Analysing the Impact of the AfCFTA on Pharmaceutical Access and Health Technology Policy in Mozambique: A 2021-2026 Outlook

Introduction

The existing literature on the African Continental Free Trade Area (AfCFTA) offers pertinent, though often indirect, evidence regarding its potential impact on access to medicines and medical technologies in Mozambique ((Adedokun, 2024)). Several studies investigating the agreement’s broader economic and trade implications arrive at complementary conclusions relevant to this issue. For instance, research on increasing trade and investment highlights the AfCFTA’s potential to reshape market structures, a fundamental precondition for altering pharmaceutical supply chains ^2,22. Similarly, analyses of customs administration and tax interplay underscore that operational efficiencies and fiscal policies are critical determinants of whether theoretical trade gains translate into affordable, timely access to medical products ^13,16. This pattern is further supported by examinations of competition enforcement and export diversification, which affirm that the rules governing market conduct and production specialisation will influence the availability and pricing of medicines ^3,14.

However, this emerging consensus is not universal, and significant contextual divergences are apparent ((Aliyu et al., 2025)). Some studies report differing outcomes, suggesting that the AfCFTA’s impact is highly contingent on specific sectoral and national conditions ((Beckman et al., 2024)). For example, investigations into areas such as monetary union feasibility, banking sector development, and climate change implications present distinct sets of challenges and priorities that could compete with or complicate health sector objectives ^8,25,23. Furthermore, research on Africa’s trade agency in a fragmented global landscape cautions that external factors may limit the AfCFTA’s promise ¹⁵. Crucially, while this body of work provides a valuable foundation, it frequently does not fully resolve the specific contextual mechanisms linking trade liberalisation under the AfCFTA to tangible health outcomes in Mozambique. A key gap remains in explicitly analysing how the agreement’s protocols interact with national regulatory frameworks, intellectual property environments, and local health systems to affect access. This article addresses that gap by examining the broader regulatory and policy context in which the AfCFTA will operate, a necessary step for understanding its practical implications for medicine and medical technology access.

Policy Context

Mozambique’s pharmaceutical and health technology landscape, prior to the African Continental Free Trade Area (AfCFTA), was defined by a pronounced gap between policy ambition and systemic capacity ⁹. The National Pharmaceutical Policy and Essential Medicines List formally prioritised equitable access to quality-assured medicines ¹⁰. However, implementation was critically constrained by fragmented regulation, chronic underfunding, and an overwhelming reliance on imported finished products ²¹. This dependency mirrored a continental vulnerability, exposing the health system to external supply shocks and foreign exchange volatility ⁷.

Regionally, Mozambique’s trade was shaped by its Southern African Development Community (SADC) membership ¹². Despite protocols aiming to facilitate trade, progress on harmonising medicines regulation remained slow, perpetuating significant non-tariff barriers (NTBs) ¹³. A fragmented regulatory architecture, involving lengthy duplicative registration processes with the Autoridade Reguladora Nacional (ARN) and inconsistent standards, directly inflated medicine costs ⁴. Furthermore, Mozambique’s intellectual property regime, like many low-income countries, underutilised TRIPS Agreement flexibilities to stimulate generic competition ⁵.

These weaknesses were compounded by severely limited local production capacity ¹⁴. Local manufacturing, focused on simple generics, lacked the scale and technological sophistication to produce active pharmaceutical ingredients or meet substantial domestic demand, perpetuating systemic dependency ¹⁵. Consequently, stakeholders operated within a paradigm of scarcity and high-cost procurement, with the ARN strained between ensuring quality control and accelerating essential medicine access.

The AfCFTA’s implementation from 2021 constitutes a profound exogenous shift, aiming to create a single market through tariff elimination and NTB reduction ^16,17. For pharmaceuticals, it theoretically enables diversified sourcing, competitive pricing, and economies of scale ((Ngobeni, 2025)). Its developmental regionalism logic also aligns with Mozambique’s interest in stimulating local industry by granting preferential access to a vast continental market ⁸.

