Unlocking Africa’s Health Potential: Harmonized Regulation as a Catalyst for Local Manufacturing

Africa is undergoing an unprecedented transformation in its regulatory and pharmaceutical landscape. With the operationalization of the African Medicines Agency (AMA), the expansion of AMRH harmonization initiatives, and the growing number of countries targeting WHO Global Benchmarking Maturity Level 3, the continent is building the foundations for a robust, predictable, and collaborative regulatory ecosystem. At the same time, governments and regional blocs are accelerating local manufacturing and technology transfer policies to reduce dependency on imports, improve supply chain resilience, and ensure equitable access to essential health products.

The session will explore these converging trends—regulatory harmonization and localization—and how they are reshaping Africa’s pharmaceutical future. It will highlight success stories from across the continent, including reliance models, fast-track procedures, and regional manufacturing hubs emerging in East, West, and North Africa.

The session will also present how ACCESS Health International is contributing to this transformation through technical assistance, regulatory capacity building, market access strategy, and facilitation of cross-border technology transfer partnerships between Africa, India, and the Middle East. Participants will gain a clear understanding of what is changing, why it matters now, and how innovation-driven regulation can unlock Africa’s potential in health sovereignty and sustainable access to medicines.

Learning Objectives:

A. Understand Africa’s evolving regulatory environment

B. Identify key opportunities for industry and governments

C. Learn from successful Indian case studies

D. Understand ACCESS Health’s role and partnership model