Progress, Work in Progress and What's Missing as Africa's Regulatory Environment Matures

Africa’s health sector is undergoing a period of rapid transformation in the field of medicines regulation. If progress made in 2024 is anything to go by, 2025 promises further acceleration of the region’s regulatory development across the continent. The beneficiaries of this progress is patient safety on the continent. While much progress has been made in improving the safety, efficacy, and quality of medicines across the continent, a critical gap remains: the regulation of medical devices, including in vitro diagnostics (IVDs). These tools, crucial in disease diagnosis, treatment, and prevention. However, they remain significantly underregulated compared to medicines. Yes, the region has made notable strides in certain areas of regulation, but oversight over medical devices and vaccines still significantly lags behind. This highlights the need for comprehensive, integrated regulatory frameworks better equipped at safeguarding patient safety and public health. Regulatory systems play a central role in assuring the quality, safety, and efficacy of medical products of any country.

The promise of patient safety on the continent

In recent years, the Africa region has made significant strides in improving its medicines regulatory systems. Eight countries— Senegal, Zimbabwe, Ghana, Tanzania, Nigeria, Senegal, Egypt and Rwanda —have been confirmed to have a stable, well-functioning and integrated regulatory system, that is, a maturity Level 3 (ML3) system on the WHO global benchmark. The WHO global benchmarking process, is part of WHO’s programme to strengthen regulatory systems. It has been driving Africa’s momentum towards regulatory harmonization and the future operationalization of the African Medicines Agency (AMA). It evaluates core functions such as product authorization, market surveillance and adverse event detection. WHO benchmarking of national authorities means that the WHO has certified that these nations have developed robust frameworks that facilitate the timely approval of pharmaceuticals and the establishment of national regulatory systems that meet international standards.

Pan-African initiatives like the African Medicines Regulatory Harmonization (AMRH) and the Pan African Regulatory Forum (PARF) which aim to streamline the approval process for medicines and ensure better coordination between countries including to keep substandard counterfeited medical products out of African markets have been critical to regulatory progress within the region. For instance, initiatives like Zazibona in the Southern African Development Community, the East African Community (EAC) and the West African Health Organization (WAHO) have successfully established Medicines Regulatory Harmonization programs.

Working to harmonize regulatory practices within regional economic communities has significantly reduced the time it takes to register medicines across member states. This progress contributes towards improving access to medical products of assured quality, that are effective and that work as expected. This is critical to the continent's ability to drive industrial development and capabilities to manufacture essential medical products and to respond to public health challenges, such as the COVID-19 pandemic or the mpox outbreak.

The Glaring Gap and Need for a Bridge - Medical Devices and In Vitro Diagnostics

However, while medicines regulation has been advancing, medical devices, including IVDs, have been left behind. In vitro diagnostics, such as tests for HIV, tuberculosis, malaria, and COVID-19, are vital for early diagnosis and management of diseases. Yet their regulation is often fragmented or entirely absent in many African countries. This lack of regulation puts patient safety and public health at risk from unapproved or substandard and counterfeited diagnostic devices can lead to misdiagnoses, delayed treatments, harm and ultimately, higher morbidity and mortality.

There are several reasons why medical device regulation has lagged behind. One of the main challenges is the lack of specialized regulatory expertise for medical devices within national regulatory authorities to oversee medical devices and IVDs. In addition, many African countries have limited resources to implement comprehensive regulatory systems for all medical products including medical devices. While some countries, like South Africa have made strides in creating regulatory frameworks for medical devices, many others are still in the early stages of development and regulation of medical devices remains in a state of harmful neglect.

A Work in Progress with Great Promise

Another area where Africa faces regulatory challenges is on oversight over vaccine production an area that is critical to the region’s ability to respond to climate-driven acceleration in disease outbreaks that the WHO projects over this decade. While Africa has made significant progress in the regulation of medicines, oversight over vaccine production remains underdeveloped. Most African countries rely on imports for their vaccine needs.

This dependency became particularly apparent during the COVID-19 pandemic, when vaccine access was a major challenge and was again emphasized by the ongoing mpox outbreak. Consequently, Africa’s ambition is to reduce its share of imported vaccines and meet more of what the region’s vaccine needs with vaccine manufactured on the continent. Africa’s dependency is not only confined to vaccines where 99% of the continent’s needs are imported. The region imports more than 90% of medicines and 100% of medical devices and active pharmaceutical ingredients..

Regional efforts are underway to build the capacity for vaccine production in Africa, such as the African Union’s Partnership for African Vaccine Manufacturing (PAVM) whose vision is to manufacture 60% of continental vaccine needs by 2040. Several countries on the continent including Senegal, Morocco and Tunisia have capacity to manufacture vaccines locally. If vaccine production on the African continent becomes sufficient and sustainable, these efforts can lead to significant improvements in access to vaccines during disease outbreaks, ensure security of access and a level of self-sufficiency in vaccine supply.

These efforts however need stronger regulatory support to be truly effective. Of the 45 regulatory systems benchmarked between 2019-2022, 41 were at ML1 or 2, that is operating without a formal approach. Even fewer countries have capacity for good regulatory oversight over vaccine production yet. The region has exactly two countries—South Africa and Egypt—have reached a level of regulatory maturity that allows them to produce and regulate vaccines effectively, at WHO ML3 in oversight over vaccine production. The continent continues to lags behind in vaccine regulation. ?

Going forward—keeping momentum and building bridges

The progress made in medicines regulation across Africa is commendable. However, without a comprehensive approach to regulating all essential medical products that is pharmaceuticals, vaccines, medical devices and blood products, patient safety will continue to be at risk across the continent and the full potential of the advancements made so far will not be fully realized. Therefore, in 2025, progress would benefit from taking stock of how to maintain the gains made in regulatory development and end the neglect of effective regulation of essential products like medical devices, blood products and vaccines.

In order to protect patient safety, the Africa region needs holistic regulatory systems capable of ensuring safe essential medical products. Countries must therefore review their systems and prioritize the development of regulatory frameworks that include medical devices and IVDs to ensure that all aspects of healthcare are adequately controlled and monitored. This includes establishing specialized technical expertise for medical devices and increasing investment in regulatory infrastructure.

In parallel, African nations must continue to strengthen their capabilities in vaccine production and regulatory oversight over vaccine production. By doing so, the continent will not only improve access to safe life-saving medical products of assured quality. It will also pave the way for greater self-reliance in and begin to effectively address the epidemic of substandard counterfeited medical products that is putting patient safety on the African at grave risk. The regulatory environment in Africa is evolving, but much work remains. With a focused effort to evaluate where we are and take steps to bridge existing gaps, the continent can better pave the way towards stronger, more resilient regulatory system that effectively safeguards patient safety.

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