---

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 achieved 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) marks 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 AU Member States, and supporting the operationalization 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 harmonized medicine registration across AU Member States.

---

READ ALSO: FDA approves GSK’s novel first-in-class antibiotic for UTI treatment

---

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 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 milestone.

Speaking on this achievement, 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. This is a critical step in positioning Africa as a leader in pharmaceutical manufacturing, fully aligned with the African Union’s industrialization and trade goals under the AfCFTA."

Representing the European Medicines Agency (EMA) Head of International Affairs, Martin Harvey, commended this milestone:
"….It’s truly thrilling to see these first outcomes of the continental joint assessment and GMP inspections. EMA has accompanied our AUDA-NEPAD colleagues along this journey, sharing our 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, and I 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.

---

Source: AUDA-NEPAD

---