Africa’s ability to protect patients and expand local pharmaceutical manufacturing depends on more than the capacity to produce medicines. It also requires strong regulatory institutions, skilled professionals who can assess medical products, inspect manufacturing facilities, monitor safety and prevent substandard or falsified medicines from reaching patients.
The inaugural African Medicines Agency (AMA) Week in Kigali marked an important institutional milestone, with the World Health Organisation confirming that ten African national regulatory authorities have now attained Maturity Level 3 under its Global Benchmarking Tool. This represents progress towards more reliable medicines oversight and stronger cross-border cooperation, although it does not mean that every medicine sold in those countries has been individually verified or that Africa has achieved pharmaceutical self-sufficiency.
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WHO Maturity Level 3 describes a stable, well-functioning and integrated regulatory system. Its benchmarking framework assesses essential functions such as product registration and marketing authorisation, market surveillance, regulatory inspections, laboratory testing, pharmacovigilance and clinical-trial oversight. However, maturity assessments are tied to specific product categories and regulatory scopes. They should therefore not be interpreted as a blanket guarantee covering every medical product or regulatory function in a country.
The ten African authorities recognised at ML3 include Egypt, Ethiopia, Ghana, Mozambique, Nigeria, Rwanda, Senegal, South Africa, Tanzania and Zimbabwe. Mozambique’s achievement in 2026 expanded the list, while Ethiopia reached the milestone in 2025. The benchmark is an important institutional achievement, but it remains distinct from the WHO Listed Authority designation, which involves a separate assessment of advanced regulatory performance.
The practical value of stronger regulatory systems extends beyond national borders. Medicines and pharmaceutical ingredients move through international supply chains, meaning weaknesses in one market can create risks elsewhere. Greater cooperation allows authorities to exchange safety information, coordinate inspections and rely on assessments conducted by trusted regulators. This can reduce duplication while helping countries maintain appropriate standards for the quality, safety and efficacy of medical products.
For manufacturers, more aligned regulatory procedures can also reduce the time and cost of seeking product authorisation across multiple markets. This is particularly important for Africa’s pharmaceutical industry, which remains heavily dependent on imported medicines. UN Trade and Development estimates that more than 70% of pharmaceuticals consumed on the continent are imported, while the African pharmaceutical market is valued at tens of billions of dollars.
Regulation is therefore also an industrial policy tool. Local pharmaceutical production cannot expand sustainably without predictable requirements for licensing, quality assurance, inspections and product approval. The objective is not to weaken oversight in the interest of industrial growth, but to develop regulatory systems that protect patients while enabling compliant manufacturers to invest, improve production and compete across regional markets.
The AMA’s structural challenge, however, remains participation. As of October 2026, only 33 of the African Union’s 55 member states had ratified the AMA Treaty, leaving 22 yet to join the framework. The agency’s ability to advance regulatory harmonisation across the continent will depend partly on broader participation and the willingness of member states to cooperate in practice.
The Kigali meeting sought to strengthen this institutional foundation. A major development was the inauguration of seven AMA technical committees, covering areas including medicines and vaccines evaluation, clinical-trial oversight, inspections, vigilance and medical devices. The event also saw the launch of the Regulatory Innovation and Manufacturing Readiness Hub and the Capacity Strengthening Hub, intended to provide technical support, strengthen regulatory expertise and encourage local pharmaceutical manufacturing.
These initiatives build on the framework agreement between WHO and AMA signed in May 2026, alongside a five-year joint operational plan. Their effectiveness will depend on sustained political and financial support, capable national institutions and practical cooperation among participating countries. Ratification alone will not deliver harmonisation if regulators lack the resources, technical expertise and information-sharing arrangements needed to implement common approaches.
An ML3 rating is an institutional benchmark, not a measure of whether medicines are affordable or available in clinics. A regulator may authorise a quality-assured treatment, but patients can still lack access if procurement is delayed, distribution networks fail or household costs remain prohibitive. Conversely, faster approval without adequate scrutiny can expose patients to serious risks. Governments should therefore monitor indicators such as review times, inspection coverage, safety-alert response and essential-medicine availability alongside regulatory maturity.
The broader lesson from AMA Week is that patient protection, regional cooperation and industrial development are interconnected priorities. Stronger regulatory institutions can help African countries improve public health safeguards while creating a more predictable environment for pharmaceutical investment. However, the milestone of ten ML3 authorities will matter most if it leads to sustained capacity-building, wider treaty ratification and practical cross-border cooperation that makes quality-assured medicines more accessible to the people who need them.
