The U.S. Trade and Development Agency (USTDA) in collaboration with the Corporate Council on Africa (CCA) presented 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) hosted 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 was 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 spotlighted the developments and successes of the ZAZIBONA program, which recently celebrated 10 years of operation. Panel discussions focused 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.

On March 12-13, 2024 the U.S. Trade and Development Agency (USTDA) hosted the second of five meetings organized by Corporate Council on Africa (CCA), on Regulatory Convergence for Healthcare Products in Africa. The workshop focused on Southern Africa and was held in Johannesburg, South Africa. The first day covered pharmaceuticals, and the second day focused on medical devices. The meeting convened key stakeholders including U.S. and African pharmaceutical and medical device companies, as well as decision makers from six African regulatory authorities, the U.S. FDA, the U.S. Department of Health and Human Services (HHS), The U.S. Embassy in South Africa and South Africa’s National Department of Health. 

USTDA Regional Director for Sub-Saharan Africa, Heather Lannigan, opened the workshop and thanked the senior officials, Dr. Boitumelo Semete, CEO, South African Health Products Regulatory Authority (SAHPRA), Dr. Tânia Vuyeya Sitoie, CEO, National Medicines Regulatory Authority of Mozambique (ANARME), Ntsetselele Kago, Human Medicines Manager, Product Evaluation and Registration, Botswana Medicines Regulatory Authority (BoMRA), Keselofetse Samson, Manager Complementary Medicine and Cosmetics; Product Evaluation and Registration, BoMRA, Fransina Nambahu, Registrar of Medicines, Namibian Medicines Regulatory Council (NMRC) and Dr. José Chocolate Lelo Zinga, Senior Pharmacist, Angolan Regulatory Agency for Medicines and Healthcare Technologies (ARMED) for their participation in the workshop. 

On day one of the workshop, speakers noted that significant progress has been made in developing harmonized joint review processes in the SADC region – however, more work needs to be done in terms of national legal reform to avoid unintended consequences of complexity and duplication of processes. Panelists emphasized the pivotal role of the private sector in navigating regional and national regulatory pathways and noted that sustainable finance models for regulatory harmonization should prioritize private sector engagement, particularly in incorporating user fees. Panelists also discussed the benefits of digital transformation, strategies for regulatory capacity building and leadership development and lessons learned from ZAZIBONA. 

On day two, speakers discussed the regulatory frameworks governing medical devices and diagnostics. Despite notable progress, there’s recognition of the need for further exploration and refinement in this complex domain. A central focus of discussion was on the differentiation of medical devices and diagnostics in terms of regulatory framework development and implementation. These distinctions have significant implications on innovators and companies seeking regulatory approvals for the same devices in different jurisdictions; different classifications can have major impacts on device availability and use. Panelists also discussed the need for regulatory impact assessments to better understand the impact of new and existing regulatory standard implementation. Speakers noted that collaboration with experienced agencies is crucial, especially in regions with evolving regulatory landscapes. By tapping into their expertise, effective implementation strategies can be developed, fostering an environment conducive to medical device innovation and accessibility. 

The program included live device demonstrations from Becton Dickinson, Medtronic and the University of Cape Town. The device demos highlighted the practical aspects of medical device innovation and development, offering insights on regulatory hurdles faced by diagnostics, global medical device companies, and local innovators.

The workshop provided valuable insights into advancing regulatory harmonization and efficiency in the SADC region. By fostering ongoing dialogue and collaboration among stakeholders, we can strive towards harmonized regulatory frameworks that promote innovation while ensuring patient safety and accessibility. The next workshop will be held in Abuja, Nigeria on July 16-17, and will focus on West Africa. 

 

Click here to view the photos from the workshop. 

For more information, please contact:

Morayor Essieh

messieh@corporatecouncilonafrica.com