By:
Nana Appiah Acquaye
The
African Medicines Agency (AMA) and the United States Food and Drug
Administration (US FDA) have signed a Statement of Cooperation aimed at
strengthening regulatory collaboration, information exchange and harmonisation
of medical product oversight between Africa and the United States.
The
agreement, signed in June 2026, establishes a formal framework for cooperation
between the two regulatory institutions, focusing on improving the safety,
quality and efficacy of medical products through science-based regulatory
approaches.
The
Statement of Cooperation was signed by H.E. Dr. Delese Mimi Darko,
Director-General of the African Medicines Agency, and Mark Abdoo, Associate
Commissioner for Global Policy and Strategy at the US FDA.
Under
the agreement, the two agencies will work to facilitate structured exchange of
regulatory information, strengthen existing collaboration mechanisms and
support participation in international regulatory initiatives.
The
framework also provides for coordination of stakeholder engagement activities
relevant to medical product regulation, in line with the mandates of both
institutions.
Both
agencies indicated that the cooperation will contribute to advancing regulatory
convergence across jurisdictions, supporting more efficient oversight of
medicines and health products globally.
The
agreement builds on the establishment of the FDA African Medicines Agency
Liaison Office (AMALO) at the US Embassy in Kigali, which is intended to
enhance ongoing engagement between the US FDA, the AMA and national regulatory
authorities across Africa.
The
AMA noted that the partnership comes at a time when Africa’s pharmaceutical
market is projected to exceed 50 billion dollars by 2030, underscoring the need
for strong and coordinated regulatory systems to ensure timely access to
quality-assured medical products for the continent’s population.
Officials
said the cooperation reflects a shared commitment to strengthening regulatory
capacity across Africa while improving public health outcomes through enhanced
global collaboration.
