Authored by USP Senior Technical Advisor, Amanda Lewin, Ph.D. and Unitaid Director of Programs, Robert Matiru.
Africa is entering a new era of pharmaceutical manufacturing, but the continued growth of regionally made medicines depends on trust. A Unitaid-funded initiative is helping strengthen African capacity to generate the quality evidence needed to accelerate local production and expand access to medicines.
While Africa still imports most medicines, its push to expand and grow its pharmaceutical sector is no longer aspirational. Clear targets, backed by capital and policy reforms, are creating conditions for the market to grow and thrive.
Just as critical, regulatory systems across Africa are becoming stronger and more aligned, with countries increasingly working together through initiatives like the African Medicines Agency. At the same time, pooled purchasing, in which countries combine their purchasing power to buy medicines together, is creating more predictable demand at scale through initiatives like the African Pooled Procurement Mechanism.
This summer, in advance of key moments like the Extraordinary Summit on African Health Products Manufacturing, the Africa Healthcare Manufacturing Trade Exhibition and Conference (AHMTEC), and the Conference on Public Health in Africa, these forums are an important reminder that as Africa strengthens its pharmaceutical ecosystem, it must also assure quality to build trust and expand trade. A critical way to do this, particularly for generic medicines, is by proving they work just as well as the medicines that are already on the market.
That scientific evidence is known as bioequivalence. It demonstrates that a generic medicine works just as safely and effectively as the brand name product. It helps regulators approve medicines, gives buyers confidence in their quality, and makes it easier for countries to purchase medicines produced across Africa. That confidence is essential for creating stable demand, attracting investment, and supporting the growth of pharmaceutical manufacturing on the continent.
For investors, development finance institutions and finance ministries, bioequivalence is not just a health safeguard – it is a core element of financial risk management.
In many African countries, regulatory gaps in bioequivalence remain a quiet but serious risk undermining efforts to expand manufacturing. Some authorities don’t require these studies; others apply rules unevenly, mandating them for imported generics while exempting local products. This weakens incentives to invest in local research organizations capable of conducting bioequivalence studies. This inconsistency undermines confidence in locally made generic medicines, exposes patients to unnecessary risk, and erodes public trust.
Trust operates at multiple levels. Patients need confidence that medicines will work as intended, clinicians must trust the generics they prescribe, and procurers must protect public health and public funds.
Research organizations that can carry out these studies are foundational to building that trust. Without clear, consistent standards for these studies, confidence falters, imported medicines are often seen as more reliable, and regional manufacturers struggle to sell their products in markets where these standards are strictly enforced.
Bioequivalence studies typically cost between US$30,000 and US$300,000, depending on complexity. Limited local research capacity forces many manufacturers to outsource studies to India or elsewhere, driving up costs.
Currently, only a handful of research entities are capable of conducting these studies in Africa. Although the generic industry is expanding, many organizations still struggle to build and sustain business.
Aligning goals with action
Africa urgently needs to build the capacity to generate this critical evidence on the continent. As manufacturing capabilities are strengthened across the continent, more countries are expected to require bioequivalence studies for generic medicines, making local capacity increasingly important. Unitaid and USP are also helping make that happen by strengthening African research organizations and the systems that support them.
We are supporting four Africa-based research organizations across the continent to strengthen the expertise, systems and infrastructure needed to conduct high-quality studies. In some cases, this involves helping organizations build the clinical and laboratory capabilities needed to conduct these research studies. In other cases we support more established organizations to work together as networks to make studies more affordable and efficient.
Africa is steadily building the talent, demand, and political momentum needed for a strong pharmaceutical manufacturing base. The next challenge is ensuring that medicines produced on the continent consistently instill trust as they reach their patients at scale.
As stakeholders across the continent work to build lasting industries, they must recognize bioequivalence for what it truly is: an opportunity to bridge quality, credibility, and investment – and a shared priority for governments, regulators, manufacturers, investors, and other partners alike.
For a more detailed technical perspective on strengthening bioequivalence capacity in Africa, read our partner USP’s accompanying blog.