Writing in the July 2025 edition of DIA’s Global Forum magazine, Alex Juma Ismail of the African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) and Vicki Gold, a consultant to the Gates Foundation, unveil the “Continental List of Human Medicinal Products” pilot—a first-of-its-kind initiative led by the African Medicines Regulatory Harmonisation under the AU. The program fast-tracks access to safe, effective treatments by harmonising drug evaluation and approvals across Africa. Through a transparent “Green Book” registry and streamlined review of initial approved products, this pilot paves the way for a unified African Medicines Agency, promising faster, equitable access to medicines continent-wide

 

Imagine being able to access life-saving medicinal products faster, no matter where you live on the African continent. This is the promise behind the Continental List of Human Medicinal Products Pilot, a landmark pilot program led by the African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) through the African Medicines Regulatory Harmonization (AMRH) initiative.

This pilot, launched in November 2023, is the first of its kind in Africa. With technical support from the European Medicines Agency (EMA), the World Health Organization (WHO), and key funding partners including the Gates Foundation, the pilot marks a significant step forward in Africa’s journey to improve access to high-quality, safe, efficacious medicines through regulatory collaboration and reliance.

 

What Is the Pilot About?

At its heart, the Continental List is about trust and transparency. It enables a continent-wide panel of regulatory expert assessors and inspectors from various African national regulatory authorities (NRAs) in countries such as Nigeria, Ghana, Senegal, South Africa, Tanzania, Kenya, and Rwanda, amongst others, to jointly review and issue a “Positive Opinion” on priority human medicinal products, ranging from essential vaccines to advanced cancer therapies.

These products are published in the Continental List of Human Medicinal Products with Positive Opinion – AMRH Green Book, a publicly accessible reference modeled after the US FDA’s Orange Book.

This listing empowers national regulators across Africa to rely on the shared evaluation to accelerate their own approvals, thereby cutting down on duplication, shortening timelines, and reducing barriers to access.

The listings are not marketing authorizations (which refer to the official approval granted by an NRA allowing a medicine to be legally sold and distributed in a specific country) per se but are intended to be used by NRAs as the scientific basis for accelerated decision-making through reliance or recognition mechanisms. This model supports faster and more efficient access to essential medicines while promoting convergence in regulatory standards and capacity development.

 

Major Milestones and Achievements

Since its launch, the initiative has scored several historic achievements, including:

First-Ever Continental Listings (March 2025)

Five life-saving medicinal products were assessed and granted positive opinions by the AMRH Evaluation of Medicinal Products Technical Committee (EMP-TC) and approved for continental listing in the AMRH Green Book by the AMRH Steering Committee:

 

Read the full article on the DIA Global Forum website here