economic and public health risks [6, 10]. In 2017, World Health Organization (WHO) reported that 42% of globally detected substandard and falsified (SF) medicines were found in Africa. Limited access to quality-assured medicines, weak regulatory systems, and corruption have been identified as key contributing factors [12, 13]. The vulnerability of import-reliance systems became particularly evident during regional conflicts [14, 15], and the COVID-19 pandemic, when global supply chain disruptions severely affected African health systems [16, 17].

Nevertheless, pharmaceutical importation plays an essential public health role, particularly in countries with limited local manufacturing capacity such as Ethiopia. Imported medicines are critical for ensuring access to essential medicines, stabilizing supply chains, and facilitating the transfer of technologies and innovations [18, 19]. When supported by appropriate policy and regulatory frameworks, the pharmaceutical import sector can also contribute to private sector development, strengthen the health workforce, enhance regulatory capacity, and generate employment opportunities [20–22].

National Regulatory Authorities (NRAs) are key actors in ensuring the effective functioning of pharmaceutical import systems. They serve as gatekeepers for public health by ensuring the safety, efficacy and quality of medicines and health technologies. Strong NRAs create a predictable regulatory environment for legitimate businesses while combating SF products. However, many African NRAs face capacity limitations including limited resources, fragmented institutional structures, inadequate use of technology, and weak law-enforcement mechanisms [23–25]. Weak regulatory systems create opportunities for market distortion, unethical practices and SF products, ultimately undermining both public health and legitimate business environments [26, 27].

In 2025, WHO reported that over a third of the global population, mainly from low- and middle-income countries (LMICs), lacked regular access to essential medicines and health technologies. More than 2 billion people face financial hardship due to out-of-pocket health expenditures, while an estimated $30.5 billion worth of SF medicines circulate in these regions [28, 29]. Structural deficits in the pharmaceutical trade balance have emerged as a growing challenge across LMICs, including countries within the BRICS10 bloc contributing to supply system vulnerabilities, and inequities in access to healthcare [30, 31].

Importing over 70% of its pharmaceutical needs, sub-Saharan Africa faces the most pressing challenges of import dependence, followed by the regions such as the Middle East, Latin America and the Caribbean, and parts of South and East Asia (excluding major producers such as India, China, and Bangladesh). Despite the growing local production capacity in countries like Brazil, Mexico and Argentina, much of Latin America remains reliant on pharmaceutical imports with dependence ranging from 54% in Mexico to as high as 88% in Peru [32]. In southeast Asia, significant growth in local manufacturing capacity has been recorded over the past two decades in India, China, and Bangladesh. However, many countries in the region including Vietnam, Philippines, Myanmar, Nepal and Indonesia continue to rely heavily on imported pharmaceuticals [33, 34]. Comparable patterns are observed in the Middle East, where import dependence ranges from approximately 60% in Saudi Arabia to over 80% in UAE and Lebanon [35].

This widespread import dependence is driven by a combination of structural, regulatory, and market-related determinants. Structural constraints play a significant role, including economic pressures, policy misalignments, weak domestic manufacturing capacity, and inefficient logistics systems. Regulatory challenges further contribute, encompassing limited technical capacity, weak enforcement mechanisms, and fragmented institutional frameworks. In addition, market-related issues, such as intellectual property regimes, information asymmetry, and governance inefficiencies reinforce this dependence [30]. At the same time, the rising burden of non-communicable diseases (NCDs) and increasing demand for advanced therapies are placing additional pressure on health systems to diversify pharmaceutical portfolios [36, 37].

In many LMICs, budgetary limitations necessitate procurement from lower-priced and often less stringently regulated markets, thereby increasing the risk of compromised product quality and safety. These risks are compounded by weak regulatory oversight, and the prevailing “buyer beware” paradigm, which places primary responsibility for product safety on importing countries [38]. Ethiopia reflects many of the above-mentioned structural characteristics. Collectively, these structural characteristics underscore the urgent need to strengthen import governance, enhance regulatory efficiency, and improve supply chain resilience across LMIC contexts.

