Effective regulatory systems play a critical role in assuring the quality, safety, and effectiveness of medical products, and are fundamental to national health systems.
The development of robust and effective National Medicines Regulatory Authorities (NMRAs) is therefore an essential requirement for the development of a sustainable vaccine manufacturing industry in Africa.
The Africa CDC’s ambitious target of manufacturing 60% of Africa’s routine vaccine needs by 2040 requires capable NMRAs with at least WHO maturity level three (ML3) status. NMRAs with ML3 status will enable African vaccine manufacturers to achieve World Health Organization prequalification (WHO PQ)- a global standard to ensure vaccines are safe and properly produced.
As part of the five-step program created by the WHO to increase the capacity of NMRAs, the WHO uses a Global Benchmarking Tool (GBT) to evaluate regulatory systems and to define the Maturity Levels (MLs) of NMRAs using a range from level 1-4.
Levels 1 and 2 represent NMRAs that are nascent and can only partially perform essential regulatory functions. ML3 is the mark of a stable, well-functioning, and integrated regulatory system. While ML4 refers to NMRAs operating at advanced levels of performance and continuous improvement.
The capacity of African NMRAs is hampered by the shortage of personnel to perform critical regulatory functions, including insufficient qualified assessors and inspectors
Unfortunately, most African NMRAs operate at levels 1 and 2 and currently, only five NMRAs in Africa; Tanzania, Ghana, Nigeria, Egypt, and South Africa have achieved a maturity level 3 (ML3) rating. Sustainable vaccine manufacturing in Africa demands that the capacity of African NMRAs must be strengthened to reach ML3.
Only then can they provide the required vaccine approvals and ongoing oversight for continued regulatory compliance that are prerequisites for local vaccine manufacturers to submit applications for WHO PQ.
Challenges confronting NMRAs in Africa
Although the past year has seen African NMRAs actively working towards improving their level of maturity, they continue to face obstacles across all maturity levels. One major challenge is insufficient funding, as many remain over-dependent on government funding and lack any kind of sustainable self-financing mechanisms. African NMRAs also face policy constraints and the lack of an efficient and common medicines regulatory framework.
Another important factor is the limited expertise and insufficient human resources. The capacity of African NMRAs is hampered by the shortage of personnel to perform critical regulatory functions, including insufficient qualified assessors and inspectors. Training is inadequate for the few available staff, and it can be difficult to hire more qualified people locally. Political instability also contributes to the uncertainty NMRAs face, making planning difficult and progress slow.
However, efforts made by African NMRAs to improve their capacity and the progress achieved so far, suggests that more NMRAs will reach ML3 status within the next few years.
Strategies to strengthen African NMRAs for local vaccine manufacturing
Key strategies to strengthen African NMRAs for sustainable local vaccine manufacturing include:
1. Supporting the operationalization of the African Medicines Agency (AMA): Various initiatives, particularly the African Medicines Regulatory Harmonization Program (AMRH) and the African Medicines Agency (AMA) are currently ongoing on the continent to support NMRAs in their regulatory responsibilities. The AMA was established in 2021 and is seen as the progressive next step towards the harmonization of regulations across Africa.
Advocacy is therefore needed to align the priorities of government and stakeholders in favour of the operationalization of AMA for the harmonization of vaccine manufacturing regulatory activities. When it becomes operational, the AMA is expected to work collaboratively with NMRAs to facilitate coordination of regional harmonisation efforts, provide technical guidance, and reduce duplication of efforts, ensuring cost-effective use of the scarce resources and sustainability.
2. Leveraging the role of Partnerships for African Vaccine Manufacturing (PAVM): The African Union and Africa CDC launched Partnerships for African Vaccine Manufacturing (PAVM) for the sustainable development of Africa’s vaccine industry. PAVM will collaborate with AMA and AMRH to create a harmonized regulatory ecosystem for vaccines, including supporting the migration of priority NMRAs to ML3.
This will involve supporting the harmonization of NMRAs’ operating models with standardized processes (such as, by creating an emergency regulatory approval process for outbreak vaccines), as well as tools and documentation that will enhance collaboration, patient safety, and health outcomes.
3. Training of regulatory personnel and skills development: Global partnership and collaboration is required to fill critical knowledge gaps through technologies and know-how transfer to create a critical mass of regulatory experts whose expertise and competencies can match key regulatory functions. To achieve this, Bloom Public Health has partnered with Biotech Training Facility, Netherlands, to establish the African Vaccine Academy (AVA).
Read also: African Vaccine Academy: Building local talent for sustainable vaccine manufacturing
The AVA is an African-wide initiative that will provide world-class online and hands-on training for regulators, quality assurance officers (QA), and other relevant professionals to strengthen Africa’s vaccine manufacturing capacity. African NMRAs should also take advantage of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) membership to build the capacity of its inspectors as promoted by the Africa-wide PIC/S Initiative.
In conclusion, NMRAs play a key role in achieving the Africa CDC’s 2040 vision for local vaccine manufacturing. More support is therefore required to improve coordination between governments, funders, and regulatory bodies to overcome the bottlenecks confronting African NMRAs and to create a sustainable regulatory ecosystem on the continent.