The World Health Organization (WHO) conducted a week-long assisted self-benchmarking exercise aimed at strengthening Namibia’s national regulatory system for medical products. Held in Windhoek from 20 to 24 October 2025, the assisted self-benchmarking used the WHO Global Benchmarking Tool (GBT) to review the maturity of the country’s regulatory functions and to identify the strengths of the system and priority areas for improvement.

The Namibia Medicines Regulatory Council (NMRC), established under the Medicines and Related Substances Control Act 13 of 2003, plays a pivotal role in regulating medical products in the country. As the Council advances toward achieving Maturity Level 3, the WHO-assisted exercise marked an important milestone by outlining strengths, identifying existing gaps and highlighting opportunities to further strengthen the regulatory system.

Over the course of five days, WHO experts worked closely with NMRC technical teams to assess eight core regulatory functions. The team reviewed the national regulatory system and marketing authorization processes to vigilance, market surveillance and the licensing of establishments.  The collaboration also extended to regulatory inspection, laboratory testing and oversight of clinical trials, creating a comprehensive picture of the country’s regulatory maturity and future needs. Through interviews, document reviews and plenary discussions, the team considered progress made since the previous self-benchmarking exercise in 2019. This collaborative process provided a clearer overview of current Maturity Level, alignment with WHO standards and areas requiring additional follow-up. The exercise also resulted in updated Institutional Development Plans (IDPs) and a road map to guide next steps.

Since 2019, a new draft Medicines and Related Substances Control Bill has been developed, significant progress has been made in drafting guidelines, standard operating procedures, and templates to support regulatory functions and an ISO/IEC 17025:2017-accredited national quality control laboratory has been established. NMRC’s commitment to transparency, digital transformation, quality management systems and reliance practices, supported by a growing technical workforce increasingly exposed to international best practices, was also noted. Several areas requiring further strengthening were also identified.

Key priorities include completing and implementing the revised Medicines and Related Substances Control Bill, strengthening workforce capacity through structured and continuous training, advancing digital and regulatory information management systems, enhancing governance and stakeholder engagement processes and reinforcing market surveillance, vigilance and inspection activities. Embedding quality management system principles and updating guidelines and regulatory procedures also remain essential next steps. The updated Institutional Development Plans for each regulatory function now serve as the foundation of Namibia’s roadmap for regulatory system strengthening, outlining key actions, timelines and areas where technical support is needed to progress toward Maturity Level 3.

As Namibia continues its efforts to reach WHO Maturity Level 3, the outcomes of this assisted self-benchmarking exercise will help guide strategic investments, capacity building and regulatory reforms. Strengthening the national regulatory system remains essential to ensuring that all medical products available in the country meet the highest standards of safety, quality and efficacy.