In Ethiopia, the pharmaceutical import sector operates within an established regulatory and policy framework [39, 40]. Key regulatory requirements include: (i) appointment of a local agent holding a valid certificate of competence; (ii) submission of a verified Good Manufacturing Practice (GMP) certificate from the country of origin; (iii) product registration and market authorization; (iv) pre-approval of purchase orders or issuance of import permits; (v) provision of a valid certificate of analysis and consignment quality verification documents; (vi) compliance with port clearance procedures; (viii) adherence to minimum remaining shelf-life requirements of 15–30 months depending on product category; and (viii) implementation of product traceability and authenticity barcoding systems. Pharmaceutical imports benefit from preferential tax treatment, including exemptions from value added tax and excise tax, as well as reduced customs tariffs. In addition, pharmaceutical importers are often granted priority access to foreign exchange allocation through the National Bank of Ethiopia.

Due to underdeveloped domestic manufacturing capacity, heavy reliance on pharmaceutical imports, and high out-of-packet healthcare expenditure, rising medicine prices and recurrent stockouts of essential medicines have become major challenges for Ethiopia’s health system. A systematic review conducted in 2021 reported a mean national availability of essential medicines of 70.1%, with an average stockout duration of 92.2 days [41]. Similarly, a more recent systematic review [42] encompassing 46 studies across 2302 health facilities, found that the overall mean availability of essential medicines was 63.9%, substantially below the WHO target of 80%. Affordability also remains a significant concern. The review reported Median Price Ratios (MRPs) were 1.4 and 3.7 in public and private health facilities, respectively, indicating that prices of essential medicine were quite unaffordable, particularly in the private sectors.

In response, Ethiopia has prioritized pharmaceutical manufacturing as part of its industrialization agenda, and introduced several supportive policy measures [9, 43]. A key focus has been strengthening the Ethiopian Food and Drug Authority (EFDA), which has achieved WHO Maturity Level 3 status [44, 45]. For regulatory bodies such as EFDA, effective stakeholder engagement is critical to fostering trust and regulatory compliance by promoting transparency, improving operational efficiency, and supporting evidence-based decision-making [46, 47]. Importers represent a central stakeholder group; however, their perspectives on the strengths and weaknesses of the pharmaceutical import system remain underexplored. This study therefore investigates the pharmaceutical import landscape in Ethiopia, and explores importers’ perspectives on the business environment and the national regulatory framework to identify key operational and policy challenges and propose strategic interventions.

Methods

Research design and study setting

A survey-based descriptive study design was used based on a 3-domain conceptual framework (Fig. 1) to explore the perspectives of selected pharmaceutical importers of human medicines operating in Addis Ababa and its environs. During the period of data collection, 2833 companies were registered with EFDA to import medicines, food products, medical devices, and other healthcare supplies; however, the subset engaged specifically in the importation of human medicines was considerably smaller. Reconciled data obtained from EFDA and the Ethiopian Pharmaceuticals, Medical Supplies and Laboratory Reagents Importers and Wholesalers’ Association indicated that 97 companies were actively importing between 1 and 244 registered human medicines and medical devices. These companies were therefore considered the appropriate population for sample size determination.

Fig. 1.

Conceptual framework for assessing the pharmaceutical import business environment

Data collection methods

A structured self-administered questionnaire (Additional file 1) was used to collect data on the perspectives of professionals working in the selected import firms regarding the landscape of the pharmaceutical import sector. The instrument captured views on the capacity and performance of the EFDA, as well as the policy, operational and business-related challenges, and potential strategic interventions to improve the sector. The survey instrument was initially developed by the first author based on an extensive literature review. It was subsequently reviewed and refined by the senior co-authors. Face validity was assessed by two experts with extensive experience in the regulatory sector, and the instrument was finalized after incorporating their feedback.

Sample size determination and sampling procedures

The sample size was calculated using single population proportion formula [48] with adjustment for finite population (Eq. 1) [49]:

$$n=\frac{n_o}{1+\frac{\left(n_o-1\right)}{N}}.$$ 1

Based on a total of 97 eligible importers (N), a sample size (n) of 78 was determined from an initial calculated sample size (n_o) of 385 at a 95% confidence level and a 0.05 margin of error. Eligible participants included general or technical managers, regulatory affairs officers and marketing professionals from the selected import firms who had at least one year of work experience, were willing to participate, and were available during the data collection period.

Given that importers with varying numbers of registered products and years of operation could have various levels of interaction and experiences with EFDA, firms were stratified into six categories based on number of registered medicines (Table 1) to enhance representativeness. The final sample size was proportionally allocated across these strata, and representative importers from each category were selected using an open-source randomized software.

