Regulatory Convergence for Healthcare products in Southern Africa

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 frameworksgoverning medical devices and diagnostics. Despite notable progress, there'srecognition of the need for further exploration and refinement in this complexdomain. A central focus of discussion was on the differentiation of medicaldevices and diagnostics in terms of regulatory framework development and implementation. Thesedistinctions have significant implicationson innovators and companies seeking regulatoryapprovals for the same devices in different jurisdictions; differentclassifications can have major impacts on device availability and use.Panelists also discussed the need for regulatory impact assessments to betterunderstand 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 intotheir expertise, effective implementation strategies can be developed,fostering an environment conducive to medical device innovation andaccessibility.

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 event.

‍