ARTICLE SUMMARY:
The launch of the African Medicines Agency and building a sustainable health technology infrastructure. Market Pathways spoke to Paulyne Wairimu, a top device regulator in Africa, about efforts toward harmonization on the continent.
The African Union’s 55 member states and 1.5 billion people represent a region of vast diversity and complexity. Stark disparities in economic development, healthcare infrastructure, and regulatory capacity—compounded by linguistic heterogeneity—pose formidable challenges to the harmonization of medical device regulation. Nonetheless, meaningful progress has been made, and the continent now stands on the brink of a major milestone: the launch of the African Medicines Agency (AMA). 
AMA will centralize regulatory activities, including premarket reviews for drugs, vaccines, and medical devices deemed priorities for the region. It will also be tasked with strengthening and harmonizing national regulatory frameworks throughout Africa, leveraging global best practices as established by the World Health Organization, the International Medical Device Regulators Forum (IMDRF), and other groups.
Efforts have been building toward AMA for the past two decades, but more recent experiences during the COVID-19 pandemic put a spotlight on Africa’s fragmented health systems and helped expedite the project, suggests Paulyne Wairimu, Kenya’s top device regulator and chair of the African Medical Devices Forum.
“The challenges are many and unique,” Wairimu said in an interview. “But COVID-19 demonstrated that we have to be able to look within to develop sustainable mechanisms that can help us to face the ever-threatening infectious diseases.”
