The decision by the African Medicines Agency (AMA) to prioritise establishing structured support for small and medium-sized pharmaceutical manufacturers and innovators is potentially a highly consequential one for how the continent approaches health, industry, economic development and security.
The proposed creation by the agency of an SME & Innovation Office reflects a hard-headed recognition that pharmaceutical production is strategic infrastructure, one that no region serious about resilience and sustainability can afford to outsource indefinitely.
According to AMA director-general Delese Mimi Darko, “The innovation and SME office will be an enabler of business. Africa’s ambition is to manufacture a significant proportion of its vaccine by 2040 and the SME office will provide targeted support for that and other products that could be in scope, such as highly innovative medicines.”
For too long Africa’s pharmaceutical ecosystem has been shaped by dependency. Essential medicines are largely imported. Supply chains stretch across continents. Medicine availability is vulnerable to shocks far beyond the control of national health systems. The Covid-19 pandemic, followed closely by geopolitical disruptions and trade constraints, exposed the risks of this model with painful clarity. Shortages were not an exception. They became the norm. Prices rose. Procurement stalled. Informal markets expanded to fill the gaps, leaving patient safety exposed.
Industrial strategy anchored in healthcare
Against this backdrop, the AMA’s strategic consideration is best understood as more than a regulatory reform. It is an industrial strategy anchored in health and economic security. By offering co-ordinated, predictable and continent-wide support to manufacturers and innovators, the agency is addressing one of the most persistent obstacles to local production businesses. Fragmentation, multiple regulatory regimes, inconsistent standards and opaque approval processes. These factors have long discouraged investment and limited scale. A centralised framework that actively supports compliance and innovation lowers these barriers and signals commitment to both local and international investors.
This approach is neither radical nor untested. It closely mirrors the path taken by advanced economies that recognised early on that pharmaceutical capacity is too important to leave to market forces alone. In Europe, the European Medicines Agency established a dedicated SME Office. It provides administrative and strategic support including scientific advice, regulatory guidance and tailored support to smaller manufacturers.
This approach is neither radical nor untested. It closely mirrors the path taken by advanced economies that recognised early on that pharmaceutical capacity is too important to leave to market forces alone.
Registered SMEs can benefit from financial incentives such as reduced fees for scientific advice and inspections or fee deferrals for marketing authorisation applications, even fee exemptions in certain cases. It even provides workshops and trainings, keeping SMEs informed with critical information.
The objective was to strengthen Europe’s pharmaceutical base, encourage innovation and reduce dependency on external suppliers. The result has been a more resilient and competitive industry, capable of responding quickly to public health needs.
In the US the Food & Drug Administration (FDA) has long viewed pharmaceutical innovation as a matter of national interest. The FDA actively enables manufacturers to navigate complex approval processes without compromising safety through structured early engagement, clear development pathways and regulatory science support.
Canada has taken a similar stance, embedding industry support within Health Canada to reinforce domestic manufacturing and innovation capacity. In all three cases regulators understood that safeguarding public health and enabling industrial growth are not opposing goals. They are mutually reinforcing ones.
Africa’s circumstances make this logic even more compelling. Local production shortens supply chains and reduces exposure to external shocks. It also improves oversight across the value chain. At the same time it creates skilled jobs, builds technical capacity and retains economic value within the continent. Most importantly, it stabilises availability of medicines. When medicines are consistently accessible and affordable, unsafe alternatives lose their market appeal. This strengthens both patient safety and system credibility.
The most effective way to reduce the circulation of unsafe medicines is to make them unnecessary.
The AMA’s focus on SMEs and innovators is particularly consequential. Smaller manufacturers are often the most agile and best positioned to respond to local health needs. Yet they are also the most constrained by regulatory complexity and limited access to capital and regulatory support. Structured support — clear guidance, harmonised standards and predictable timelines — can unlock investment and enable these enterprises to scale. This is how industrial ecosystems are built. Not through protectionism but through intelligent regulation that lowers risk and rewards compliance.
Health and industrial policy alignment
Regulatory support alone is, however, not enough. For this strategy to succeed regulatory reform must be matched by co-ordinated action elsewhere. Governments will need to align health policy with industrial policy. They must treat pharmaceutical manufacturing as critical strategic infrastructure.
Regional procurement mechanisms must provide reliable demand to support scale. Financial institutions must recalibrate their risk assessments to recognise the long-term value of pharmaceutical production. International partners should shift from short-term supply solutions toward meaningful technology transfer and capacity building.
The AMA’s initiative is signalling the continent’s readiness to move beyond emergency responses and towards structural solutions. Law enforcement and public awareness will always have a role in protecting patients. They cannot, however, substitute for reliable supply. The most effective way to reduce the circulation of unsafe medicines is to make them unnecessary.
By backing homegrown pharmaceutical innovation Africa is not only doing what Europe, the US and Canada have already done, it is using regulation as a tool of health and economic security and strategy. AMA is therefore helping lay the foundation for a pharmaceutical sector that serves both public health and long-term development — and for a continent that is no longer defined by vulnerability but by resilience.
• Hwenda is founder and CEO of Medicines for Africa.
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