Capacity building in medicines development and regulation in Africa-Overview on recent progress

Area of Science:

• Medicines Development and Regulatory Science in Africa

Background:

• African nations face significant resource limitations and fragmented efforts in building capacity for medicines development and regulatory science.
• A shortage of skilled professionals further hinders progress in this critical area.

Purpose of the Study:

• To review existing gaps in medicines development and regulatory science capacity in Africa.
• To assess collaborative approaches for enhancing this capacity.
• To highlight the 10-year contributions of the Fundisa African Academy of Medicines Development.

Main Methods:

• A narrative review was conducted.
• The review focused on capacity-building initiatives in medicines development and regulation across Africa.
• Emphasis was placed on the role of the Fundisa African Academy of Medicines Development and its collaborations with academic institutions, clinical research sites, industry, and regulatory bodies.

Main Results:

• Capacity-building initiatives in Africa are inconsistent and often fragmented.
• Collaborative efforts, exemplified by the Fundisa African Academy of Medicines Development, can address these gaps through accredited training, skills development, and experiential learning.
• These initiatives enhance competencies from drug discovery and clinical research to regulatory affairs and health economic evaluations.

Conclusions:

• Sustainable capacity strengthening requires coordinated, context-specific strategies covering the entire health research value chain.
• Integrating digital health platforms, adopting standardized frameworks (e.g., WHO Global Competency Framework), and centralizing monitoring systems are crucial.
• These measures will reduce fragmentation and foster greater regional collaboration in medicines development and regulatory science.