The Botswana Medicines Regulatory Authority (BoMRA) successfully concluded a five-day assisted self-benchmarking exercise with the support of the World Health Organization (WHO) from August 11 to 15, 2025.

The assessment, conducted using the WHO Global Benchmarking Tool (GBT), reviewed all regulatory functions to guide BoMRA’s journey toward achieving WHO Maturity Level 3 (ML3). ML3 represents the global standard for an integrated, fully functional pharmaceutical regulatory system. Attaining this level will be a critical national milestone, guaranteeing even greater safety, quality, and effectiveness of medicines for everyone in Botswana. The WHO Team comprised technical officers from the Regulatory Strengthening System programme (HQ/AFRO/WCO) and independent consultants.

The August 2025 exercise followed a WHO introductory visit (pre-visit) in July 2024 to explain the WHO regulatory system strengthening (RSS) programme and the overall benchmarking process.

During the assisted self-benchmarking, which adhered to Quality Management System principles, each GBT sub-indicator was scored. This process identified strengths and existing gaps, enabling BoMRA to elaborate on the Institutional Development Plan (IDP) designed to address those gaps.

The status of the regulatory system’s maturity level was updated across the following key functions:

• National Regulatory System (RS)

• Regulatory Inspection (RI)

• Registration and Marketing Authorization (MA)

• Laboratory Testing (LT)

• Licensing Establishment (LI)

• Vigilance (VL)

• Clinical Trial’s Oversight (CT)

• Market Surveillance & Control (MC)

The assisted self-benchmarking builds on progress made following previous SADC and internal self-benchmarking activities. The overall assessment confirmed that the operationalization of all regulatory functions has made significant progress since BoMRA was established.

• The Licensing Establishment (LI) function was successfully scored at WHO Maturity Level 3 (ML3).

• The remaining functions were provisionally scored at WHO Maturity Level 1, primarily due to the pending Medicines and Related Substances Bill, 2025, which is scheduled to be tabled in Parliament in November 2025.

The assessors highlighted several operational and strategic strengths:

• A high level of technical competence across regulatory functions.

• Commitment to consistent regulatory oversight through licensing publicly owned manufacturing facilities.

• The future full institutionalization of the Botswana Integrated Information Management System (BRIMS) will deliver significant efficiencies.

• Strong political will to promulgate the MRSA Bill, underscoring the commitment to attain ML3 and beyond.

• A Strategic Plan with defined objectives, KPIs, and targets has already been drafted.

To fast-track the attainment of WHO ML3, immediate attention must be given to the following gaps:

• Legislation: The promulgation of the Medicines and Related Substances Act, 2025, and its Regulations must be finalized before the end of 2025.

• Workload Management: BoMRA must address the backlog in the Market Authorization and Registration function, which has emerged due to increased workload without a corresponding increase in staffing levels.

• System Implementation: Full implementation of the Botswana Integrated Information Management System (BRIMS) and an update to the Quality Management System are required.

Realizing these goals will require the mobilization of financial resources and ensuring staffing levels are commensurate with the regulatory mandate and workload.

During the closing session, BoMRA CEO Dr. Seima Dijeng expressed gratitude to the WHO experts and the BoMRA team for their collaborative effort. He commended the dedicated team for their commitment and hard work, emphasizing the importance of timely public access to trusted medical products.

The assessment signaled a positive outcome, indicating that the attainment of ML3 is on the horizon—a remarkable milestone for an authority that commenced operations only six years ago, in 2018. The progress reinforces BoMRA’s strategic priorities to align its regulatory framework with global health standards to safeguard public health. The journey to ML3 and beyond continues.