Rwanda has set a strategic vision to become a regional hub for high-quality services, including healthcare and pharmaceutical manufacturing. The COVID-19 pandemic exposed significant global inequalities in access to vaccines, medicines, and other health products, highlighting the urgent need for African countries to strengthen local production capacity and reduce reliance on imports. As Rwanda advances its ambition to manufacture vaccines and essential medicines, including through partnerships such as BioNTech’s mRNA vaccine initiative, a strong and internationally recognized regulatory system is essential to ensure the safety, quality, and efficacy of health products.

The Rwanda Food and Drugs Authority was established only in 2018. Remarkably, the authority has already attained Maturity Level 2 on the World Health Organization’s Global Benchmarking Tool (WHO GBT), the second highest of four tiers. This level represents the baseline required for a stable regulator to oversee vaccine production. However, significant challenges persist: many processes remain paper-based, hundreds of files await review, and skilled experts are still in short supply.

Self-reliance

Kwigira means “self-reliance” in Kinyarwanda. Running from 2022 to 2027, the project aims at strengthening the national regulator so that the agency reaches level three (WHO GBT ML3). In turn, Rwanda attracts pharmaceutical investors, and Africans gain access to safe and effective products.

The project acts on four fronts. This effort coaches staff in reviewing products, inspecting factories, monitoring side effects and overseeing clinical trials. The initiative helps modernise laws and regulations to meet international standards. Digitisation streamlines the authority’s work and tracks medicines from factory to patient. Finally, the project equips the quality control laboratory and supports a master’s programme in biotechnology.

Belgian expertise

Enabel implements the project with the Ministry of Health, the Rwanda Food and Drugs Authority and the University of Rwanda. Belgian public experts share their know-how. These partners include Sciensano, the Federal Agency for Medicines and Health Products and the Institute of Tropical Medicine. The non-profit expert network Quamed also contributes. Rwandan institutions lead, while partners support.

Real change is expected. Rwandan regulators will decide faster and with greater confidence. Patients will be better protected from falsified and harmful products. Health workers will report side effects more easily. A new generation of Rwandan scientists, women and men alike, will serve both regulation and industry. Investors will find a reliable partner.

Without a strong regulator, local production would stall and dangerous products would keep circulating. With one, Rwanda protects its 13 million people and serves the whole region. Kwigira is about health sovereignty, dignity and an equal partnership between Africa and Europe.

The European Union finances Kwigira with 7 million euros. This funding forms part of the Team Europe initiative on vaccines and medicines in Africa.