Continental Forum for Heads of Medicines Registration and Marketing Authorisation Launched


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The African Union Development Agency-NEPAD’s African Medicines Regulatory Harmonization (AMRH) Programme proudly announces the launch of the First Continental Heads of Medicines Registration and Marketing Authorization Forum and the selection of its leadership team.

The Forum will play a vital role in the facilitating translation and adoption of scientific recommendations made by the Evaluation of Medicinal Products Technical Committee (EMP-TC) for human medicinal products listed at the continental level. The esteemed panel of leadership of the Forum was elected during the momentous Continental Forum for Heads of Registration and Marketing Authorization gathering, held on April 11, 2024, in Nairobi, Kenya.

The newly elected leadership comprises Kariuki Gachoki from Kenya as the Chairperson, Dr. Chantel Noufionso from Benin as Vice Chairperson, and Senegal’s Mbagnick Diof, Nazalia Macuwele from Mozambique, and Bathusi Kgosietsile from Botswana serving as Rapporteurs. A representative from Northern Africa is yet to be elected and will be announced in the coming weeks.

“We are excited to introduce this dynamic leadership team for the Continental Forum for Heads of Registration & Marketing Authorization,” said the head of AMRH Ms Chimwemwe Chamdimba. “Their expertise and dedication are instrumental in advancing Africa’s medicine regulatory systems, ensuring the accessibility and safety of medicinal products for all Africans.”

Accepting his role, Mr. Gachoki expressed his gratitude, stating, “It’s a great honor to chair this prestigious forum. I assure you that our recommendations will prioritize the well-being of African citizens. Furthermore, as leaders, we humbly acknowledge that we do not possess all knowledge. We are fully committed to listening to the invaluable contributions of forum members, ensuring that we serve Africa to the best of our abilities”.

This leadership team will play a pivotal role in facilitating the adoption and translation of continental scientific recommendations on medicinal products evaluated and listed by the Evaluation of Medicinal Products Technical Committee (EMP-TC) into national registration and marketing authorization. The Forum will also have a role in fostering collaboration among National Regulatory Authorities, facilitating information exchange, and advocating for continental recommendations to enhance the efficiency of Africa’s regulatory framework. The forum aims to streamline Medicinal product approval processes, contributing to the efficiency and functioning of the African regulatory system.

The conclusion of the election process saw crucial discussions on implementing the continental pilot procedures facilitating Registration & Marketing Authorization for medicinal products in Africa and harmonized mechanisms for adopting continental scientific output guided by recommendations from the Evaluation of Medicinal Products -Technical Committee.

On November 1st, 2023, the African Union Development Agency-NEPAD (AUDA-NEPAD), through the African Medicines Regulatory Harmonization (AMRH) initiative, launched the commencement of the pilot phase for the continental procedure on the evaluation of medicinal products. Spearheaded by the Evaluation of Medicinal Products-Technical Committee (EMP-TC) with the support of the Good Manufacturing Practices-Technical Committee (GMP-TC), this pilot constitutes a cornerstone in the technical operationalization of the African Medicines Agency (AMA). Its overarching objective is to build upon existing regional harmonization efforts, fortifying regulatory frameworks across the continent and fostering regulatory reliance aligned with globally accepted standards.

A widespread call for expression of interest (EOI) was issued, inviting manufacturers and suppliers to partake in the pilot. The continental procedures entail collaborative evaluation of priority medicinal products and inspections of manufacturing facilities by African Union (AU) Member States. Subsequent to this evaluation and inspection, a unified continental recommendation for registration or marketing authorization is formulated.

Recognizing the pivotal role of collaboration among Heads of Marketing Authorization and Registration from African National Regulatory Authorities (NRAs), a Forum was deemed essential for fostering continental regulatory cohesion. This Forum is envisioned to facilitate information sharing, collaborative endeavors, and the formulation of continental recommendations. Its establishment aims to streamline continental product approval processes, thus driving the efficacy of the African regulatory system.

In line with these objectives, the first meeting of the Heads of Marketing Authorization and Registration was convened from April 10th to 11th, 2024, in Nairobi, Kenya. This gathering served to formally inaugurate the Forum and endorse its terms of reference. Additionally, discussions focused on the leadership structure of the Forum and outlining the roles of African NRAs within the continental pathway for evaluating medicinal products. Participants collaboratively devised mechanisms to facilitate the recognition and implementation of continental scientific recommendations in the national marketing authorization processes undertaken by NRAs.

About the African Medicine Regulatory Harmonisation Programme

 The African Medicines Regulatory Harmonization (AMRH) programme, initiated in 2009, addresses challenges faced by National Medicine Regulatory Authorities (NMRAs) in Africa. These include weak legislative frameworks, slow medicine registration, and limited technical capacity, leading to poor access to essential medicines. AMRH aims to harmonize medicine regulation, improving access to quality, safe, and affordable medicines in Africa, aligning with the broader African Union Pharmaceutical Manufacturing Plan for Africa (PMPA). It works on improving registration processes, reducing times, and enhancing decision quality. Implemented under the Program Delivery and Coordination Directorate, AMRH focuses on aligning guidelines for various medical products and regulatory processes, collaborating with NMRAs, Regional Economic Communities (RECs), and partners. RECs supported by AMRH have enhanced their regulatory capabilities, agreed on harmonized technical requirements, and participated in joint assessments, improving access to medical products in their regions.