Table 1.

Categories of importers based on number of registered products

Group	Number of registered products	Number of importers	Allocated sample size
C1	1–5	28	23
C2	6–15	19	15
C3	16–35	24	19
C4	36–75	13	11
C5	76–125	9	7
C6	> 125	4	3
Total		97	78

Data collection and analysis

The selected participants completed the survey via online form distributed by email between January and February 2023, with regular follow-up reminders sent by the principal investigator via phone and email. Data were reviewed and cleaned on a daily basis to ensure that only complete responses were included in the analysis. Data analysis was conducted using SPSS version 26. Descriptive statistics, including frequencies, percentages, and weighted means, were used to summarize responses. Ordinal data obtained from Likert scale questions were analysed using weighted averages. The internal consistency and reliability of the survey instrument were assessed using Cronbach’s Alpha, with values exceeding 0.8, indicating excellent reliability and data quality (Table 2). For interpretation of Likert scale responses, a scale range of 5 (highest) and 1 (lowest) was applied, with an interval width of 0.8 used to response levels.

Table 2.

Reliability measures for study variables

No.	Variable name	No. of items	Sample size	Cronbach’s alpha value
1.	Import sector policies and business environment	17	71	0.872
2.	Policy and system related challenges	11	71	0.813
3.	Possible pharmaceutical sector support systems	12	71	0.821
4.	Participation in policy development and revision	11	71	0.967
5.	Influence of regulatory functions and procedures	16	31	0.844

Ethical considerations and confidentiality

Ethical clearance was obtained from the Institutional Review Board (IRB) of the author’s institution (CHS_IRB-086/19/SoP:02/2021). Informed verbal consent was obtained from all study participants after providing a clear written presentation of the study objectives and its significance. Participation was voluntary, and respondents were informed of their right to withdraw at any time without consequence. To ensure anonymity and confidentiality, no personal identifiers were collected during data collection or included in the analysis. Measures were also taken to minimize social desirability bias, including the use of a self-administered online questionnaire and assurances of confidentiality.

Results

Sociodemographic characteristics of study participants

Of the 78 participants approached, 71 completed and returned the online survey, yielding a response rate of 91%. Most participants were male (73.2%), aged between 31 and 50 years (78.9%) and had a pharmacy background (90.1%). As shown in Additional file 2, most held general or technical managerial positions, while only 17% served as regulatory affairs officers. Additionally, 75% of participants had more than ten years of professional experience and 62% held master’s degrees.

General profile of the pharmaceutical importers

Most importers (70.4%) operated as private limited companies, followed by sole proprietorships (18.3%) and share companies (11.3%). Over half (54.9%) represented between 1 and 5 foreign companies, whereas 5 importers represented over 20 entities (Fig. 2).

Fig. 2.

Number of foreign companies represented by local import firms (N = 71)

The majority of importers represented companies from Asia (78.9%) and Europe (54.9%) with only one importer reporting partnerships from Australia and Latin America. Most firms imported human medicines (93.0%) and medical devices (47.9%); however, relatively few dealt with innovator products and biopharmaceuticals (Table 3).

Table 3.

Types of products commonly imported by local importers (N = 71)

Product category	Responses, N (%)
	Yes	No
Human medicines	66 (93.0)	5 (7.0)
Veterinary medicines	6 (8.5)	65 (91.5)
Biopharmaceuticals	5 (7.0)	66 (93.0)
Medical devices	34 (47.9)	37 (52.1)
Vaccines	9 (12.7)	62 (87.3)
Diagnostic kits	15 (21.1)	56 (78.9)
Other healthcare supplies	18 (25.4)	53 (74.6)
Innovator products	13 (18.3)	58 (81.7)
Authorized generics	21 (29.6)	50 (70.4)
Branded generics	39 (54.9)	32 (45.1)
Regular generics	33 (46.5)	38 (53.5)
Biosimilars	5 (7.0)	66 (93.0)

Oral dosage forms were the most commonly imported while only a few firms reported inhalers and large volume parenterals (Fig. 3). The most frequently imported therapeutic categories included antimicrobials, gastrointestinal medicines, analgesics, and cardiovascular disorders (Table 4). In contrast, only a few importers dealt with blood products, immunological products, and anticancer agents.

Fig. 3.

Number of local agents importing different dosage forms (N = 71)

Table 4.

