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.

Convergence of regulatory requirements has many benefits, such as ensuring favorable marketing conditions to support early access to medicinal products, promoting competition and efficiency, and reducing unnecessary duplication of clinical testing. Achieving convergence of pharmaceutical regulations in Africa would also assist continental efforts for the control of a growing cross-border market of substandard and falsified medicines in circulation in the continent. This workshop will bring together pharmaceutical companies, U.S. and African government representatives and multilateral partners to discuss best practices and identify practical steps needed to strengthen regulatory oversight of pharmaceuticals and improve market access for these essential medicines in the region.

• Understand lessons learned from East and Central African health regulatory harmonization and implementation.
• Learn how digital technologies can be used to improve communication, regulatory process efficiency, transparency and governance to accelerate access to existing and new medicines. 
• Gain insight on what it will take for countries to transition from the current differentiated policies and guidelines to a more harmonized African health regulatory environment.
• Learn sustainable financing models that support efficient health regulatory systems.