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 brought 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.

Countries in Africa that are currently regulating medical devices have generally been regulating medical devices through agencies originally set up to regulate the pharmaceutical industry.  These agencies continue to function with design, staffing, and orientation to best suit the pharmaceutical industry. Distinguishing between medical devices and pharmaceuticals regulations is crucial due to the inherent differences between these two industries.

This workshop brought together medical device companies, U.S. and African government representatives and multilateral partners to discuss best practices and identify practical steps needed to strengthen regulatory oversight of medical devices and improve market access for these essential health products in the region

On November 13-14, 2023, USTDA held the first of five meetings organized by Corporate Council on Africa (CCA) on regulatory convergence for healthcare products. The first workshop focused on East and Central Africa and was held in Nairobi, Kenya. The two-day program included one day dedicated to pharmaceuticals and the second dedicated to medical devices. The event convened a select group of key stakeholders including decision makers from five African Regulatory Authorities, leadership from the U.S. Food and Drug Administration and more than 100 pharmaceutical and medical device companies.

USTDA Regional Director for Sub-Saharan Africa, Heather Lannigan, opened the conference, noting how important promoting regulatory harmonization is for USTDA’s broader portfolio of promoting health programs in Africa.  She explained this is the first in a series of four regional and one continental workshops on this theme, designed to highlight best practices and promote harmonization between regions, as well as address specific issues related to pharmaceuticals and medical devices. She also thanked the senior officials, Dr. Fred Siyoi, CEO the Pharmacy and Poisons Board Kenya (PPB), Mr. Salvator Sindayigaya, Pharmacist, Director of Human Medicines, The Burundian Regulatory Authority for Medicines for Human Use and Food (ABREMA), Mr. Laurent Patern Tshimpaka K. Regulatory Affairs HOD, Congolese Pharmaceutical Regulatory Authority (ACOREP), and Mr. Jackson Kiberenge, Tanzania Medicines, and Medical Devices Authority (TMDA) for their participation in the inaugural workshop.

The program included discussions on lessons learned from EAC harmonization, private sector recommendations on how to advance regulatory convergence and reliance for medicines as well as medical devices, the importance of distinct regulatory frameworks for medical devices and strategies needed for countries to transition to harmonization. 

 

Click here to view the photos from Day 1 - November 13, 2024

Click here to view the photos from Day 2 - November 13, 2024

For more information, please contact:

Morayor Essieh

messieh@corporatecouncilonafrica.com