Number of firms importing different therapeutic categories (N = 71)

Therapeutic category	Responses, N (%)
	Yes	No
Analgesics	42 (59.2)	29 (40.8)
Gastrointestinal medicines	43 (60.6)	28 (39.4)
Cardiovascular medicines	35 (49.3)	36 (50.7)
Antidiabetic medicines	28 (39.4)	43 (60.6)
Respiratory tract medicines	32 (45.1)	39 (54.9)
Central nervous system medicines	16 (22.5)	55 (77.5)
Anaesthetic agents	11 (15.5)	60 (84.5)
Antimicrobial agents	53 (74.6)	18 (25.4)
Vitamins	25 (35.2)	46 (64.8)
Ophthalmic medicines	19 (26.8)	52 (73.2)
Dermatological preparations	28 (39.4)	43 (60.6)
Anticancer medicines	8 (11.3)	63 (88.7)
Blood related products	3 (4.2)	68 (95.8)
Immunological preparations	5 (7.0)	66 (93.0)
Antihistamines/anti-allergenics	26 (36.6)	45 (63.4)
Medicines for musculoskeletal diseases	22 (31.0)	49 (69.0)
Medicines for endocrine disorders	8 (11.3)	63 (88.7)
Medicines for reproductive health	9 (12.7)	62 (87.3)
Obstetrics and gynaecological medications	13 (18.3)	58 (81.7)
Electrolyte replacement agents	4 (5.6)	67 (94.4)

The state of pharmaceutical import business in Ethiopia

Participants were asked to assess the pharmaceutical import business across four consecutive three-year periods between 2011 and 2022. During the first and second periods, 43.7% and 53.5% of respondents, respectively, perceived the sector as attractive. However, in the latter two periods, approximately 45% of them described the sector as only acceptable or discouraging. Respondents also rated the influence of 17 policy- and business environment-related factors on the current business climate (Table 5). Most factors were perceived to have a moderate level of influence. Factors with the highest weighted average scores included inadequate access to foreign currency (4.52), financial policies (3.75), corruption/lack of good governance (3.63), and financial constraints (3.56). In contrast, competition from local products (2.18), market access (2.41) and intellectual property laws (2.42) were considered less influential.

Table 5.

Influence of policy and business-related factors on pharmaceutical import (N = 71)

Influencing factors	Responses, N (%)
	Very high influence	High influence	Medium influence	Low influence	Very low influence	WA**
Inadequate access to foreign currency	55 (77.5)	1 (1.4)	13 (18.3)	1 (1.4)	1 (1.4)	4.52
Financial policies	28 (39.4)	8 (11.3)	27 (38.0)	5 (7.0)	3 (4.2)	3.75
Corruption/lack of good governance	24 (33.8)	10 (14.1)	27 (38.0)	7 (9.9)	3 (4.2)	3.63
Financial constraints	20 (28.2)	10 (14.1)	33 (46.5)	6 (8.5)	2 (2.8)	3.56
Regulatory policies	14 (19.7)	15 (21.1)	29 (40.8)	8 (11.3)	5 (7.0)	3.35
Customs procedures	10 (14.1)	15 (21.1)	35 (49.3)	7 (9.9)	4 (5.6)	3.28
Low public purchasing capacity	6 (8.5)	20 (28.2)	32 (45.1)	6 (8.5)	7 (9.9)	3.17
Import policies	11 (15.5)	11 (15.5)	36 (50.7)	5 (7.0)	8 (11.3)	3.16
Trade policies	10 (14.1)	11 (15.5)	34 (47.9)	7 (9.9)	9 (12.7)	3.08
Low price imported medicines	9 (12.7)	10 (14.1)	35 (49.3)	9 (12.7)	8 (11.3)	3.04
Increasing market competition	7 (9.9)	12 (16.9)	34 (47.9)	12 (16.9)	6 (8.5)	3.03
Circulation of SF* products	8 (11.3)	11 (15.5)	33 (46.5)	11 (15.5)	8 (11.3)	3.00
Tax policies	8 (11.3)	8 (11.3)	27 (38.0)	15 (21.1)	13 (18.3)	2.76
Price/profit control policies	4 (5.6)	5 (7.0)	29 (40.8)	13 (18.3)	20 (28.2)	2.44
Intellectual property laws	3 (4.2)	3 (4.2)	36 (50.7)	8 (11.3)	21 (29.6)	2.42
Lack of market	1 (1.4)	6 (8.5)	33 (46.5)	12 (16.9)	19 (26.8)	2.41
Competition from local manufacturers	1 (1.4)	2 (2.8)	30 (42.3)	14 (19.7)	24 (33.8)	2.18