Nevertheless, integration introduces acute policy complexity ¹⁸. Mozambique must navigate an "impossible trinity" of objectives: preserving regulatory sovereignty, pursuing deep integration, and maintaining policy stability ¹⁹. The coexistence of the AfCFTA with SADC creates a multi-layered governance challenge ²². Politically, liberalisation may disrupt entrenched interests, while socially, benefits risk being unevenly distributed, potentially exacerbating access inequalities ³.

Thus, the policy context from 2021 to 2026 is one of simultaneous constraint and opportunity ²⁰. The AfCFTA disrupts a status quo of fragmentation and dependency, offering a pathway to address these through harmonisation and scaled production ((Prabhakar, 2025)). Yet, it simultaneously demands sophisticated national responses to mitigate risks to regulatory sovereignty, market stability, and equitable distribution. This evolving context frames the critical analysis of how Mozambique’s frameworks can be adapted to harness the agreement for improved pharmaceutical access and health security.

Policy Analysis Framework

The existing literature on the African Continental Free Trade Area (AfCFTA) provides a foundational, yet incomplete, understanding of its potential impact on access to medicines and medical technologies in Mozambique ((Sani & Mandina, 2025)). A body of research highlights the agreement's general relevance to this sector, emphasising its role in reducing tariffs, harmonising regulations, and fostering regional value chains that could theoretically enhance availability and affordability ^22,5,15. For instance, studies on customs digitalisation and trade facilitation underscore how streamlined border procedures under the AfCFTA could reduce costs and delays for medical imports ¹³. Similarly, analyses of competition policy and fair-trade practices identify frameworks essential for preventing market abuses that could keep drug prices high ¹⁴.

However, this evidence often remains broad, treating healthcare as one sector among many without fully resolving the specific contextual mechanisms that determine outcomes in Mozambique ((Tadelle, 2025)). As Kyereboah-Coleman et al ((Turkson, 2024)). (2025) note, the AfCFTA's effects are mediated by national infrastructure and policy environments. Critical divergences in the literature further illustrate this complexity. While some studies point to the benefits of integrated markets ¹⁶, others caution that without parallel fiscal harmonisation or industrial policy, the agreement could exacerbate trade imbalances and undermine local pharmaceutical production ^25,2. This suggests that the net impact on medicine access is not automatic but contingent on complementary domestic policies and international support mechanisms ^19,6.

Consequently, a significant gap persists ((Warikandwa et al., 2025)). The current framework does not adequately account for Mozambique's specific vulnerabilities and capacities, such as its dependence on medical imports, regulatory readiness, and the capability of its health systems to manage changed trade flows ^12,20. This article addresses these unresolved contextual explanations by applying a policy analysis framework that interrogates how the AfCFTA's general provisions interact with Mozambique's distinct economic and institutional landscape to ultimately shape access to essential health commodities.

Policy Assessment

The policy assessment for Mozambique’s pharmaceutical sector under the African Continental Free Trade Area (AfCFTA) necessitates a multi-faceted examination of specific provisions and their interaction with national health objectives ⁵. A central pillar is the analysis of tariff phase-out schedules for products categorised as essential medicines ⁶. While the progressive elimination of import duties over five to ten years presents a direct mechanism for reducing the landed cost of imported medicines, the fiscal implications are significant for a nation with constrained revenue streams ⁴. This creates a policy tension between fiscal stability and health access gains. Crucially, the success of this schedule in improving affordability is contingent on complementary measures to prevent the substitution of tariff barriers with non-tariff measures (NTMs), which historically constrain intra-African trade more substantially than tariffs ⁸.

Concurrently, the assessment must scrutinise the Rules of Origin (RoO) protocols, which determine whether products manufactured within the continent qualify for preferential treatment ⁷. Designed to stimulate regional value chains, these RoO present a strategic opportunity for Mozambique ⁸. While the nation’s nascent industrial base is ill-equipped for high-value active pharmaceutical ingredient (API) production, the RoO could incentivise regional partnerships. Mozambique could focus on secondary manufacturing—formulation and packaging—using APIs sourced from industrialising African partners, aligning with AfCFTA objectives of export diversification ^2,20. The development of such value chains, however, is a medium-term prospect requiring significant investment and technology transfer, factors influenced by the broader intellectual property (IP) landscape.

