By Moise M. Bahati

Wednesday, August 23, 2023

As Africa strives to combat diseases through advancements in medicine manufacturing, regulatory harmonization has emerged as a pivotal strategy for enhancing efficiency.

This imperative came to the forefront at the commencement of the 9th African Medicines Regulators Conference (AMRC) on Wednesday, August 23, in Kigali. The conference serves as a platform for participants to exchange insights and best practices in regulatory affairs, guiding African Union (AU) entities in vaccine production and medicinal regulations.

Delegates engaged in discussions centered on initiatives and strategies aimed at fortifying African regulatory systems, promoting continental collaboration, bolstering local manufacturing, and eliminating barriers impeding the seamless cross-border movement of high-quality pharmaceuticals.

“Given the variance in regulatory practices across African nations, the accessibility of medical products for African populations has been compromised. The absence of standardized practices has led to the use of substandard and falsified drugs in some regions,” Emile Bienvenu, Director General of the Rwanda Food and Drugs Authority said.

He emphasized, “The harmonization of regulatory practices across African countries is pivotal, and considerable progress has been made in this direction.”

Bienvenu further highlighted that beyond enhancing the quality of medical products, synchronized African regulatory frameworks will contribute to the availability of affordable drugs throughout the continent.

Representatives from approximately 40 national regulatory authorities across the continent are participating in this two-day conference.

The conference was orchestrated by the African Union’s Africa Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), in collaboration with the Africa Medicines Regulatory Harmonization (AMRH) program and the World Health Organization (WHO) Africa Region.

Also on the agenda is the establishment of the African Medicines Agency (AMA), headquartered in Kigali.

The AMA, an AU specialized agency, aims to facilitate the harmonization of medical product regulations across the continent, thereby improving access to safe, effective, and high-quality medical products.

“This conference is opportune, especially considering that many countries in the African Region are actively enhancing their capacity for local medical product production, including vaccines,” Bienvenu said.

He underlined that Rwanda is at the forefront of prioritizing local pharmaceutical production, evident through its partnership with BioNTech to manufacture crucially needed vaccines on the continent.

Once fully operational, the AMA will oversee the harmonization of medical product regulations, encompassing medicines and vaccines, throughout the continent.

Presently, 26 out of the AU’s 54 member states have ratified the AMA treaty.

Symerre Grey-Johnson, Director of Human Capital and Institutional Development at AUDA-NEPAD, stressed the need for increased advocacy to encourage more countries to adopt the AMA.

“We must intensify our advocacy efforts, making the agency more compelling and comprehensible, thus encouraging additional ratifications. The momentum is strong, steady, and promising; we anticipate continued ratifications over the next few months,” Greg-Johnson said.

For the original press release, please click here.