Five human medicinal products have been successfully assessed and listed as human medicine.

In a meeting held at Addis Ababa Ethiopia, the listing of the medicines under the continental procedure for evaluation and listing of human medicinal products has been described as a groundbreaking achievement as far as Africa’s public health sector is concerned.

The achievement 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) is a major step forward in ensuring African patients have faster access to safe, high-quality and effective medicines.

The continental procedure used in this pilot directly addresses issues of fragmented regulatory systems, lengthy approval processes, and limited capacity for rigorous product assessments, by streamlining regulatory approvals, fostering reliance among African Union (AU) member states, and supporting the operationalisation of the African Medicines Agency (AMA). These first-ever joint evaluations under this process demonstrate Africa’s ability to conduct high-quality collaborative scientific reviews and facilitate harmonised medicine registration across AU member States.

The continental pilot was launched in November 2023, with the technical support of the European Medicines Agency (EMA), World Health Organization (WHO) and other partners. The European Medicines Agency has further contributed by providing technical expertise, leveraging its experience in coordinating regulatory systems through a well-established technical committee model. This collaborative effort has played a key role in reaching this important breakthrough.

Commenting on this achievement, head of the AMRH programme, Ms Chimwemwe Chamdimba, observed that, besides strengthening health systems for Africa, this listing marks a new turning point for Africa’s pharmaceutical industry and creates an environment that nurtures innovation, attracts investment, and accelerates regional trade in medicines.

A coordinated regulatory approach streamlines processes for pharmaceutical manufacturers, enabling them to scale production and expand market access across the continent and this has been considered to be a crucial step in positioning Africa as a leader in pharmaceutical manufacturing, fully aligned with the African Union’s industrialization and trade goals under the AfCFTA.”

European medicines agency (EMA) head of international affairs, Martin Harvey, hailed this breakthrough saying it was amazing to witness these first outcomes of the continental joint assessment and GMP inspections. He stated that EMA had joined ranks with AUDA-NEPAD in this journey, sharing their own experience of successfully bringing together experts from different countries. The success of AMA will depend on strong regional and national systems. Today is a historic milestone, as we look forward to a long and successful relationship between our two sister-agencies, AMA and EMA.”

“As part of this initiative, the evaluation of medicinal products technical committee has introduced a registry of continentally listed products, known as the Green Book, which will provide 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.”

The African Medicines Regulatory Harmonisation (AMRH) initiative is a continental programme under the African Union development agency-NEPAD, established to strengthen regulatory systems for medicinal products across Africa. It works to improve access to safe, effective and quality-assured medicines by supporting the alignment of national and regional regulatory frameworks, capacity building, and the establishment of robust oversight mechanisms.

AMRH facilitates collaboration among national regulatory authorities, regional economic communities, and stakeholders, reducing duplication of efforts and expediting the approval of essential medical products.

• A Tel Media report / By Wakhungu Andanje