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Leveraging South Africa’s maturity level 3 to strengthen regulatory systems in the Africa region: What is next?

The establishment of the African Medicines Agency will significantly contribute to the improvement of healthcare delivery across the continent and better overall health of African citizens.


Africa continues to be a growing continent in many aspects. It is expected that the population of young Africans will constitute 42% of global youth by 2030. As the continent’s population grows, the pharmaceutical manufacturing industry is also growing at an unprecedented rate, surging from $19-billion (about R360-billion) in 2012 to a monumental $66-billion (about R1.2-trillion) by 2022

Currently, Africa accounts for only 3% of global pharmaceutical manufacturing and about 70-80% of medicines in sub-Saharan Africa are imported. The attainment of health security including stronger health systems and the ability to protect itself in the event of pandemics is of critical importance for the continent. 

According to the African Development Bank, Africa spends as much as $14-billion (about R265-billion) annually on importing more than 70% of the medicines it needs. As the pharmaceutical manufacturing industry grows, it is equally important to ensure that our people receive medicines and medical products that are safe and efficacious and that investments are made towards strengthening national and regional regulatory authorities for them to effectively execute their functions. Secondly, as products cross borders, it is equally important to ensure regulatory harmonisation across the regions.

Whilst a lot of progress has been made to ensure safety of medicines, the continent continues to have substandard and falsified medicines in circulation. In 2022, the Gambia lost 66 children, and an investigation by the United States Centres for Disease Control and Prevention “strongly suggests” that medicines contaminated with toxins, imported into Gambia, led to the cluster of acute kidney injury among 78 children, most of whom were aged under two years. Since the deaths in Gambia, there have been reports of 201 children who died in Indonesia, and 19 in Uzbekistan, linked to different manufacturers’ contaminated cough syrups.

With all the challenges that are confronting the continent with regards to limited local manufacturing, inadequate regulatory systems and limited access to quality and safe medicines, there are several great strides that the continent continues to take towards establishing lasting capabilities and solutions. These include continental initiatives aimed at having strengthened, harmonised and coordinated regulation of medical products, through the establishment of the African Medicines Agency (Ama).

In February 2019, the African Union (AU) adopted the treaty for the establishment of Ama and the treaty came into force on 5 November 2021, 30 days after the 15th AU member state deposited its instrument of ratification. Currently, there are 27 African Union member states that have ratified the treaty. 

The establishment of Ama will significantly contribute to the improvement of healthcare delivery across the continent and better overall health of African citizens as envisioned in Africa’s Agenda 2063. Ama will provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa and will enhance Africa’s capacity to regulate medical products and technologies to improve access to quality, safe and efficacious medical products on the continent. 

Effective implementation of harmonised regulatory requirements across the continent, through Ama and the regional economic communities (RECS) will go a long way in supporting the growth of local pharmaceutical production and will play a critical role in catalysing trade in support of the African Continental Free Trade Area (AfCFTA), which will integrate 1.3-billion people and potentially 2.2-billion people by 2050.

Whilst regulatory harmonisation efforts have been put in place as early as 2009 when the African Medicines Regulatory Harmonisation (AMRH) programme was established as a response to addressing challenges faced by national medicine regulatory authorities (NMRAs) in Africa and to facilitate harmonisation in the regional economic communities, Ama will build on these efforts to facilitate collaboration and harmonisation among the 55 African Union member states. Through a harmonised and collaborative review mechanism, Ama will enable efficient regulatory review pathways which will result in improved ease of movement of medical products that meet accepted international standards, promote local production, encourage innovation, and ease introduction into the African market. All these efforts will ensure that products regulated within member states and across the continent are of the highest quality and are safe and efficacious.

The African Union Development Agency (Auda-Nepad) is amongst the African Union agencies that are closely supporting Ama and regulatory harmonisation initiatives with the RECs and national regulatory authorities. As efforts to operationalise Ama are underway, Auda-Nepad is already working with national regulatory authorities and RECs to assess, initially, 30 different products as part of the pilot continental review process. The South African Health Products Regulatory Authority (Sahpra), which is amongst the most advanced regulatory authorities in the continent is providing a platform that Auda-Nepad will be using for the assessment of the products.

Sahpra has made significant strides in establishing itself as a recognised and reputable national regulatory authority on the continent. Collaborations with other regulatory authorities and deliberate capacity building and growth has yielded great results for Sahpra and also benefits the South African populace and the continent. 

In October 2022, the World Health Organisation (WHO) announced that the South African Health Products Regulatory Authority had attained WHO maturity level 3 (ML3) for vaccine production) — the third of four levels in the WHO’s classification. Maturity level four (ML4) is the highest. As a fairly new instituted independent regulatory authority, this is indeed a noteworthy accolade for Sahpra.

This means that Sahpra has a stable, well-functioning, and integrated regulatory system to ensure the quality, safety, and efficacy of vaccines registered by Sahpra. It also places Sahpra amongst the first two African countries to attain such status for vaccines and amongst the top 5 national medicines regulatory authorities on the African continent to attain ML3. The national regulator now has a target of attaining maturity level 4.

Sahpra and the National Control lab must be commended for reaching ML4 for the Lot Release function. This function is critical in ensuring that the vaccines made available in the country meet the highest quality requirements. ML4 represents a regulatory function that is advanced, well-functioning and is continuously improving. To put in context, this status compares to that of the US and Singapore as examples. As Sahpra builds towards attaining WHO ML4, it will continue to collaborate with other national regulatory authorities, international partners, and stakeholders to build its capacity and strengthen its regulatory frameworks.

In August this year Sahpra was designated as a Regional Centre of Regulatory Excellence (RCORE) for Vaccines Regulatory Oversight for the next 4 years. This means that as a well-resourced regulator, South Africa will be supporting continent-wide regulatory systems strengthening and will be leading in areas such as market authorisation, surveillance, and control of vaccines. RCOREs support regulatory workforce strengthening through training in regulatory functions and enhance skills through hands-on training and exchange programmes amongst national medicines regulatory authorities.

Boitumelo Semete-Makokotlela is the chief executive officer at the South African Health Products Regulatory Authority (Sahpra).

Chimwemwe Chamdimba is the head of African medicines regulatory harmonisation at the African Union Development Agency (Auda-Nepad).