The evaluation of intellectual property provisions within the AfCFTA framework is therefore critical ⁹. The agreement explicitly recognises flexibilities under the World Trade Organisation’s TRIPS Agreement, a crucial safeguard ¹⁰. For Mozambique, which faces a high burden of communicable and non-communicable diseases, maintaining policy space to utilise compulsory licensing is paramount. The assessment indicates the AfCFTA does not erect new IP barriers beyond TRIPS, but its success in fostering technology transfer depends on national policy agility ¹⁵. Mozambique must proactively design domestic IP and industrial policies to leverage the agreement’s market size, while vigorously defending TRIPS flexibilities in future negotiations ²³.

Building upon these structural analyses, a forward-looking assessment must project impacts on medicine prices and availability ¹². The reduction of tariffs should, ceteris paribus, lower import costs ((Kessy, 2024)). However, the net effect on consumer prices is mediated by other factors including exchange rate volatility, the market power of distributors, and the capacity of national regulatory authorities ^19,25. The creation of a continental market is projected to increase competition, exerting downward pressure on prices for generic medicines where several African producers exist ¹⁷. For novel patented technologies, however, the price impact may be muted without robust national procurement policies. The experience of other blocs underscores that liberalisation must be accompanied by strong regional quality infrastructure and harmonised regulatory standards to realise public health benefits—a significant undertaking for the AfCFTA ^16,24.

Ultimately, this assessment reveals the AfCFTA as a structural parameter that reconfigures opportunities and risks ¹⁴. The tariff phase-outs, Rules of Origin, and IP safeguards create a potential pathway towards improved medicine security ((Kyereboah-Coleman et al., 2025)). Yet, realising this potential is contingent upon deliberate national policy actions to manage fiscal transitions, attract investment, safeguard public health flexibilities, and strengthen regulatory systems ^3,18. The quantitative and qualitative manifestations of these interactions form the empirical basis for the subsequent analysis.

Results (Policy Data)

The analysis of policy data pertaining to the AfCFTA’s pharmaceutical and health technology protocols reveals a complex and evolving landscape for Mozambique, characterised by potential gains in affordability, significant regulatory shifts, and persistent structural challenges for domestic industrial policy ((Mahaluca et al., 2025)). The primary anticipated outcome is a progressive reduction in import duties on essential medicines and medical inputs, rooted in the agreement’s core tariff liberalisation schedules ¹. For a nation heavily reliant on pharmaceutical imports, this phased elimination of tariffs presents a direct mechanism for lowering the landed cost of these commodities ⁶. The resultant cost reductions are expected to marginally improve fiscal space for central medical procurements and potentially lower consumer prices ¹². However, this policy shift interacts with Mozambique’s existing commitments under other trade frameworks, creating a layered and sometimes contradictory policy environment that requires careful navigation ²².

Concurrently, the AfCFTA exerts substantial pressure for regulatory harmonisation, a secondary but profound result ((Mangeni & Mold, 2024)). The establishment of the African Medicines Agency (AMA) creates a new axis of governance alongside Mozambique’s National Directorate of Pharmacy (DNF), signalling a transition from a purely national regulatory paradigm to one influenced by Pan-African standards ³. As Klasen (2025) argues in the context of policy trilemmas, such harmonisation seeks to balance sovereignty with the efficiency gains of integrated markets. For pharmaceutical access, this promises to streamline the registration of medicines sourced from other African manufacturing hubs, reducing duplication and accelerating market entry ⁴. However, it also imposes new capacity demands on Mozambican regulatory authorities, who must adapt their processes to engage effectively with this supranational framework ¹³.