SF^* substandard and falsified, WA^** weighted average

Asked if pharmaceutical sector policies and support systems were encouraging, approximately half of the respondents (52.1%) indicated that pharmaceutical sector policies and support systems were encouraging. Nonetheless, several challenges were identified (Table 6), generally at a moderate level. The most influential challenges included import and export policies (3.70), regulatory policies (3.55), and customs procedures (3.41).

Table 6.

Major challenges for pharmaceutical import and their level of influence (N = 71)

Influencing factors	Responses, N (%)
	Very high influence	High influence	Moderate influence	Low influence	Very low influence	WA**
Import–export policies	21 (29.6)	12 (16.9)	33 (46.5)	3 (4.2)	1 (1.4)	3.70
Regulatory policies	20 (28.2)	8 (11.3)	36 (50.7)	5 (7.0)	2 (2.8)	3.55
Customs procedures	12 (16.9)	11 (15.5)	43 (60.6)	4 (5.6)	1 (1.4)	3.41
Finance and insurance policies	14 (19.7)	7 (9.9)	44 (62.0)	5 (7.0)	1 (1.4)	3.39
Industry policy	6 (8.5)	11 (15.5)	48 (67.6)	4 (5.6)	2 (2.8)	3.21
Investment policy	4 (5.6)	11 (15.5)	46 (64.8)	8 (11.3)	2 (2.8)	3.10
National medicines policy	5 (7.0)	12 (16.9)	41 (57.7)	11 (15.5)	2 (2.8)	3.10
National health policy	6 (8.5)	8 (11.3)	43(60.6)	12(16.9)	2(2.8)	3.06
Tax systems on import	6(8.5)	8(11.3)	44 (62.0)	8 (11.3)	5 (7.0)	3.03
License requirements	8 (11.3)	5 (7.0)	39 (54.9)	11 (15.5)	8 (11.3)	2.92
Intellectual property rights policies	5 (7.0)	3 (4.2)	43 (60.6)	14 (19.7)	6 (8.5)	2.82

WA^** weighted average

A large majority of participants (94.4%) reported implementing mitigation strategies to address these challenges and most (83.1%) considered these interventions were effective in sustaining their business. Common strategies included increasing financial investment, diversifying into other sectors, downsizing staff, and expanding supplier networks and product portfolios. Asked about future prospects, 53.5% of respondents described the pharmaceutical import sector as unpredictable, 23.9% as declining, and only 22.5% as promising. Key limiting factors identified included restrictive import policies, regulatory procedures, the circulation of SF products, and competition from low-cost alternatives. Participants also rated the importance of 12 potential strategies to strengthen the pharmaceutical sector (Fig. 4). The most frequently identified priorities included improved access to foreign currency (85.9%), expediting product registration procedures (74.6%), strengthening local production (73.2%), and the establishment of sector-specific financing mechanisms (73.2%).

Fig. 4.

Contribution of different support systems for the pharmaceutical sector (N = 71)

Importers’ perspectives on the national regulatory environment

When asked to evaluate the capacity and performance of the EFDA using a 5-point Likert scale (excellent to very weak), approximately (77.5%) of respondents rated the capacity and performance of EFDA as good or very good, while the remainder rated it as weak or very weak. To further explore this, participants assessed EFDA’s regulatory instruments including policies, regulations, directives, and guidelines, across ten parameters (Fig. 5). Over one-third of respondents rated these instruments as acceptable across most criteria. The highest ratings were observed for accessibility (76.1%), communication (49.3%), and scope (47.8%). In contrast, lower ratings were given to training on new or revised instruments and the timeliness of regulatory updates, with 40.9% and 33.9% of respondents, respectively, rating these areas as poor or very poor.

Fig. 5.

Ratings associated with the national regulatory instruments (N = 71)

EFDA’s Citizens’ Charter emphasizes stakeholder engagement; however, respondents reported generally low levels of participation in policy development and revision (Fig. 6). Engagement was limited in areas such as treatment guidelines, investment policies, the national medicines formulary, and health transformation plans. Relatively, better engagement was reported in the development and revision of storage and distribution guidelines (36.6%), market authorization directives (36.6%), and import directives (31.0%).

