WHO Supports Uganda's Efforts to Achieve Maturity Level 3 Status for Drug Regulation

The  National Drug Authority (NDA) is seeking to overcome legal and regulatory challenges that have hindered its progress toward achieving Maturity Level 3, a global standard for drug regulators.

The concern was raised during a recent engagement with a high-level delegation from the World Health Organization (WHO), led by Prof. Rogerio Gaspar, Director of the Regulation and Pre qualification Department at WHO Geneva.

A two-day meeting between the WHO team, Uganda's Ministry of Health, and the NDA focused on addressing the technical and legal steps needed to reach this critical milestone.

Maturity Level 3, which is a key benchmark for drug regulatory bodies, ensures that national authorities can effectively oversee drug safety, efficacy, and quality, aligning with international norms.

Only eight African countries have currently attained this status, making it a significant goal for Uganda. These include , Egypt, Rwanda, Senagal, Ghana, Nigeria, South Africa, Tanzania and Zimbabwe.

Prof. Gaspar praised Uganda’s progress, particularly highlighting the NDA’s Quality Control Laboratory, which has received top international ratings.

“The NDA’s systems and operations already meet international standards, particularly in its laboratory work,” Prof. Gaspar noted.

However, he emphasised that legal and regulatory reforms are necessary before the NDA can officially achieve Maturity Level 3.

Despite these strong technical capabilities, Uganda’s outdated regulatory framework is preventing the NDA from meeting all the necessary criteria.

According to the WHO team, certain clauses within the existing national law are unfavourable and pose obstacles to regulatory improvements.

These legal limitations are holding back Uganda’s full potential as a leader in drug regulation.

Ugandan health authorities are aware of the challenges and expressed the government’s commitment to addressing them.

The WHO’s support is crucial in helping Uganda strengthen its regulatory systems, which will, in turn, enhance the safety and quality of medicines available to Ugandan citizens.

This progress is expected to contribute significantly to improving public health across the country, ensuring better health outcomes for the population.

The collaboration between Uganda’s Ministry of Health, the NDA, and the WHO marks an important stride towards achieving Maturity Level 3 status, positioning Uganda to play a pivotal role in drug regulation on the African continent.