By Jessica Ahedor
Cairo, Egypt – The 6th Biennial Scientific Conference on Medicines Regulation in Africa (SCoMRA VI), organized by the African Union Development Agency-NEPAD (AUDA-NEPAD) in partnership with the World Health Organization (WHO) and African Medicines Regulatory Harmonization (AMRH) took place in Cairo, Egypt. The conference addressed crucial issues related to healthcare challenges in Africa, with a focus on regulatory advancements and equitable access to life-saving medicines.
Opening Remarks and Strides in Regulatory Systems
David Muganga, Chairperson for AMRH, highlighted SCoMRA’s role in promoting the regulation of medical products, steering Africa towards equitable access to life-saving medicines. Reflecting on the theme, he acknowledged SCoMRA’s instrumental role in strengthening Africa’s harmonization efforts over the years. “Since its inception we can say SCoMRA over the years has been instrumental in strengthening Africa’s harmonization efforts by promoting the regulation of medical products and propelling the continent towards equitable access to lifesaving medicines”.
Addressing Regulatory Challenges
Despite progress, Dr. Muganga stressed the need to address major challenges facing regulatory systems in Africa. He said leadership changes, sustainable financing, human resource constraints, and infrastructure deficiencies are the key challenges so far.
The Regulatory and Prequalification (RPQ) Department emphasized the necessity for a more efficient use of global regulatory resources, citing that 70% of countries have weak national regulatory systems.
Battling Substandard and Falsified Medical Products (SFMP):
In a report presented by the Eritrea pharmacovigilance center, the persistent challenges of substandard and falsified medical products in Africa is having dire consequences of the efforts made so far. Mulugeta Russom of the Eritrean Pharmacovigilance Centre highlighted the global threat of SFMP and the need for understanding, knowledge, and political will in combating falsified medical products.
“FS is declared a global threat because weak regulation and harmonization is a fertile ground for falsification hence in combating falsified medical products, understanding, knowledge and the political will is needed.
In 2014 – 2023, Eritrea alone received ~2,400 suspected SF MPs and was able to recall 100+ SF products”.
International Collaboration against SFMP
Experts stressed the importance of international collaboration in the fight against SFMP. AUDA-NEPAD’s Chimwemwe Chamdimba emphasized unity in action, “Unity in action is our strongest asset,” remarked the AUDA-NEPAD’s Chimwemwe Chamdimba.
Tamer Essam, Chairman of the Egyptian Drug Authority, highlighted the significance of improving the local legal frameworks and strengthening intersectional collaboration on the continent to maximize resources for the fight. “Improving the legal framework and strengthening intersectional collaboration are essential steps to combat SFMP effectively. We need a unified front in this battle, he added
WHO’s Role and Data Sharing
Andrea Keyter from WHO emphasized the crucial role of data and information sharing in the fight against SFMP. Collaboration was highlighted as a strong weapon against this menace, emphasizing the need for a unified front.
“Enhancing data and information sharing on SF medical products among member states is crucial. Collaboration is our strongest weapon against this menace.” – Andrea Keyter said on behalf of Hiti Baran Sillon, unit head, WHO Technical Officer.
The Impact of SCoMRA on Africa’s Healthcare Landscape
The conference, serving as a platform for scientific advances, discussed best practices in regulatory science and encouraged investments in local production of medical products for socio-economic development. SCoMRA, since its inception in 2013, has played a pivotal role in shaping Africa’s healthcare landscape, fostering alliances, fueling research, and facilitating harmonization towards self-sufficiency in medical production.
Continued Progress and the Role of AMA
The impact of regulatory strengthening on the operationalization of the Africa Medicines Agency (AMA) was discussed, highlighting AMA’s functions and its role in sustained continental-wide harmonization.
The journey toward harmonization in Africa, starting from the AU Decision on the Pharmaceutical Manufacturing Plan for Africa in 2005 to the coming into force of the AMA Treaty in 2021, demonstrates the continent’s commitment to regulatory excellence.
The conference highlights the significant role of the African Medicines Regulatory Harmonization (AMRH) initiative, implemented in various regional economic communities. Leveraging structures like the African Vaccines Regulatory Forum (AVAREF) and the African Medicines Quality Forum (AMQF), AMRH has contributed to improved regulatory decisions, reduced registration timelines, and enhanced regulatory capacity.
As Africa progresses in regulatory strengthening, the report emphasizes the importance of collaboration, risk-based approaches, and reliance on trusted regulatory authorities. The AMA is positioned not to replace but to coordinate and complement the work of national regulatory authorities and regional economic communities.
