Medicines for Africa I The Role of WHO Maturity Benchmarking in Improving African Medicines Regulatory Agencies I Lenias Hwenda

Author I Lenias Hwenda

In its efforts to promote universal health coverage and access to safe, effective, quality, and affordable medicines and vaccines, the World Health Organization (WHO) has developed a robust framework to evaluate the performance of National Regulatory Agencies (NRAs) worldwide to help them improve them. This initiative, known as WHO maturity benchmarking, is pivotal in ensuring that medicines, vaccines, and medical devices meet international standards. Its purpose is to safeguard public health, improve trust in healthcare products and ensure the safety of patents. This initiative has a critical role to play in enabling African medicines regulatory agencies to attain higher levels of regulatory maturity.

Understanding WHO Maturity Benchmarking

Regulatory maturity benchmarking by the WHO uses the Global Benchmarking Tool (GBT), a comprehensive evaluation mechanism that assesses the regulatory capabilities of NRAs across approximately 268 sub-indicators. These indicators span across nine thematic areas that include clinical trial oversight, marketing authorization, and quality management systems, to name a few. The GBT framework categorizes NRAs into four maturity levels (ML), where the lowest level of maturity, ML1 signifies the existence of some regulatory elements and the highest ML4 represents an advanced level of performance with continuous improvement.

What is the Significance of Regulatory Maturity Levels?

• Maturity Level 1 (ML1): Indicates the nascent stage of a regulatory system with basic regulatory functions in place.
• Maturity Level 2 (ML2): Denotes an evolving regulatory system that partially performs essential regulatory functions.
• Maturity Level 3 (ML3): Reflects a stable, well-functioning, and integrated regulatory system capable of effective oversight and quality assurance.
• Maturity Level 4 (ML4): The pinnacle of regulatory achievement, indicating an advanced and continuously improving regulatory system that sets global standards.

Africa's Medicines Regulatory Landscape

In Africa, a continent with 54 countries, that are facing a grave threat of counterfeited medical products the need for robust regulatory systems is paramount to ensure access to quality healthcare products and patient safety. However, the African regulatory environment is still maturing and the distribution of NRAs performing at higher maturity is still limited. The continent has 3 regulators functioning at Maturity Level 3 for medicines that is Tanzania, Ghana and Nigeria and two functioning at Maturity Level 3 for vaccines that is Egypt, South Africa, and Nigeria for imported vaccines.

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This means that 95% of NRAs function at ML2 or below and the same is true for vaccines. A significant portion of African countries' NRAs operating at the basic level of ML1 highlights a foundational regulatory presence but with substantial room for improvement. A smaller percentage of countries have evolved to ML2 showing progress in regulatory functions but still lacking full functionality. A small fraction of Africa’s NRAs notably specifically, Tanzania, Ghana, Nigeria, and Egypt have been recognized for reaching ML3 for either vaccines or medicines highlighting their effective regulatory systems for medicines in the case of Tanzania, Ghana and Nigeria and vaccines for South Africa, Egypt and Nigeria (imports only). Notably, fewer than 30% of the world's regulatory authorities, including those in Africa, achieve this functional and integrated system status. There is no available data for the level of maturity for medical devices on the African continent and it is assumed that none of the agencies on the continent have achieved ML3.

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Spotlight on ML3 Achievers in Africa

The National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria was recently elevated to ML3 for medicines and imported vaccines marking NAFDAC as a stable and well-functioning regulatory body. Nigeria's benchmarking covered a broad spectrum of regulatory functions but its ML3 rating for medicines and imported vaccines excluded lot release for locally manufactured vaccines. Tanzania and Ghana FDA has also achieved ML3 for medicines. South Africa's Health Products Regulatory Authority (SAHPRA) also stands out, having attained ML3 for vaccine regulation, but not medicines alongside Egypt. These achievements place Nigeria, Ghana and Tanzania on the path to becoming a WHO Listed Authorities, joining a prestigious group of global reference regulators. ML3 for vaccine regulation places Egypt and South Africa as leaders in vaccine regulation in the region that is significant in their role in manufacturing and distributing vaccines.

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How does Africa's Regulatory Maturity Compare with that of India and China where most of its medicines are sourced

The majority of medicines consumed on the African come from India and China - two major players in the global healthcare product market. Both have also been evaluated using the WHO GBT and after a comprehensive assessment and efforts to improve India achieved a functional level in vaccine regulation, with a mix of ML3 and ML4 ratings across various regulatory functions. China's vaccine regulatory system was also confirmed at ML3, affirming its stable and integrated regulatory framework, a testament to the country's commitment to quality and safety in vaccine production and distribution. It is notable that India and China are at the same level of maturity for vaccines as South Africa, Egypt and Nigeria as they are all ranked at ML3, in the case of Nigeria for vaccine imports only. India and China however, do not have ML3 ranking for medicines and therefore are considered lower than Ghana, Nigeria and Tanzania.

Conclusion

In conclusion the WHO maturity benchmarking initiative is a critical tool in the global effort to ensure that all individuals have access to safe, effective, and quality health products. It is also critical in the assessment of where international mechanisms are buying medical products. It is noteworthy that international mechanism are willing to buy medical products from India and China which both of which have lower regulatory maturity ranking compared to Ghana, Nigeria and Tanzania, but have typically shunned buying medical products made on the African continent. The progress of regulatory agencies in Africa, India, and China underscores the importance of continuous improvement and international cooperation in health product regulation. As more countries strive to reach higher maturity levels, the global community moves closer to achieving universal health coverage and safeguarding public health. Medicines for Africa calls on African countries in particular to double their efforts to improve their regulatory maturity as a critical defense against counterfeited medical products and their impact on African patients.

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