CEO of Ghana’s Food and Drugs Authority (FDA) Dr Delese Mimi Darko has been appointed the inaugural Director-General of the African Medicines Agency (AMA) by the agency’s Conference of State Parties (CoSP) at a meeting in Rwanda this week.

Darko has a “wealth of experience and a distinguished track record in regulatory excellence”, according to a media release from the African Union.

Darko has been CEO of Ghana’s FDA since 2017, currently chairs the WHO African Vaccines Regulatory Forum and serves on several international and local committees related to medicines and regulation.

“The appointment of the Director General is an important step toward the operationalisation of AMA,” said Ambassador Amma Twum-Amoah, the AU’s Commissioner for Health, Humanitarian Affairs and Social Development. 

“The AMA has been established to harmonise and strengthen regulatory systems for medical products across Africa. We are confident that under Dr Darko’s leadership, the agency is poised to accelerate its efforts in coordinating and standardising regulatory practices, facilitating joint assessments and inspections, and fostering a harmonised approach to medicines regulation that will ultimately benefit all African citizens,” added Twum-Amoah.

Dr Francine Dekandji, Chad’s Minister of State of Health and chairperson of the CoSP, said that AMA “is crucial for ensuring that medical products on our continent meet international standards of quality, safety, and efficacy”. 

The CoSP also elected a new Bureau to guide its future work and endorsed an additional member to the AMA Governing Board. 

Establishing the agency has been a slow process in the evolution of the harmonisation of the regulation of medicines on the continent.

“The appointment of Dr Darko as the Director General of the AMA represents an important milestone for the organization. The depth of her scientific and regulatory experience will be invaluable in shaping the future of medicine regulation in Africa,” said David Reddy, Director General of the International Federation of Pharmaceutical Producers and Manufacturers Associations (IFPMA).

“By supporting national regulatory authorities across the continent, the AMA has real potential to help facilitate faster access to quality medicines, contribute to tackling substandard and falsified medicines, and support medical innovation.”

Bunmi Femi-Oyekan and Zainab Aziz, co-chairs of the Africa Regulatory Network at IFPMA, both offered their congratulations.

“Under her leadership, the AMA can make important progress in its mission to strengthen initiatives to harmonise medicines regulation and promote cooperation and reliance of regulatory decisions,” said Femi-Oyekan.

Aziz described her appointment as “a crucial step toward a fully functional agency that has the potential to transform access to quality-assured medicines across Africa and foster a more predictable, efficient regulatory environment for innovation”. 

Image Credits: African Union.