Africa Moves to Harmonize Medical Product Regulations for Stronger Health Systems
AMA's director-general (DG) Dr Delese Darko. (Photo/ Courtesy)
By Mbungu Harrison
Email, thecoastnewspaper@gmail.com
The African Medicines Agency (AMA) has announced a continent-wide initiative to harmonize medical product regulations, a landmark step aimed at eliminating substandard products and ensuring access to safe, high-quality medicines and vaccines across Africa.
Speaking at the 7th Biennial Scientific Conference on Medical Products Regulation in Africa (SCoMRA VII) held in Mombasa, AMA’s director-general (DG) Dr Delese Darko described the harmonization effort as “long overdue” emphasizing that it would strengthen national regulatory systems rather than replace them.
“Our goal is not duplication but collaboration. By aligning regulations, we can ensure that every medical product used in Africa meets the same high standards of quality, safety, and efficacy,” said Dr. Darko.
The DG explained that the initiative focuses on standardizing regulatory frameworks to improve product quality and safety.
It will also prioritize collaboration with national regulators to create an efficient and transparent system while complementing, rather than overshadowing, the work of national authorities.
The overarching goal is to ensure that every medical product used in Africa meets the same high standards of quality, safety, and efficacy.
The initiative forms part of Africa’s broader vision for health independence, reducing reliance on imported medicines while fostering local innovation and production.
She said that by harmonizing regulations and building local capacity, the continent is unlocking its potential to produce its own life-saving medicines and vaccines.
The initiative forms part of Africa’s broader vision for health independence, reducing reliance on imported medicines while fostering local innovation and production.
AUDA-NEPAD chief executive officer (CEO) Dr Nardos Bekele-Thomas lauded the effort, calling SCoMRA “a collective commitment to Africa’s health sovereignty.”
“By harmonizing regulation and building local capacity, we are unlocking the continent’s potential to produce its own life-saving medicines and vaccines,” she said.
Representing President William Ruto at the conference, Kenya’s Health Cabinet Secretary Aden Duale reaffirmed Kenya’s dedication to ending counterfeit medical products and strengthening domestic production.
“Africa still imports more than 90 percent of its medicines. Strengthening regulatory systems and investing in local manufacturing are essential if we are to achieve true health sovereignty,” he noted.
According to him Kenya is rolling out end-to-end digital systems for procurement, quality surveillance, and product traceability to eliminate falsified commodities.
“By ensuring every shipment is verifiable from production to patient, we protect citizens, inspire investor confidence, and guarantee value for public resources.”
The harmonization agenda championed at SCoMRA VII marks a decisive step toward a unified regulatory framework that could transform Africa’s healthcare landscape ushering in a new era of safety, innovation, and self-reliance in medical product regulation.
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