Fig. 6.

Level of participation during policy development and revision (N = 71)

Overall, 56.3% of the participants considered the national regulatory environment as favourable for pharmaceutical import. Those with less favourable views identified key barriers (Table 7), including market authorization procedures (4.32), registration renewal (3.84), lack of transparency and unethical practices (3.81), and limited competency of regulatory officers (3.81). In contrast, price regulations, pharmacovigilance requirements, and prescribing and dispensing policies were perceived as less influential (weighted averages below 2.75).

Table 7.

Impact of regulatory policies and functions on pharmaceutical import business (N = 31)

Regulatory policies and functions	Responses, N (%)
	Very high influence	High influence	Moderate influence	Low influence	No influence	WA
Market authorization procedures	19 (61.3)	6 (19.4)	3 (9.7)	3 (9.7)	0 (0.0)	4.32
Registration renewal procedures	13 (41.9)	6 (19.4)	7 (22.6)	4 (12.9)	1 (3.2)	3.84
Competency problem of experts	9 (29.0)	10 (32.3)	9 (29.0)	3 (9.7)	0 (0.0)	3.81
Unethical practices by experts	13 (41.9)	4 (12.9)	10 (32.3)	3 (9.7)	1 (3.2)	3.81
Quality verification testing	12 (38.7)	6 (19.4)	9 (29.0)	1 (3.2)	3 (9.7)	3.74
Corruption/lack of transparency	11 (35.5)	7 (22.6)	6 (19.4)	4 (12.9)	3 (9.7)	3.61
Law enforcement activities	5 (16.1)	9 (29.0)	12 (38.7)	3 (9.7)	2 (6.5)	3.39
Facility inspection and licensing	8 (25.8)	5 (16.1)	8 (25.8)	6 (19.4)	4 (12.9)	3.23
Higher service fees	5 (16.1)	6 (19.4)	8 (25.8)	8 (25.8)	4 (12.9)	3.00
Supply chain security requirements	4 (12.9)	5 (16.1)	9 (29.0)	12 (38.7)	1 (3.2)	2.97
Post-marketing surveillance	4 (12.9)	8 (25.8)	4 (12.9)	11 (35.5)	4 (12.9)	2.90
Recalls and complaint handling	4 (12.9)	5 (16.1)	9 (29.0)	8 (25.8)	5 (16.1)	2.84
Promotion/advertising regulations	2 (6.5)	7 (22.6)	9 (29.0)	9 (29.0)	4 (12.9)	2.81
Prescribing and dispensing policies	4 (12.9)	3 (9.7)	9 (29.0)	9 (29.0)	6 (19.4)	2.68
Pharmacovigilance requirements	3 (9.7)	6 (19.4)	6 (19.4)	6 (19.4)	10 (32.3)	2.55
Price/profit control regulations	3 (9.7)	2 (6.5)	8 (25.8)	7 (22.6)	11 (35.5)	2.32

Finally, respondents identified several strategies to improve regulatory capacity and performance (Fig. 7). The most strongly supported interventions included enhancing the competency of regulatory personnel (87.3%), improving transparency and governance (84.5%), and promoting ethical practices (78.9%).

Fig. 7.

Strategies to improve the capacity and performance of the national regulatory system (N = 71)

Discussion

The global pharmaceutical market operates as a highly specialized and interdependent system for both input materials and finished products, yet it is marked by fragmented supply chains. Although no country is fully self-sufficient in meeting its pharmaceutical needs, the degree of import reliance varies considerably. LMICs, despite hosting over 85% of the global population, are largely net pharmaceutical importers and often exhibit health system vulnerabilities due to restricted access to essential medicines and health technologies [29, 50]. These countries share similar structural constraints, including inadequate local manufacturing capacity, limited regulatory competence, fragile supply chains, and systemic vulnerability to external market volatility and currency fluctuations [27, 30].

