A Journey to WHO Maturity Level 3 – Strengthening Our National Regulatory System for Global Health Impact

The narrative of the Rwanda Food and Drugs Authority (Rwanda FDA) is one of commitment, innovation, and collaborative partnerships, culminating in our recent achievement of the World Health Organization (WHO) Maturity Level 3 in December 2024.

Recognised globally as a benchmark for regulatory excellence, this milestone marks a major step in Rwanda’s journey toward a resilient health system and the realization of Vision 2050 which aims to position Rwanda as a regional hub for pharmaceutical manufacturing and Agro-processing.

Establishment and Initial Capacity Building: Laying the Foundation

The Rwanda FDA was officially established in 2018 with the mandate of protecting public health through the regulation of human and veterinary medicines, vaccines and other biologicals, medical devices and in-vitro diagnostics, processed food products, cosmetics, and other health products to ensure their quality, safety, and efficacy for the Rwandan population. However, like any new institution, the initial phase focused on laying strong regulatory foundations and building institutional capacity.

Gradually, Rwanda FDA transitioned into a more structured institution. By 2021, we embarked on the rigorous journey towards achieving WHO Maturity Level 3 status—a milestone that would transform the Rwanda FDA into a globally recognised, robust regulatory authority, capable of safeguarding health products, fostering innovation, and contributing to Rwanda’s broader economic growth.

Reflecting on our beginnings in 2018, the Rwanda FDA was established as a necessary response to Rwanda’s vision of strengthening agri-food and pharmaceutical production and manufacturing. From the outset, achieving a robust regulatory system to safeguard public health and support national and regional development priorities was a key objective, and attaining an internationally recognised level of maturity and accreditation became a priority.

Today, I take pride in recounting the journey we have undertaken to achieve WHO Maturity Level 3 —a journey defined by dedication, teamwork, and strategic partnerships.

The Road to WHO Maturity Level 3: A Rigorous Three-Year Process

Achieving WHO Maturity Level 3 is a significant accomplishment. It indicates that a regulatory authority has established a stable, well-functioning, integrated and internationally recognised system capable of effectively ensuring the quality, safety, and efficacy of medical products.

To achieve this, Rwanda FDA followed a clear roadmap along with support programs that were implemented with a strong collaboration with international partners and medicines regulatory bodies. Importantly, the Government of Rwanda’s unwavering support was instrumental throughout this process.

Strengthening Rwanda FDA: A Pillar of Vision 2050

The attainment of WHO Maturity Level 3 is not merely a regulatory milestone; it represents a crucial advancement in Rwanda’s long-term development agenda. Under Vision 2050, Rwanda aims to establish itself as a hub for pharmaceutical manufacturing, research and development, and agro-processing in Africa. A robust and efficient regulatory system is fundamental to this vision, ensuring that locally manufactured health products meet international quality standards and fostering Rwanda’s competitiveness in regional and global markets.

Lessons Learned

Reflecting on this journey, several key lessons emerge:

Strong Political Will and Leadership: The Government of Rwanda’s dedication to supporting Rwanda FDA was a significant factor in our success.

Strategic Partnerships: Collaboration with Maturity Level 3 and advanced regulatory agencies highlighted the effectiveness of partnerships in accelerating progress.

Institutional Dedication: The commitment and diligence of Rwanda FDA staff were crucial in navigating the stringent requirements of the WHO benchmarking process.

The Path Forward

As we celebrate this achievement, we also acknowledge that the journey does not conclude here. WHO Maturity Level 3 is a foundation upon which we will continue to build. Our next objective is to achieve WHO Maturity Level 4, which will further enhance our capabilities and solidify our position as a regional leader in regulatory excellence.

South-to-South collaboration remains a fundamental aspect of our philosophy, and we are committed to sharing our experiences with other countries working toward strengthening their regulatory frameworks.

Conclusion

The Rwanda FDA’s achievement of WHO Maturity Level 3 is a testament to what can be accomplished through vision, collaboration, and determination. This milestone reinforces Rwanda’s commitment to safeguarding public health, advancing pharmaceutical innovation, and driving economic growth.

As we move forward, we remain guided by the principles of excellence, resilience, and partnership to ensure that our regulatory system not only meets global standards but also serves the health and prosperity of Rwanda and beyond.