Uganda is about to advance its pharmaceutical regulatory capability and enhance native medical merchandise manufacturing in strategic partnership with the World Well being Group (WHO). This initiative follows a high-level mission from WHO’s Regulation and Prequalification Division, on the invitation of the Ministry of Well being (MoH).
The go to was led by Dr Rogério Paulo Pinto de Sá Gaspar, Director of the Regulation and Prequalification Division, along with Hiiti Sillo, Unit Head for Regulation and Security at WHO headquarters and Mohamed Ismail, the lead of Medicines Provide, Well being Infrastructure and Gear Upkeep Unit on the WHO Regional Workplace for Africa.
The 2-day mission (20-21 January 2024) introduced collectively officers of the Nationwide Drug Authority (NDA), WHO specialists, MoH officers, and key stakeholders from Uganda’s improvement companions to assessment progress on the Institutional Growth Plan (IDP). This plan, developed after the 2019 benchmarking evaluation, addresses bottlenecks and descriptions steps for reaching Maturity Stage 3 (ML3) which refers to a regulatory company that’s secure, well-functioning and built-in. Discussions centered on regulatory progress, challenges, and alternatives for enhanced collaboration between NDA and WHO.
Attaining ML3 will strengthen NDA’s capability to manage medical merchandise successfully, enhance entry to high quality medicines, and place Uganda as a pacesetter within the native manufacturing of medicines, vaccines, and medical units. The initiative aligns with WHO’s dedication to help member states in guaranteeing entry to quality-assured medicines and in the end reaching common well being protection (UHC) and well being safety.
Uganda’s well being sector faces challenges, together with gaps in regulatory oversight, restricted native manufacturing capability, and reliance on imported medical merchandise. The mission assessed Uganda’s readiness to hurry up processes and authorized formalities to realize ML3 for vaccine regulation. This aim aligns Uganda with neighbouring nations like Rwanda and Tanzania, which have already achieved ML3 for medicines and imported vaccines. The mission additionally sought to determine areas for technical help, foster intersectoral collaboration, and suggest actions to deal with present gaps.
Dr Jane Ruth Aceng Ocero, Uganda’s Minister of Well being, emphasised the significance of sturdy regulatory programs. “Strengthening our regulatory framework is essential for bettering entry to high quality medicines and reaching sustainable well being outcomes,” she famous.
Throughout the mission, NDA Authority Chairman Dr Medard Bitekyerezo highlighted the group’s dedication to regulatory excellence. “We’re centered on constructing a sturdy system that meets worldwide requirements and ensures the security and efficacy of medical merchandise for all Ugandans,” he said.
The mission included website visits to NDA amenities together with the NDA pharmaceutical laboratory prequalified by WHO. These visits underscored Uganda’s potential to enhance regulatory programs with focused investments and technical help.
Dr Gaspar reiterated WHO’s dedication to supporting Uganda. “Our position is to offer technical experience and facilitate the event of sturdy regulatory programs that guarantee the security, efficacy, and high quality of medical merchandise,” he stated.
Dr Kasonde Mwinga, the WHO Consultant to Uganda, referred to the Regional Committee decision and emphasised the position of native manufacturing in reaching well being fairness. “By constructing native capability, Uganda can guarantee a gentle provide of reasonably priced, quality-assured medicines for all,” she remarked.
Dr Aceng expressed optimism concerning the mission’s outcomes. “This collaboration marks a big step in the direction of reaching our well being sector objectives and bettering the well-being of Ugandans,” she stated.
The high-level mission go to displays Uganda’s dedication to strengthening its well being programs and WHO’s unwavering help for member states in reaching health-related Sustainable Growth Targets (SDGs). By addressing regulatory gaps and selling native manufacturing, Uganda is setting a precedent for resilience and innovation within the African well being sector.
The mission concluded with a renewed sense of dedication and readiness among the many NDA employees and board members, and Ministry of Well being officers to take crucial actions to implement the suggestions of the IDP, and as such speed up the method for Uganda to hitch the group of nations at ML3 maturity stage. WHO stays dedicated to offering technical help all through the method to make sure Uganda achieves its objectives.