By Baboloki Semele: In a landmark achievement, Africa has officially reached full regional regulatory harmonization, bringing the continent one step closer to uniform medicine standards. This historic accomplishment comes with the successful establishment of the North Africa Medicines Regulatory Harmonization (NA-MRH) Initiative, which completed the regional regulatory framework for the entire continent.
The historic milestone was celebrated with the inaugural NA-MRH meeting in Cairo, Egypt, held from February 18-20, 2025. This meeting marked the final piece of the puzzle, solidifying Africa’s vision for a fully harmonized regulatory system for medical products. The achievement underscores the continent’s unwavering commitment to ensuring the availability of safe, effective, and high-quality medicines for all Africans.
With the inclusion of North Africa in the regional harmonization effort, the African Union’s vision for a unified regulatory landscape now encompasses all five geographic regions of the continent. This development signals a transformative shift in Africa’s healthcare sector, with the potential to positively impact millions of lives.
Mrs. Nardos Bekele-Thomas, CEO of the African Union Development Agency-NEPAD, expressed her enthusiasm, stating, “This milestone signals a transformative moment for Africa’s health sector, reinforcing the continent’s commitment to a robust and efficient regulatory landscape. With all five African geographic regions now actively engaged in medicine regulatory harmonization, the African Medicines Agency (AMA) is poised to drive a new era of strengthened medicines regulation, benefiting millions across the continent.”
The Cairo meeting also saw the formation of the Steering Committee Bureau for the NA-MRH Initiative, with Egypt appointed as Chair, Morocco as Vice Chair, and Tunisia serving as the Secretariat. Additionally, the Terms of Reference and Road Map for the initiative were approved, along with the designation of lead and co-lead National Regulatory Authorities (NRAs) responsible for key regulatory functions. This formalized structure marks the beginning of a coordinated and unified regulatory system in North Africa that will align with the broader continental framework overseen by AMA.
The NA-MRH Initiative unites key North African countries—Algeria, Egypt, Libya, Mauritania, Morocco, and Tunisia—in a collective effort to strengthen medicine regulation across the region. Notably, four of these nations are already parties to the AMA Treaty, and their involvement in the initiative is expected to enhance regional cooperation, streamline regulatory processes, and facilitate knowledge exchange among national regulatory authorities.
Looking ahead, the NA-MRH Initiative will focus on strengthening essential regulatory functions such as marketing authorization, good manufacturing practices (GMP), quality management systems (QMS), pharmacovigilance, and information management systems. The newly formed Steering Committee will play a pivotal role in overseeing the implementation of strategies aimed at creating a harmonized and efficient regulatory environment, ensuring that high-quality medical products are accessible to populations across North Africa and the wider African continent.
The completion of regional regulatory harmonization is a game-changer for Africa. It is a significant step toward fostering public health, driving innovation, and promoting greater access to life-saving medicines. The NA-MRH Initiative stands as a testament to Africa’s determination to protect the health of its people and to create an environment in which health systems can thrive.
As the continent moves forward, the success of the NA-MRH Initiative paves the way for a more robust, coordinated, and equitable approach to medicine regulation across Africa, one that will positively affect millions and elevate the global standing of the continent’s health sector.
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.