AU picks daunting target for local pharma production

A key focus of the declaration is creating predictable demand for manufacturers through pooled procurement and long-term offtake arrangements.

However, to scale, local pharmaceutical companies need financing, regulatory approvals, quality checks, clinical trials and reliable cross-border logistics and sales.

Pharmaceutical manufacturing is capital intensive. Facilities, equipment, validation and skilled workforce development require large upfront investment with slow returns. Many African manufacturers lack access to long-term, patient capital needed for industrial scale. While the declaration mentions a pooled procurement capital fund, it does not clarify financing size or risk-sharing mechanisms necessary to make large-scale manufacturing commercially viable.

Pharmaceutical companies must register products country by country, each with different rules and technical requirements. This slows market entry and raises costs. A drug approved in one African country is not automatically accepted in another. The declaration supports harmonisation in principle, but it does not yet solve the operational delays and uncertainty manufacturers face when scaling across fragmented regulatory systems.

The World Health Organization  prequalification is a global quality certification showing a medicine meets safety and manufacturing standards for international procurement. Without it, suppliers struggle to sell to major buyers and donor-funded programmes, who are common buyers in Africa. Achieving this status requires strict compliance and documentation systems. The declaration does not directly address the technical and financial burden firms face reaching prequalification-level.

Scaling pharmaceutical production requires clinical trials and regulatory-grade research systems. Many African manufacturers depend on external data or licensed formulations, which limits innovation and slows approvals. Currently, just 4% of clinical trials take place in Africa. However, the declaration gives less operational detail on strengthening clinical research ecosystems that validate products for both local and global markets.

Even local manufacturers rely heavily on imported active pharmaceutical ingredients (APIs) and other raw materials. Africa imports over 95% of its active pharmaceutical ingredients, mainly from India and China. This exposes production to currency fluctuations, shortages and high input costs. The declaration emphasises local production targets, but does not yet outline a concrete strategy for regional API production or supply chain localisation.

Local production alone is not enough; medicines must move efficiently across borders. Africa’s new continental warehouse is a positive step, but reliable cold chains, transport networks and cross-border customs alignment remain gaps. Without coordinated logistics, stock may sit unused in one country while shortages persist elsewhere, limiting the impact of local manufacturing at scale.

Manufacturing does not guarantee market uptake. Multinational pharma firms like Roche and Pfizer invest heavily in large, experienced sales teams across African markets. Local manufacturers lack comparable commercial reach, which limits hospital adoption and brand trust. Building and retaining such sales networks is costly and the declaration’s focus on pooled procurement does not fully address this commercial capacity gap.

The AU declaration is great. But all the hard work is yet to be done. Africa has never had a continental-level manufacturing commitment like this before. For the first time, governments have coordinated support for local producers. 

That creates a real foundation for long-term industrial growth, a turning point that if well implemented, could finally move African pharma to a stable reality.