Hosted by the African Union Development Agency (AUDA-NEPAD) and World Health Organization (WHO), the seventh biennial Scientific Conference on Medical Products Regulation in Africa (SCoMRA) takes place November 11 – 13, 2025 in Mombasa, Kenya. This year’s theme, “Regulatory harmonization: Unlocking Africa’s potential in health product manufacturing and trade,” will bring together manufacturers, regulators, policymakers, researchers, and other stakeholders across the continent to highlight next steps in advancing regulatory science and strengthening regulatory systems to support regional manufacturing. USP is a proud gold sponsor of the event.
USP participation
Parallel session: Bioequivalence centres & regulatory requirements
Tuesday, November 11, 4:30 pm - 6:00 pm EAT
Bioequivalence (BE) studies are essential to ensuring the quality, safety, and efficacy of generic medicines. As pharmaceutical manufacturing continues to expand across Africa, so does the demand for BE centres capable of generating reliable data to support regulatory decision-making. However, the continent faces gaps in BE infrastructure, technical capacity, and regulatory requirements. This session brings together regulators, industry experts, and partners to discuss the current landscape of BE centres and regulatory requirements in Africa, ongoing continental initiatives to align BE standards, examples of functioning BE centres and regulators, and opportunities for collaboration.
Speakers:
- Dr. Loice Kikwai, Regulatory Affairs Lead, Market Access Africa
- Luther Gwaza, Team Lead, Norms and Standards for Pharmaceuticals, World Health Organization (WHO)
- M’sanide Sakala, Chairperson, Bioavailability/Bioequivalence (BA/BE) Technical Working Group, African Medicines Regulatory Harmonization (AMRH)
- Dr. Leigh Verbois, Sr. Director, Global Regulatory and Laboratory Programs, USP
- Brayhan Ireri, Pharmacy and Poisons Board Kenya
- Thavandree Gopal, Chief Regulatory Officer, South African Health Products Regulatory Authority (SAHPRA)
- Dr. Mekonnen Teferi, Director, Clinical Trials Directorate, Armauer Hansen Research Institute (AHRI)
Skhumbuzo Ngozwana, Vice Chairperson, Federation of African Pharmaceutical Manufacturers Associations (FAPMA)
Abstract presentation: Access for Africa — Advancing medicine quality through free access to USP standards and education
Wednesday, November 12, 2:00 pm - 3:30 pm EAT
This presentation highlights how strengthening regulatory systems is key to ensuring quality medicines and how strategic collaboration can help address complex health challenges. Specifically, this presentation explores the critical role of public-private partnerships in strengthening regulatory frameworks, with a special focus on USP's Access for Africa (A4A) initiative launched in June 2024. Results from the initiative provide insights into the co-development of regulatory guidance, innovative governance models, and mechanisms that promote transparency, shared ownership, and technological innovation. The initiative also highlights how strategic partnerships can create scalable solutions to complex regulatory challenges, ultimately improving medicine quality and accessibility across Africa.
Speaker: Everlyne Murithi, Strategic Customer Development Manager, USP
Abstract presentation: Early lessons in environmental sustainability and practical, scalable solutions for a greener Africa
Thursday, November 13, 11:30 am - 1:00 pm EAT
This presentation will share practical lessons for environmental sustainability in pharmaceutical manufacturing, advocate for scalable models, and emphasize that with regulatory collaboration, public-private partnerships, and climate financing, Africa can achieve greener, more resilient pharmaceutical systems. Specifically, this presentation will highlight several USP eco-friendly manufacturing activities and initiatives, including embedding energy efficiency into quality management systems, applying lifecycle thinking to optimize environmental performance, institutionalizing green chemistry practices, linking environmental initiatives with broader climate financing mechanisms, optimizing production output through continuous manufacturing, and improving waste reduction.
Speaker: Nenye Njoku, Project Manager, USP
Not able to join? Follow us @USPGlobalHealth for updates. #SCOMRA2025
Strengthening medicines regulatory systems
Bolstering national and regional authorities to improve access to medicines.
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Expanding manufacturing capacity
Producing medicines closer to patients improves supply chain resilience.
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