The U.S. Trade and Development Agency (USTDA) in collaboration with the Corporate Council on Africa (CCA) presents a Workshop Series on Regulatory Convergence for Healthcare Products in Africa.

In this series, we will host four distinct, regionally focused workshops that will set the stage and lead up to a final continent-wide workshop. Each workshop will include a dedicated day for pharmaceutical products and another dedicated day for medical devices. These sessions will convene a select group of key stakeholders, including pharmaceutical and medical device companies, trade associations from both the United States and Africa, as well as regulatory authorities and government agencies from both regions. The primary objective is to foster discussions on the most effective regulatory practices for pharmaceuticals and medical devices, with the overarching goal of promoting harmonization with international standards and achieving convergence in healthcare regulatory systems.

Through this series, we aim to:

• Promote increased collaboration between regulatory authorities and industry.
• Facilitate broader market access for healthcare products while enhancing the quality and availability of pharmaceuticals and medical devices across the continent.
• Improve application and approval timelines/processes.
• Provide a platform for participants to network and exchange ideas, experiences, and best practices for strengthening regulatory systems in Africa.

The U.S. Trade and Development Agency (USTDA) will host the second event in its workshop series on Regulatory Convergence for Healthcare Products in Africa on March 12 & 13, 2024 at the Radisson Blue Gautrain Hotel in Johannesburg, South Africa. This workshop series is organized by the Corporate Council on Africa and includes five regionally focused workshops that convene pharmaceutical and medical device companies, U.S. and African government representatives and multilateral partners to discuss best practices and identify practical steps needed to strengthen regulatory systems and improve market access for essential medical products in Africa.

This workshop will spotlight the developments and successes of the ZAZIBONA program, which recently celebrated 10 years of operation. Panel discussions will also focus on what’s next for regulatory harmonization in the SADC region. For medical devices, attention will be given to navigating medical devices regulatory pathways from the perspectives of innovators, local manufacturers, importers and other stakeholders in the value chain. Outcomes of the workshop will be action-oriented and contribute towards the culmination of a continental view of regulatory harmonization for pharmaceuticals and medical devices.

• Explore lessons learned from the implementation of the ZAZIBONA program.
• Learn how technology can improve communication, regulatory process efficiency, transparency and governance.
• Participate in B2B and B2G discussions about what is needed to transition to harmonization
• Discover sustainable financing models for regulatory harmonization.
• Understand the differences between medical devices vs pharma across the value chain.
• See live demonstrations of new medical devices available in the market.