Despite these facilitative mechanisms for trade, the policy data underscores a third, less favourable result: the persistent and potentially exacerbated barriers facing Mozambique’s nascent local pharmaceutical manufacturing sector ((Nzero & Ncube, 2025)). Tariff reduction is a double-edged sword; while lowering costs for imports, it also reduces the protective margin for local industries during their development phase ⁸. The competitive pressure from established producers in North and South Africa, who benefit from economies of scale, is a significant concern ². Furthermore, the non-tariff barriers (NTBs) crucial for local manufacturers—such as complex customs procedures and restrictive standards—remain stubbornly high. The work of Turkson (2024) on non-tariff measures finds analogous challenges in other sectors, suggesting their elimination is politically and technically arduous. For a Mozambican firm, the cost of complying with diverse regulatory requirements across multiple markets may still outweigh the benefits of preferential tariffs, thereby limiting industrial development opportunities ¹⁰.

This tripartite set of results is further mediated by cross-cutting issues. The imperative for technology transfer and regional value chains in pharmaceuticals remains largely aspirational, given the high technological and capital-intensive entry barriers for advanced medical production ¹⁴. Moreover, the intersection of trade policy with public health emergencies informs critical protocols on intellectual property. Mozambique’s position will be shaped by ongoing continental negotiations, such as those surrounding TRIPS flexibilities within the AfCFTA context, which are critical for accessing generic medicines ^17,18. Ultimately, the results depict a policy environment where gains in access through trade liberalisation are tangible but incremental, while the structural transformations required for sustainable health security face a longer and more uncertain trajectory ⁵.

Implementation Challenges

The successful realisation of the AfCFTA’s potential for enhancing pharmaceutical access in Mozambique is contingent upon overcoming profound, interconnected implementation challenges rooted in structural and economic realities. These hurdles threaten to dilute the agreement’s benefits and, without intervention, perpetuate market inequities ^3,13. A primary constraint is Mozambique’s strained administrative and institutional capacity, particularly within customs and standards agencies. Effective continental trade demands sophisticated systems for rules of origin, sanitary measures, and technical standards compliance ⁴. Mozambique’s under-resourced regulatory infrastructure risks undermining tariff liberalisation through bureaucratic inefficiency and a limited ability to police substandard medicines, a critical concern for health security ^10,18. As analyses confirm, the benefits of tariff reduction are negated if procedural complexities at borders persist ⁷.

This administrative challenge is compounded by acute fiscal pressures. The Mozambican state relies on trade tariffs for significant revenue, and their phased elimination on medical goods presents a tangible threat to fiscal space ^8,20. This loss could directly reduce public health financing, creating a paradox where improved trade access coincides with diminished government procurement capacity ². Compensating for this requires broadening the tax base—a complex undertaking in an economy with a large informal sector ²¹.

Persistent non-tariff barriers (NTBs) represent a further formidable obstacle. Evidence indicates that border delays, opaque procedures, and rent-seeking severely hamper the movement of goods ^5,12. For time-sensitive pharmaceuticals, protracted clearance is a direct threat to product efficacy and patient safety. Corruption at border posts could distort the AfCFTA’s benefits, privileging well-connected traders and potentially allowing unsafe commodities to bypass scrutiny ^15,23. The agreement’s success will thus be measured by tangible improvements in these operational realities ¹⁹.

Furthermore, Mozambique’s domestic pharmaceutical manufacturing sector faces acute competitiveness challenges against established producers in nations such as Kenya and South Africa. The AfCFTA is likely to spur specialisation and economies of scale, consolidating production in existing industrial hubs ^14,17. Mozambique’s nascent industry may struggle to compete with larger, technologically advanced firms, risking a flood of imports that could undermine local production and long-term supply chain sovereignty ^6,9. This dynamic mirrors concerns in other sectors, such as agriculture, where similar competitive pressures are anticipated ¹⁶.

Finally, integrating trade policy with other continental priorities creates a complex policy environment. The imperative to boost intra-African trade must be balanced against climate commitments, as the carbon footprint of increased transportation cannot be ignored ^25,22. Moreover, the AfCFTA’s model of developmental regionalism assumes a level of policy coherence difficult to achieve in practice ¹. For Mozambique, aligning health technology, industrial strategy, and trade compliance requires a whole-of-government approach that has historically been elusive ²⁴. These multifaceted challenges underscore that the pathway from signature to impact is fraught with difficulties demanding proactive, context-specific policy responses.

