The Ghana Food and Drugs Authority (FDA) has spearheaded a joint initiative with National Regulatory Authorities (NRAs) in seven African countries to foster trust, enhance regulatory reliance, and streamline approval processes for medicines, vaccines, and medical devices.
This initiative, established through a Memorandum of Understanding (MoU), aims to significantly reduce approval timelines and improve access to essential medical products through internationally recognized best practices.
The seven participating NRAs are from Ghana, South Africa, Nigeria, Rwanda, Tanzania, Zimbabwe, and Senegal.
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 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.
Strengthening Regulatory Collaboration
The landmark MoU was signed in Cairo on February 4, 2025, 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).
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 Harmonization (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.
H.E. 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.
Enhancing Work Efficiency and Collaboration
The Chief Executive Officer of the Ghana FDA, Dr Delese Mimi Darko, described the MoU as a significant milestone for Africa, explaining that it will deepen confidence in the continent’s regulatory systems.
She noted that the agreement commits signatory countries to streamline application submission and evaluation processes, thereby expediting regulatory procedures, reducing costs, and ensuring timely decision-making.
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.
Key Benefits of the Agreement
The MoU establishes mechanisms to ensure that authorized medical products and clinical trials meet internationally accepted regulatory standards.
Dr. Darko outlined the key benefits of the agreement:
(i) Increased Regulatory Efficiency: The MoU enables the sharing of assessment reports, quality control laboratory results, and Good Manufacturing/Clinical Practice (GMP/GCP) inspection reports optimizing efficiency.
(ii) Faster Access to Medical Products: By leveraging shared regulatory decisions, the agreement accelerates the availability of essential medicines and vaccines across Africa.
(iii) Optimised Use of Resources: By minimizing repetitive regulatory work, scarce resources can be reallocated to critical areas such as quality and safety monitoring of medical products.
(iv) Stronger Collaboration: The MoU fosters a cooperative environment where regulatory authorities can benefit from each other’s scientific expertise while maintaining their independent regulatory responsibilities.
This agreement marks a transformative step for Africa’s regulatory landscape, positioning the continent to better respond to health challenges while ensuring timely access to life-saving medical products.
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