By Baboloki Semele: In a landmark achievement for Africa’s pharmaceutical and public health sectors, the African Medicines Regulatory Harmonisation (AMRH) Initiative has successfully evaluated and listed five human medicinal products under the Continental Procedure for Evaluation and Listing of Human Medicinal Products. This historic breakthrough streamlines access to high-quality, safe, and effective medicines across the continent, reinforcing Africa’s commitment to strengthening its health systems.
The milestone was reached through a collaborative scientific assessment by the Evaluation of Medicinal Products Technical Committee (EMP-TC) in partnership with the Good Manufacturing Practices Technical Committee (GMP-TC). This first-of-its-kind joint evaluation showcases Africa’s growing capability to conduct rigorous, harmonized medicine registration processes across African Union (AU) Member States.
Addressing Regulatory Barriers for Faster Access to Medicines
Historically, Africa has faced challenges in medicine regulation, including fragmented regulatory systems, prolonged approval timelines, and limited capacity for rigorous product evaluations. The Continental Procedure introduced by AMRH directly tackles these challenges by streamlining regulatory approvals and fostering reliance among AU Member States. The initiative also supports the operationalization of the African Medicines Agency (AMA), further solidifying Africa’s role in global pharmaceutical governance.
The pilot program for the Continental Procedure was launched in November 2023, with technical backing from the European Medicines Agency (EMA), World Health Organization (WHO), and other partners. The EMA played a crucial role in sharing expertise and technical know-how, drawing from its extensive experience in coordinating regulatory systems across Europe.
A Game-Changer for Africa’s Pharmaceutical Industry
Ms. Chimwemwe Chamdimba, Head of the AMRH programme,
Commenting on this achievement, Ms. Chimwemwe Chamdimba, Head of the AMRH programme, emphasized the broader economic and industrial impact of the initiative:
“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.”
European Medicines Agency (EMA), Martin Harvey, Head of International Affairs
Representing the European Medicines Agency (EMA), Martin Harvey, Head of International Affairs, praised this significant milestone saying
“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 the “Green Book”, a publicly accessible registry of Continentally Listed Products. This database provides transparent information on approved medicines, regulatory procedures, and scientific details of the Continental Listing Mechanism. The Green Book is available on the AMRH website, ensuring accessibility for regulatory bodies, healthcare providers, and pharmaceutical stakeholders https://amrh.nepad.org/publication/continental-list-of-human-medicinal-products-positive-opinion-green-book.
The press release from African union development Agency, (AUDA-NEPAD) says moving forward, the AMRH, under AUDA-NEPAD, will continue supporting AU Member States in integrating these continental recommendations into national regulatory pathways. This will enhance Africa’s ability to evaluate, approve, and list essential medicinal products efficiently, reducing dependency on external markets and promoting self-sufficiency in healthcare innovation.
The success of this initiative according to AMHR signals a new era for Africa’s pharmaceutical industry, paving the way for greater investment, innovation, and intra-continental trade in the healthcare sector. With strengthened regulatory frameworks and collaborative efforts, Africa is on track to achieve greater medicine security and accessibility for its people.
About AMRH
African Medicines Regulatory Harmonization (AMRH) programme started in 2009 as a response to addressing challenges faced by National Medicine Regulatory Authorities (NMRAs) in Africa. These challenges include; weak or non-coherent legislative frameworks, sluggish medicine registration processes and subsequent delayed approval decision, inefficiency and limited technical capacity, among others. This situation translates in to poor access to priority essential medicines by patients and is a contributing factor to over-priced medicines.
The aim of the programme is to facilitate and coordinate the harmonization of medicines regulation and improve access to quality, safe, efficacious and affordable medicines in Africa as part of the broader African Union Framework on Pharmaceutical Manufacturing Plan for Africa (PMPA). To achieve this aim, AMRH works towards improving medicine registration processes and operational inefficiencies, thereby reducing registration times whilst enhancing the quality of the registration decision. The programme is implemented under the Program Delivery and Coordination Directorate.