Countries in sub-Saharan Africa rely heavily on imports [6, 51]. Between 2015 and 2019, intra-continental pharmaceutical trade in Africa was estimated as only 2% compared with 47% in the Americas, 61% in Asia, 67% in Europe and 7% in Oceania [52]. This heavy reliance on imports, compounded by socioeconomic barriers, limits access to essential medicines and vaccines, and increases vulnerability to supply disruptions, as observed during the COVID-19 pandemic [9, 51–53]. These challenges contribute to persistent chronic shortages, economic vulnerability, and regulatory difficulties in ensuring medicine quality in countries such as Ethiopia. In Ethiopia, reliance on pharmaceutical import is particularly pronounced, amplifying vulnerability to supply chain disruptions. Systematic reviews in the area reported 63.9% overall mean availability of essential medicines, quite lower than the 80% target by WHO, with repeated stockouts, and higher Median Price Ratios, underscoring the critical pressure on the national health system and individual patients [41, 42].

This study found that Ethiopia has a relatively considerable number of pharmaceutical importers, many of which represent multiple foreign manufacturers. Such diversity in supply sources offers strategic advantages by improving market access, expanding product portfolios, and helping to balance resource constraints. A strong local import and distribution network can also facilitate foreign manufacturers by leveraging domestic human resources and logistical capacity to navigate complex regulatory systems. However, this framework may also introduce risks, including conflicts of interest, price inflation, and supply chain management hurdles.

The findings further indicate that most Ethiopian importers represent companies from Asia (primarily from India and China), and Europe. This pattern mirrors global supply dynamics, as India is a leading supplier of pharmaceutical products to Africa [54, 55], and Ethiopia’s price-sensitive market benefits from competitively priced generic medicines from Asian manufacturers. However, this same price sensitivity may increase vulnerability to the infiltration of SF products, particularly in the context of limited regulatory capacity and weak supply chain control. Southeast Asia has been identified as the major source of SF medicines, while sub-Saharan Africa remains a key destination, accounting for approximately 42% of the globally reported cases [56–58].

Most importing companies maintain portfolios dominated by oral solid dosage forms of generic medicines including antimicrobials, treatments for respiratory and gastrointestinal conditions, antidiabetics, antihistamines, analgesics, and dermatological preparations. In contrast, fewer companies import essential biopharmaceuticals and medicines for NCDs, which are frequently in short supply [41, 59]. Similar trends have been reported across sub-Saharan Africa [60, 61]. This pattern may reflect Ethiopia’s historical focus on communicable diseases. However, the rising burden of NCDs [62, 63] has prompted recent policy revisions aimed at reshaping the pharmaceutical market. Whether these changes will significantly alter import patterns remains uncertain.

A notable concern identified in this study is the perception among many participants that the pharmaceutical import business has become increasingly discouraging, with uncertain future outlook. While this may partly reflect the impact of the COVID-19 pandemic and pressures on the generics market, local challenges appear to be more influential. These include foreign currency shortages, restrictive financial and regulatory policies, broader financial constraints, and governance-related issues. Private importers are facing intense pressure due to the growing demand for foreign currency from domestic manufacturers and cross-industry buyers. This situation is further complicated by the slow export growth, recent financial reforms, and heavy public spending on infrastructure [64–66]. Comparable challenges have been reported elsewhere in Africa and other low-income regions [6, 67, 68], where regulatory barriers, supply chain inefficiencies, infrastructure limitations, and economic volatility continue to constrain pharmaceutical markets [69].

Most participants rated the overall capacity and performance of the EFDA as good; regulatory instruments were generally considered acceptable. However, gaps remain in timely revision of regulatory instruments, as well as in training and communication with stakeholders regarding new or updated policies. Importers also reported limited involvement in regulatory policy development and revision, despite their central role in medicines supply. Similar findings have been reported in other settings, where inadequate stakeholder participation has contributed to poorly contextualized policies, reduced compliance, and weakened trust between regulators and stakeholders [24, 70, 71]. Insufficient consultation with manufacturers and importers during regulatory policy development and revision creates implementation gaps and information asymmetry, and undermines enforcement legitimacy. Strengthening stakeholder engagement through systematic consultation, feedback mechanisms, and participation in policy review processes may enhance regulatory effectiveness and transparency.

For pharmaceutical importers, key regulatory requirements, including the validity of compliance certificates, product registration and market authorization procedures, purchase order pre-approvals and import permits, consignment quality verification documents, and port clearance processes, have a significant impact on business operations and viability [40]. In the present study, only 56.3% of the respondents viewed the national regulatory environment as favourable for pharmaceutical importation. The principal barriers identified included protracted core regulatory procedures, particularly facility inspections, product registration, market authorization, and quality control testing. In addition, deficiencies in transparency, governance, ethical practices, and technical competency of regulatory personnel were reported to further constrain sector performance. A comprehensive review Ethiopia’s regulatory framework similarly identified weak regulatory enforcement, inadequate port and post-market controls, the circulation of SF products, resource constraints, and insufficient coordination among responsible institutions as major challenges facing the sector [72].

