This initiative, established through a Memorandum of Understanding (MoU), signed between Ghana and six other Africa countries aimed to significantly reduce approval timelines and improve access to essential medical products through interna­tionally recognized best practices.

The other participating NRAs are from South Africa, Nigeria, Rwanda, Tanzania, Zimbabwe, and Senegal.

The landmark MoU was signed in Cairo on February 4, under the auspices of the African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) and the Africa Centres for Disease Control and Prevention (Africa CDC).

Currently, the medicine approval process can take six months and beyond before a product is granted market access.

However, with this MoU, this process could be reduced significantly to as little as three months.

The Chief Executive Officer of the Ghana FDA, Dr Delese Mimi Darko, in a statement issued after the signing the MoU described it as a significant milestone for Africa, explaining that it would deepen confidence in the continent’s regulatory systems.

She noted that the agreement commits signatory countries to streamlining applica­tion submission and evaluation processes, thereby expediting regulatory procedures, reducing costs, and ensuring timely deci­sion-making.

Dr Darko outlined the key benefits of the agreement which includes increased regulatory efficiency.

“The MoU enables the sharing of assessment reports, quality control labo­ratory results, and Good Manufacturing/Clinical Practice (GMP/GCP) inspection reports optimising efficiency, faster access to medical products.

Through the MoU, participating NRAs will share information, collaborate on regulatory assessments, and partially or fully rely on one another’s reports to avoid duplication of efforts.

The African continent has also made remarkable progress in strengthening its regulatory capacity, increasing the number of NRAs with WHO Maturity Level 3 sta­tus from just one in 2019 to eight in 2024.

Before this MoU, African countries typically entered into reliance agreements with strong regulatory agencies in Western countries.

This agreement, however, marks a sig­nificant shift by establishing a framework for African NRAs who have attained ML3 status meaning that they have a stable and well-functioning regulatory system and even advanced systems for some regulatory functions to rely on each other’s regulatory decisions, reinforcing intra-African trust and collaboration.

The CEO of AUDA-NEPAD, H.E. Nardos Bekele-Thomas, also emphasized the importance of the agreement and commended Ghana for spearheading the initiative.

“This MoU comes at a critical moment as the African Medicines Regulatory Harmonisation (AMRH) prepares for the transition towards the African Medicines Agency (AMA),” she stated.

For Africa to achieve a harmonised regulatory system, she stressed the need for countries to build trust in each other’s regulatory decisions.

Dr Jean Kaseya, Director General of Africa CDC, highlighted the significance of the MoU in supporting Africa CDC’s efforts to expand local vaccine and health commodity manufacturing.

He noted that it also strengthens Africa CDC’s ability to respond swiftly to public health crises by ensuring that regulatory processes for medicines, vaccines, and diagnostics are more agile, efficient, and collaborative.

Experts view this MoU as a critical step in fostering collaboration and ensuring that safe, effective medical products reach Af­rica’s populations faster. It also reinforces the continent’s commitment to strengthen­ing its capabilities for local manufacturing to meet its health needs.

The MoU establishes mechanisms to en­sure that authorised medical products and clinical trials meet internationally accepted regulatory standards.