Policy Recommendations

Based on the preceding analysis, Mozambique must adopt a strategically nuanced policy stance to harness the AfCFTA for pharmaceutical access while mitigating its risks. This requires an active, intelligent engagement with the agreement’s provisions, constructing a complementary domestic policy framework that prioritises public health through a tripartite strategy focusing on industrial policy, regulatory harmonisation, and evidence-based procurement.

Firstly, Mozambique must strategically utilise the AfCFTA’s built-in safeguards and flexibilities to nurture its nascent pharmaceutical manufacturing sector. The nation should formally designate essential medicines and health technologies as a strategic sector, invoking temporary safeguards permitted under the Protocol on Trade in Goods to shield local production from premature import competition ²². This facilitates a phased integration allowing local firms to achieve economies of scale, a transitional approach evidenced in other integration contexts ⁷. Concurrent investment policy should attract foreign direct investment into local formulation, packaging, and active pharmaceutical ingredient (API) production, linked to enforceable technology transfer and local staff training commitments ^8,20. This integrated industrial policy recognises that a healthier population contributes to the human capital foundational for sustainable AfCFTA gains ^2,14.

Secondly, Mozambique must accelerate regulatory capacity building and harmonisation to address critical non-tariff barriers. Proactively aligning medicines registration, quality control, and pharmacovigilance systems with the emerging African Medicines Agency (AMA) and SADC guidelines is imperative ^4,12. This dual objective strengthens domestic quality assurance while positioning Mozambican products for easier export under pan-African standards ⁵. Sustained investment in inspector training and laboratory upgrades is essential, as regulatory cooperation is a cornerstone for effective integration and for mitigating the public health risks of substandard or falsified medicines ^19,25.

Thirdly, to navigate the anticipated influx of products, Mozambique must establish a proactive Health Technology Assessment (HTA) unit. This evidence-generating body would guide procurement by evaluating the clinical and cost-effectiveness of new health technologies, ensuring increased trade volume translates into rational medicine use and fiscal sustainability ^3,17. The HTA unit’s analyses should also inform national positions on intellectual property and the implementation of TRIPS flexibilities within AfCFTA negotiations, ensuring policy coherence ^15,18.

Finally, these technical measures require a whole-of-government governance mechanism. A permanent inter-ministerial committee—encompassing trade, industry, health, finance, and foreign affairs—is essential to ensure policy coherence, monitor AfCFTA impacts on medicine access, and coordinate safeguard use ^10,13. This committee should also oversee the integration of climate resilience into pharmaceutical supply chains, addressing concurrent threats to health security and infrastructure ^16,21. By adopting this coordinated suite of policies, Mozambique can transition from a passive recipient to an active architect of a trade environment that enhances pharmaceutical access and health system resilience ^6,9.

Discussion

The evidence regarding the AfCFTA’s impact on access to medicines and medical technologies in Mozambique reveals a complex and sometimes contradictory picture, underscoring the agreement's context-dependent outcomes ((Amonoo & Mhlanga, 2025)). A body of research suggests the AfCFTA holds significant potential to improve access by reducing tariffs and streamlining cross-border trade in pharmaceutical products ^22,5. For instance, studies highlight how the agreement could lower costs and enhance supply chain efficiency for essential medicines ¹⁵. This potential is further supported by analyses focusing on complementary frameworks, such as the digitalisation of customs procedures to facilitate smoother trade ¹³ and the alignment of tax policies to support the healthcare sector ¹⁶.

However, this optimistic perspective is not unanimous ((Beckman et al., 2024)). Other research points to substantial structural and contextual barriers that may prevent these theoretical benefits from materialising. For example, studies on monetary union feasibility ²⁵ and the interplay of migration and unemployment ² indicate that broader macroeconomic instability could undermine the predictable trade environment necessary for reliable medicine supply. Crucially, a key gap in the existing literature is the specific examination of how Mozambique’s national regulatory capacity, intellectual property governance, and local manufacturing limitations mediate the AfCFTA’s impact on medical technology access ^6,12. This article directly addresses that gap by analysing these contextual mechanisms.

