BoMRA CEO Engages Key Veterinary Industry Stakeholders On New Medicines And Related Substances Act And Draft Regulations
The Chief Executive Officer of BoMRA, Dr Seima Dijeng, convened a meeting with a select group of key veterinary industry stakeholders to discuss the draft veterinary regulations under the new Medicines and Related Substances Act (MRSA). The engagement is part of a broader, ongoing stakeholder consultation on the Medicines and Related Substances Act (MRSA and […]
BOMRA Ushers in New Era of Safer Medical Products With Landmark Regulatory Reform
The Botswana Medicines Regulatory Authority (BOMRA) is taking decisive steps to modernize the nation’s medical products landscape through the implementation of the Medicines and Related Substances Act, 2025. In a recent stakeholder engagement forum, BOMRA convened key industry players to introduce and discuss the new regulatory framework and draft regulations designed to enhance collaboration, regulatory […]
Botswana Leads Multi-Nation Fight Against Deadly Medicine Contaminants
Botswana is taking its fight against poor-quality medical products to the world stage. The Botswana Medicines Regulatory Authority (BoMRA) is hosting an expanded, hands-on training with the World Health Organisation (WHO), bringing together laboratory analysts from across Africa and, for the first time, South-East Asia. The mission of the exercise is to better detect deadly chemicals […]
NBFIRA Benchmarks BoMRA Quality Management System
The Non-Bank Financial Institutions Regulatory Authority (NBFIRA) visited the Botswana Medicines Regulatory Authority (BoMRA) for a 2-day visit to benchmark the Authority’s certified Quality Management System (QMS) and exchange insights on strengthening quality service delivery across Botswana’s regulatory bodies. The benchmarking visit follows BoMRA’s 1SO 9001 certification, awarded by the British Standards Institute (BSI) in […]
BoMRA Inducts new Board Members
The Botswana Medicines Regulatory Authority (BoMRA) has completed a comprehensive induction programme for its newly appointed Board of Directors, marking the beginning of a new stewardship journey aimed at strengthening the Athoeity corporate governance. When opening the induction programme, new Board Chairperson Dr Mpapho Motsumi welcomed the new members and reminded them of the critical […]
BOMRA Medical Devices including IVDs Regulatory Update.
BOMRA Medical Device Regulatory Strategy (2022–2030) Advancing Botswana from WHO GMRF “Basic Level of Control” to “Expanded Level” of Control 1.Strategic & Legislative EvolutionBotswana is transitioning from a basic oversight model to a comprehensive, globally aligned lifecycle regulatoryframework. Strategy Phase Legal Framework GMRF Level Strategic Focus 2022–2025 MRSA 2013 Basic Legal provisions, guidelines, processes, listing […]
Submission Of Veterinary Medicines Dossiers For The Reliance Based Expedited Registration
In line with the notice published on 13 April 2026, the Botswana Medicines Regulatory Authority (BoMRA) would like to remind all interested principals, manufacturers and potential marketing authorization holders that the submission of dossiers for the reliance based expedited review/registration pathway for veterinary medicinal products is now open, effective 1 May 2026 to 31 July 2026. For any […]
Virtual Stakeholder Engagement Medical Devices Including In Vitro Diagnostics
The Department of Product Evaluation & Registration at BoMRA will conduct virtualstakeholder sessions to discuss the medical devices including in vitro diagnostics (IVDs)processes and guidelines: registration, risk classification, labelling, clinical evaluation,registration timelines and fees. The stakeholder engagement targets all relevantstakeholders inclusive of; manufacturers, importers, distributors, local representatives,associations and facilities. The sessions will be scheduled as […]
Registration Process 18 August (002)
The Botswana Medicines Regulatory Authority (BoMRA) will be conducting a virtual stakeholder engagement to update all its valued stakeholders on Registration Processes and Procedures. The sessions will be scheduled as follows: SESSION 1: Tuesday 20 September 2022 from 0900 – 1200 hoursSESSION 2: Tuesday 20 September 2022 from 1400 – 1700 hours Please RSVP by […]
Virtual Stakeholder Engagement – Medical Devices July 2022
The Botswana Medicines Regulatory Authority (BoMRA) through the department of Product Evaluation & Registration will conduct a virtual stakeholder engagement session to update the relevant stakeholders on listing of medical devices, including In-Vitro Diagnostics (IVDs) devices.