FDA Delegation Begins Trip to Africa

An FDA delegation, led by Associate Commissioner for Global Policy and Strategy Mark Abdoo, has begun a two-city trip to Africa for meetings with regulators, multilateral organizations, industry, academia, and civil society.

The trip began on June 20 in Nairobi, Kenya, when the delegation met with Kenya’s Ministry of Health (MOH) to discuss how the FDA might support the Ministry’s goals with the MOH’s Acting Director General Dr. Patrick Amoth.

Following that meeting, the delegation visited the Nairobi offices of the FDA’s regulatory counterpart, the Pharmacy and Poisons Board, which is part of Kenya’s Ministry of Health.

After wrapping up a discussion with Dr. Ahmed Mohamed, PPB’s Director of Health Products and Technologies, Associate Commissioner Abdoo signed a Statement of Cooperation (SOC) with the PPB to strengthen existing structures and develop new opportunities for cooperative engagement in regulatory and scientific matters and public health protection.

The FDA has been providing technical support to the PPB, which currently serves as vice chair of the African Medical Devices Forum. The Forum is working to establish a harmonized framework for regulation of medical devices – including in vitro diagnostics – in Africa. The FDA’s interactions with PPB culminated in the FDA signing a confidentiality commitment on medical devices with the PPB on March 15 in Washington, D.C. The CC set up a legal framework for the signatories to share certain kinds of nonpublic information with each other, as a first step toward a close collaboration between the agencies. The SOC is a follow-on to the CC.

During its trip to Kenya, the FDA delegation also paid a visit to the World Health Organization’s regional office in Nairobi where they met with the WHO’s representative to Kenya, Dr. Abdourahmane Diallo, and his team to provide an update on the FDA’s regulatory work in Africa and identify opportunities for regional coordination and collaboration with the WHO.

On June 21, the delegation participated in a roundtable discussion with pharma leaders in Kenya to understand challenges and opportunities for improving the state of pharmaceutical manufacturing in Kenya. The country currently imports 70 percent of required biologics and medications but is emerging as pharmaceutical hub in East Africa, with a focus on producing generic medicines.

The FDA delegation will travel to Kigali, Rwanda, next.