Strengthening Africa’s Medicines Regulatory Framework is ‘Essential’ for Local Vaccine Production
A pharmacy in Kenya: Inconsistent regulation across Africa impedes access to new medicines and formulations.

Strengthening Africa’s medicines regulatory framework is key to achieving the “bold goal” of having 60% of the continent’s vaccines produced locally by 2040, said Margareth Ndomondo-Sigonda, head of health at the African Union’s development agency, AUDA-NEPAD.

But only 7% of African country’s national medicines regulatory agencies (NMRA) have “moderately developed capacity”, and more than 90% of the agencies have “either minimal or no capacity at all”, Ndomondo-Sigonda told the opening of a conference on regulation strengthening hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA on Tuesday.

However, she mentioned a number of hopeful signs: five NMRAs have attained World Health Organization (WHO)  Maturity Level Three, which “essentially is a sign of having a robust regulatory system.

In addition, stronger NMRAs such as in South Africa and Egypt have started to work together. 

Regional regulatory bodies have also been set up in west, east and southern Africa 

But real change will happen once a sizeable number of the continent’s 55 countries have signed and ratified the African Medicines Agency (AMA), which aims to harmonise the regulation of medicines on the continent. So far, while some 37 countries have formally supported the treaty, only 26 countries have actually ratified the treaty. While big swingers like Kenya have recently ratified, other leading countries like South Africa and Nigeria have not yet moved to approve the treaty. 


Catching up after COVID

“We are all aware of the fact that the continent was sidelined in the global rush for vaccines in 2021 and 2022 and currently we have fewer than half of the African population that has been fully vaccinated [against COVID-19],” said Ndomondo-Sigonda.

Stung by its exclusion, AU Heads of State and the Africa Centres for Disease Control and Prevention adopted a New Public Health Order in September 2022, with institutional strengthening and local medicine manufacturing making up two of its five pillars.

The Partnership for African Vaccine Manufacturing (PAVM), also established during the pandemic, is overseeing the local production of vaccines with the assistance of Nepad-AUDA’s African Medicines Regulatory Harmonisation Initiative.

Once the AMA is operational – it is in the process of being set up in Rwanda – it will take on the responsibility of ensuring coordinating regulatory systems strengthening, explained Ndomondo-Sigonda.

She expressed concern that countries such as Nigeria, Tanzania and South Africa have yet to ratify the AMA and depose their instrument of ratification –  formal notification that their governance structures have ratified the treaty.

“What is very, very important is for all the stakeholders to see that they have a responsibility to advocate for the ratification of AMA and I think it’s also very important to note the fact that as strong AMA will be based on strong NMRAs,” she added.

She also challenged the pharmaceutical sector, which “has access to politicians”, to advocate for all African countries to fully ratified the AMA.

Currently, 37 countries have taken some action to recognise the AMA – but only 21 of these have fully ratified it.

Image Credits: Luigi Guarino .

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