Uganda is set to advance its pharmaceutical regulatory capacity and boost local medical products production in strategic partnership with the World Health Organization (WHO). This initiative follows a high-level mission from WHO’s Regulation and Prequalification Department, at the invitation of the Ministry of Health (MoH). 

The visit was led by Dr Rogério Paulo Pinto de Sá Gaspar, Director of the Regulation and Prequalification Department, together with Hiiti Sillo, Unit Head for Regulation and Safety at WHO headquarters and Mohamed Ismail, the lead of Medicines Supply, Health Infrastructure and Equipment Maintenance Unit at the WHO Regional Office for Africa. 

The two-day mission (20-21 January 2024) brought together officials of the National Drug Authority (NDA), WHO experts, MoH officials, and key stakeholders from Uganda’s development partners to review progress on the Institutional Development Plan (IDP). This plan, developed after the 2019 benchmarking assessment, addresses bottlenecks and outlines steps for achieving Maturity Level 3 (ML3) which refers to a regulatory agency that is stable, well-functioning and integrated. Discussions focused on regulatory progress, challenges, and opportunities for enhanced collaboration between NDA and WHO.

Achieving ML3 will strengthen NDA’s capacity to regulate medical products effectively, improve access to quality medicines, and position Uganda as a leader in the local production of medicines, vaccines, and medical devices. The initiative aligns with WHO’s commitment to support member states in ensuring access to quality-assured medicines and ultimately achieving universal health coverage (UHC) and health security. 

Uganda’s health sector faces challenges, including gaps in regulatory oversight, limited local production capacity, and reliance on imported medical products. The mission assessed Uganda’s readiness to speed up processes and legal formalities to attain ML3 for vaccine regulation. This goal aligns Uganda with neighbouring countries like Rwanda and Tanzania, which have already achieved ML3 for medicines and imported vaccines. The mission also sought to identify areas for technical assistance, foster intersectoral collaboration, and propose actions to address existing gaps. 

Dr Jane Ruth Aceng Ocero, Uganda’s Minister of Health, emphasized the importance of robust regulatory systems. “Strengthening our regulatory framework is crucial for improving access to quality medicines and achieving sustainable health outcomes,” she noted. 

During the mission, NDA Authority Chairman Dr Medard Bitekyerezo highlighted the organization’s commitment to regulatory excellence. “We are focused on building a robust system that meets international standards and ensures the safety and efficacy of medical products for all Ugandans,” he stated. 

The mission included site visits to NDA facilities including the NDA pharmaceutical laboratory prequalified by WHO. These visits underscored Uganda’s potential to improve regulatory systems with targeted investments and technical support. 

Dr Gaspar reiterated WHO’s commitment to supporting Uganda. “Our role is to provide technical expertise and facilitate the development of robust regulatory systems that ensure the safety, efficacy, and quality of medical products,” he said. 

Dr Kasonde Mwinga, the WHO Representative to Uganda, referred to the Regional Committee resolution and emphasized the role of local production in achieving health equity. “By building local capacity, Uganda can ensure a steady supply of affordable, quality-assured medicines for all,” she remarked. 

Dr Aceng expressed optimism about the mission’s outcomes. “This collaboration marks a significant step towards achieving our health sector goals and improving the well-being of Ugandans,” she said. 

The high-level mission visit reflects Uganda’s dedication to strengthening its health systems and WHO’s unwavering support for member states in achieving health-related Sustainable Development Goals (SDGs). By addressing regulatory gaps and promoting local production, Uganda is setting a precedent for resilience and innovation in the African health sector. 

The mission concluded with a renewed sense of commitment and readiness among the NDA staff and board members, and Ministry of Health officials to take necessary actions to implement the recommendations of the IDP, and as such accelerate the process for Uganda to join the group of countries at ML3 maturity level. WHO remains committed to providing technical support throughout the process to ensure Uganda achieves its goals.