Historic First: AMRH Approves Continental Listing of Human Medicinal Products

In a groundbreaking achievement for Africa's public health sector, the African Medicines Regulatory Harmonisation (AMRH) Initiative has successfully assessed and listed five human medicinal products under the Continental Procedure for Evaluation and Listing of Human Medicinal Products. This milestone marks a major step forward in ensuring African patients have faster access to safe, high-quality, and effective medicines.

The five products approved in the first continental listing include Gardasil 9 (HPV vaccine), among other essential medicines. This achievement was accomplished through collaborative scientific assessment of Quality, Safety and Efficacy by the Evaluation of Medicinal Products Technical Committee (EMP-TC) in collaboration with the Good Manufacturing Practices Technical Committee (GMP-TC).

Key Achievements:

• First-ever continental joint evaluations of medicinal products in Africa
• Five human medicinal products approved under the Continental Procedure
• Introduction of the "Green Book" registry of Continentally Listed Products
• Streamlined regulatory approvals across African Union Member States
• Support for the operationalization of the African Medicines Agency (AMA)

The Continental Procedure directly addresses issues of fragmented regulatory systems, lengthy approval processes, and limited capacity for rigorous product assessments. By streamlining regulatory approvals and fostering reliance among AU Member States, this initiative demonstrates Africa's ability to conduct high-quality collaborative scientific reviews.

Ms Chimwemwe Chamdimba, Head of the AMRH programme, stated: "Beyond strengthening health systems for Africa, this achievement signals a turning point for Africa's pharmaceutical industry, creating an environment that fosters innovation, attracts investment, and accelerates regional trade in medicines. A harmonized regulatory approach streamlines processes for pharmaceutical manufacturers, enabling them to scale production and expand market access across the continent."

The Continental pilot was launched in November 2023, with technical support from the European Medicines Agency (EMA), World Health Organization (WHO), and other partners. Martin Harvey, representing the EMA Head of International Affairs, commended this milestone: "It's truly thrilling to see these first outcomes of the continental joint assessment and GMP inspections. Today is a historic milestone, and I look forward to a long and successful relationship between our two sister agencies, AMA and EMA."

The Green Book:

The Evaluation of Medicinal Products Technical Committee has introduced a registry of Continentally Listed Products, known as the "Green Book", which provides publicly accessible information on approved medicines, regulatory procedures, and scientific aspects of the Continental Listing Mechanism. The Green Book can be accessed on the AMRH website, ensuring transparency and ease of access for regulatory authorities, healthcare providers, and pharmaceutical stakeholders.

The AMRH, under AUDA-NEPAD, will continue supporting AU Member States in integrating these continental recommendations into national regulatory pathways, strengthening Africa's capacity to evaluate, approve, and list essential medicinal products efficiently.