Likewise, a recent systematic review of over one hundred studies identified multiple challenges affecting supply system management and access to medicines in developing countries, including policy-related barriers, financial constraints, frequent stockouts, the circulation of counterfeit medicines, shortage of qualified personnel, technical and infrastructure limitations and limited data visibility [68]. In addition, other studies have highlighted fragmented regulatory requirements and procedures as major barriers to the registration and supply of medicines in African countries [73, 74].

For Ethiopia, achieving long-term pharmaceutical self-reliance will require sustained investment in domestic manufacturing capacity. However, given the current constraints, pharmaceutical imports will remain essential to ensuring access to a wide range of medicines. Accordingly, strengthening the import sector through targeted regulatory and policy interventions is critical. Study participants emphasized the importance of enhancing technical capacity with regulatory institutions, improving transparency and governance, streamlining regulatory and customs procedures, and updating regulatory policy frameworks. Additional strategies such as digitizing regulatory processes, strengthening supply chain security, implementing risk-based post-market surveillance and pharmacovigilance, and fostering public–private collaboration, may further support a resilient and efficient pharmaceutical system.

Limitations of the study

Some limitations of this study acknowledged include inherent limitations of the cross-sectional study design, the reliance on descriptive statistical analysis, which precluded the assessment of causal or associative relationships, and the absence of rigorous content validation of the survey instrument. In addition, the study reflects the perspectives of a single stakeholder group based in Addis Ababa, which may limit the generalizability of the findings. Comparative, multi-stakeholder group assessments, including qualitative inquiries, would provide a more comprehensive understanding.

Conclusion

Ethiopia remains highly reliant on pharmaceutical imports making it vulnerable to global and regional supply chain disruptions. While the country benefits from a relatively diverse pool of importers supplying mainly generic medicines, gaps remain in access to biopharmaceuticals, medicines for NCDs, and advanced formulations.

The pharmaceutical import environment is increasingly perceived as challenging and unpredictable. Key constraints include foreign currency shortages, financial and regulatory barriers, and concerns related to transparency and governance. Although the national regulatory system was generally considered functional, improvements are needed in stakeholder engagement, efficiency of regulatory processes, transparency, and technical capacity.

Like many LMICs, Ethiopia faces comparable socioeconomic, structural, regulatory and supply chain constraints that exacerbate health system vulnerabilities. Addressing these challenges requires coherent alignment between health and industrial policies, digitization of core regulatory functions, implementation of risk-based inspection systems, expedited registration and approval pathways, strengthened stakeholder consultation mechanisms, and participation in regulatory harmonization initiatives to enhance regulatory performance and supply chain resilience. Given Ethiopia’s growing demand for pharmaceuticals, investment in local manufacturing remains a strategic imperative. However, pharmaceutical imports will continue to play a critical role in the foreseeable future underscoring the need for judiciously crafted policies and targeted support mechanisms that ensure reliable access to quality-assured medicines.

Abbreviations

EFDA

Ethiopian Food and Drug Authority

NCDs

Non-communicable diseases

NRAs

National Regulatory Authorities

SF

Substandard and falsified

WA

Weighted average

WHO

World Health Organization

Author contributions

TM: conceptualization, methodology, data collection, data curation, formal analysis, and writing the original draft. TGM: conceptualization, methodology, visualization, review and editing, supervision, and project administration. AB: conceptualization, methodology, review and editing, and supervision. FJR: conceptualization, visualization, review and editing, and supervision.

Funding

The first author received a small amount of funds from the Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Science, Addis Ababa University, and Armauer Hansen Research Institute (AHRI) that could cover the cost of data collection.

Data availability

All data generated or analysed during the study are present in this article.

Declarations

Ethics approval and consent to participate

Ethical clearance was obtained from the Institutional Review Board of the College of Health Sciences, Addis Ababa University (CHS_IRB-086/19/SoP:02/2021). Informed verbal consent was obtained from all study participants prior to data collection. To maintain confidentiality, no personal identifiers were used during data analysis and reporting of the findings.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.