U.S. Trade and Development Agency and the Corporate Council on Africa Present: Workshop on Regulatory Convergence for Healthcare Products in West Africa

The West Africa Health Regulatory Workshop, organized by the U.S. Trade and Development Agency (USTDA) and the Corporate Council on Africa (CCA), took place on July 16-17, 2024, at the Transcorp Hilton in Abuja, Nigeria. The workshop focused on regulatory convergence in the health sector, specifically pharmaceuticals and medical devices, with key stakeholders from the public and private sectors engaging in discussions on improving regulatory harmonization across West Africa.

Day one concentrated on pharmaceutical regulatory pathways. The event began with opening remarks by Josh Egba (USTDA), David Greene (U.S. Embassy in Nigeria), and Dr. Abdu Mukhtar (National Coordinator of Nigeria’s Presidential Initiative for Unlocking the Healthcare Value Chain). Regulatory leaders including Prof. Moji Adeyeye, Director General, National Agency for Food and Drug Administration and Control, Nigeria (NAFDAC) and Dr. Assane Coulibaly Director General, Ivorian Pharmaceutical Regulatory Agency (AIRP), discussed the progress made in reliance models and the importance of regulatory harmonization to strengthen Africa’s healthcare systems. The session also focused on the role of regional centers of excellence in capacity building. Industry leaders from Pfizer, MSD, and Roche Diagnostics explored how digital technologies are transforming regulatory processes, enhancing transparency, and fostering governance across the pharmaceutical sector. Experts analyzed advancements in regulatory harmonization and shared insights on best practices in stakeholder engagement, benchmarking, and consultation processes.

Day two shifted focus to the regulatory landscape for medical devices, emphasizing the unique challenges and opportunities in harmonizing standards across the region. Regulatory leaders, including H.E. Dr. Zainab Bagudu, CEO, Medicaid Diagnostics and Medicaid Cancer Foundation, discussed the differences between medicines and medical devices, emphasizing the need for differentiated regulatory standards for medical devices and in vitro diagnostics (IVDs). Sessions explored the practical implementation of reliance models for medical devices. Key challenges such as submission of samples, localized labeling, and Good Manufacturing Practice (GMP) inspections were discussed by representatives from Abbott, Medtronic, and Johnson & Johnson. Dr. Abdu Mukhtar, the National Coordinator of the Presidential Initiative for Unlocking the Healthcare Value Chain, Nigeria provided a special presentation on the Presidential Initiative for Unlocking the Healthcare Value Chain, Nigeria. Arun Venkataraman, Assistant Secretary of Commerce for Global Markets and Director General of the U.S. and Foreign Commercial Service also provided special remarks highlighting the importance of public private collaboration to achieve stronger regulatory harmonization in the region. The final session discussed the feasibility of launching a pilot initiative for harmonized medical device regulatory reviews in West Africa, providing a forward-looking framework for regulatory alignment.

The workshop also including networking opportunities aimed at fostering collaboration between regulators, industry leaders, and other stakeholders, ensuring that Africa’s regulatory environment is ready to meet the needs of the rapidly evolving health products landscape.