The story of the Botswana Medicines Regulatory Authority (BoMRA) is one defined by transformation and an unwavering commitment by the Government of Botswana to safeguard and promote public health. It reflects the Government’s deliberate and strategic journey toward establishing a modern, credible, and trusted regulatory system—one that ensures all medical products available within the country meet the highest standards of safety, quality, and efficacy.

For many years, Botswana’s medicines regulatory function was housed within Government as the Drug Regulatory Unit (DRU) under the Ministry of Health and Wellness, operating under the Drugs and Related Substances Act of 1992. While this framework provided an important foundation for oversight, the increasing complexity of medical products and the need for enhanced regulatory capacity necessitated a more robust, independent system.

A defining milestone was reached in 2013 with the enactment of the Medicines and Related Substances Act (MRSA). This legislation transformed the regulatory landscape by establishing BoMRA as a statutory authority, equipped with a clearer mandate, strengthened legal powers, and governance structures aligned with international best practice.

BoMRA became fully operational in 2018, marking a significant transition from a Ministry-based unit to an independent regulator with national responsibility. The Authority assumed oversight of both human and veterinary medical products, consolidating functions that had previously been distributed across health and animal health systems into a single, coordinated regulatory framework.

Today, BoMRA stands as key player of Botswana’s public health system, performing all eight World Health Organization (WHO) core regulatory functions , though the global benchmark for an effective and mature regulation,  The Authority continues to advance under the modernised MRSA framework, its focus remains firmly on strengthening regulatory systems, enhancing stakeholder confidence, and protecting the health and well-being of all people in Botswana because trust in every medical product begins with trust in the system that regulates it.