The African Union (AU) has made progress towards establishing a continent-wide medical product regulator after reaching the required number of ratifications by member countries.

The Treaty for the Establishment of the African Medicines Agency (AMA) came into effect on 5 November 2021. At a conference in June 2022, the AU reiterated its intention to ensure the operationalisation of the AMA at the earliest stage possible. The hope is that a single regulator across the continent will provide a consistent approach toward developing a reliable and efficient regulatory framework for medical products. The current lack of framework and regulation has proven unattractive to medical manufacturers, which has resulted in low-quality and insufficient medical supplies. This has ultimately had a disastrous impact on many African nations, with low-income regions suffering the most.

With a drive towards a trusted regulatory landscape, there is expected to be an increase in medical manufacturers operating throughout Africa. By 2040 the aim is to manufacture 60% of vaccines consumed in Africa within the continent. In conjunction, clinical trials conducted in African nations are expected to increase and regulation in this area will likely be on the agenda in the coming years.

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