Furthermore, divergent findings on issues such as competition enforcement ¹⁴ and the effects of climate change on trade infrastructure ⁸ suggest that the net impact of the AfCFTA will be shaped by a confluence of intersecting policies. Therefore, while the agreement provides a crucial framework for enhancing medicine access, its success in Mozambique will ultimately depend on targeted supplementary policies that strengthen health systems, protect public health safeguards, and foster regional industrial cooperation ^3,19.

Conclusion

The African Continental Free Trade Area (AfCFTA) presents a profound, dual-edged opportunity for pharmaceutical access and health technology policy in Mozambique. This analysis, focused on the critical implementation window from 2021 to 2026, concludes that the agreement’s impact will be fundamentally determined by the coherence and proactivity of Mozambique’s domestic policy response. While the AfCFTA framework offers mechanisms to reduce trade costs and diversify supply sources ⁸, its benefits for health are not automatic and risk being eclipsed by unmitigated challenges, including regulatory fragmentation and competitive pressures on nascent local production ^3,10. Consequently, realising improved access to medicines and medical technologies necessitates a deliberate, health-centric national strategy that actively shapes trade outcomes, moving beyond passive reliance on market liberalisation.

The most significant finding is that the AfCFTA’s success in the pharmaceutical sector is inextricably linked to Mozambique’s capacity for coherent institutional preparedness. The agreement’s potential to mitigate drug shortages and lower costs through intra-African trade is substantial, yet it is contingent upon the harmonisation of standards and the reduction of non-tariff barriers, which remain a considerable hurdle ^4,13. Without robust national regulatory agencies capable of engaging in continental harmonisation initiatives and efficiently clearing imported medicines, theoretical gains in market access will not materialise into tangible health benefits ¹⁹. Furthermore, as regional integration experience suggests, smaller economies must ensure their specific interests, such as access to essential medicines, are not subsumed by larger market forces ⁷. This underscores the necessity for Mozambique to treat this period as a critical phase for building administrative and technical capacity, ensuring its health priorities are articulated within AfCFTA negotiations on intellectual property and regulatory cooperation ²³.

From a continental perspective, this case study highlights a central tension within the AfCFTA project: reconciling economic liberalisation with strategic public goods like health. The agreement’s intellectual underpinnings champion market integration for development ²⁴, yet the health sector often requires managed protection and strategic industrial policy ²¹. The analysis affirms that for Mozambique, a balanced approach is imperative. This involves leveraging the agreement to source affordable generics and technologies from regional manufacturing hubs while simultaneously employing legal safeguards within the AfCFTA framework to support its nascent pharmaceutical industry and protect public health flexibilities ^16,18. The policy recommendations arising from this work—such as integrating health impact assessments into trade negotiation positions and fostering regional pooled procurement—are therefore strategic imperatives for aligning trade policy with the right to health ^12,17.

Crucially, this analysis identifies several pivotal areas for future research. The differential impact of the AfCFTA across therapeutic categories requires urgent investigation; the dynamics for essential generic medicines will differ markedly from those for novel biologics or advanced medical devices ^1,2. Further scholarly inquiry is needed to model the specific effects on medicine prices and availability for non-communicable diseases, which represent a growing burden in Mozambique ^5,20. Additionally, the intersection of the AfCFTA with other pressing continental challenges, such as climate change and its impact on health security, presents a complex research frontier ^14,25. Understanding these nuanced dimensions will be essential for crafting resilient, evidence-based health technology policies.

In conclusion, the AfCFTA is a transformative force that will reshape the market for medicines in Mozambique, but its trajectory is not preordained. The period up to 2026 represents a decisive juncture for policymakers to transition from passive anticipation to active stewardship. By constructing an integrated policy framework that strategically harnesses trade liberalisation while fortifying health systems and regulatory sovereignty, Mozambique can ensure the AfCFTA becomes a genuine catalyst for improved pharmaceutical access ^6,9. The nation’s experience will offer critical lessons for the wider African continent on navigating the complex but essential endeavour of making trade work for health.

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