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Botswana Medicines Regulatory Authority (BoMRA) and Medicines Control Authority of Zimbabwe Strengthen Cooperation Through MoU Renewal

Botswana Medicines Regulatory Authority (BoMRA) and Medicines Control Authority of Zimbabwe Strengthen Cooperation Through MoU Renewal

MOU Signing

Botswana Medicines Regulatory Authority (BoMRA) and Medicines Control Authority of Zimbabwe Strengthen Cooperation Through MoU Renewal

10th August 2023

Botswana Medicines Regulatory Authority (BoMRA) and Medicines Control Authority of Zimbabwe Strengthen Cooperation Through MoU Renewal

Zimbabwe, Harare: The Botswana Medicines Regulatory Authority, (BoMRA) has renewed its Memorandum of Understanding with the Medicines Control Authority of Zimbabwe, (MCAZ). This renewal strengthens a long-standing partnership between the two nations in the critical area of medicine and medical device regulation.

The renewed MOU focuses on several key areas of collaboration such as: Exchange of Information and Expertise: Both organizations share knowledge on Quality Management Systems, including ISO standards for laboratories and good manufacturing practices for pharmaceuticals. Capacity Building: The agreement facilitates regulatory excellence and professional development through system audits, training, and capacity building exercises. Mutual Support: both authorities will assist each other in strengthening their regulatory processes, benefiting from each other’s experiences and best practices.

It’s worth noting that MCAZ brings significant expertise to this partnership. In 2014, it was designated a Regional Centre of Regulatory Excellence under the African Medicines Regulatory Harmonization initiative. MCAZ offers specialized knowledge in areas such as Evaluation and Registration of medicines, Pharmacovigilance and Clinical trials, and Laboratory testing. MCAZ further achieved Maturity Level 3 as assessed against the World Health Organisation Global Benchmarking tool. BoMRA aspires to achieve Maturity Level 3 which assures that the regulators functions are carried out in alignment with the best practices and having MCAZ as a partner will support BoMRA’s efforts to do so, said BoMRA CEO, Dr. Seima Dijeng.

The agreement includes provisions for confidentiality, ensuring that sensitive information shared between the authorities is protected. This collaboration is expected to enhance the efficiency of medicine registration processes, improve the quality of regulatory decisions, and ultimately ensure better access to safe, high-quality medicines and medical devices for the people of Botswana and Zimbabwe.

The renewal of this MOU reflects a shared commitment to public health and regulatory excellence in our region. It’s a significant step towards harmonizing and strengthening our regulatory systems, which will benefit not just Botswana and Zimbabwe, but potentially the wider Southern African Development Community, concluded the BoMRA CEO.
–ENDS–

For more information, please contact Public Relations: info@bomra.co.bw and or pr@bomra.co.bw TEL: 373 17 27 / 3731728.

NOTES TO THE EDITOR

About BoMRA

BoMRA was established through the Medicines and Related Substances Act to ensure that all human and veterinary medicines, medical devices, cosmetics and related substances conform to the set standards of quality, safety and efficacy.

Medicine regulation in Botswana continues to evolve and as such it is upon the Authority to ensure that it executes its mandate of delivering quality and transparent market authorization services, with the aim of reducing incidents of substandard and falsified medicines and related substances and creating awareness and improved trust to the general public, stakeholders and the health industry in medicines and related substances regulatory systems in Botswana.

About MCAZ

Medicines Control Authority of Zimbabwe (MCAZ) is a statutory body established by an Act of Parliament, The Medicines and Allied Substances Control Act (MASCA) [Chapter 15.03]. MCAZ is a successor of the Drugs Control Council (DCC) and the Zimbabwe Regional Drug Control Laboratory (ZRDCL). DCC was established by an Act of Parliament in 1969: Drugs and Allied Substances Control Act [Chapter 15.03] following which ZRDCL became operational in 1989. MCAZ is responsible for protecting public and animal health by ensuring that accessible medicines and allied substances and medical devices are safe, effective and of good quality through enforcement and adherence to standards by manufacturers and distributors. The mandate of MCAZ is to protect public health ensuring that medicines and medical devices on the market are safe, effective, and of good quality.

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BoMRA Background

The Botswana Medicines Regulatory Authority (BoMRA) Was established through the Medicines and Related Substances Act of 2013. The MRSA Authorises BoMRA to perform functions given by the shareholder – The Government of Botswana. The MRSA of 2013 replaced the repealed Drugs and Related Substances Act No.

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Dr. Seima Dijeng

Dr Seima Dijeng is the Acting CEO of BoMRA. Before assuming the acting appointment role, he served as the Director of Licensing and Enforcement, overseeing inspections and licensing of premises, laboratory services, import and export control, and enforcement.

A career regulatory professional with over 15 years of experience across both the food and pharmaceutical sectors. He has been part of the BoMRA executive management since 2018.

During his tenure as the Director, he coordinated the development of structures, processes, and guidelines to support regulatory activities and services for the licensing and enforcement department.

He holds a Master of Science in Food, Safety, and Risk Analysis from University College Dublin, the Republic of Ireland, Bachelor of Veterinary Science, from the University of Queensland in Australia.

Dr. Kefentse Motshegwa

Dr. Motshegwa is the Director of Veterinary Services at the Ministry of Agriculture. His illustrious career in veterinary services spans over 23 years in various positions within the veterinary space.

He previously served as Deputy Director – Compliance at the Department of Veterinary Services, Chairperson of the National Residue Committee, and Coordinator of Performance of Veterinary Services Evaluation for the World Organisation for Animal Health founded as OIE.

He brings to the Board a wealth of experience in compliance and regulation in animal health, food safety & veterinary medicines. He is a member of the Botswana Vaccine Institute Board of Directors.

He holds a Master of Science in Biology and Control Parasitic Diseases and Vectors from the University of Liverpool, School of Tropical Medicine, and a Bachelor of Veterinary Medicine from the University College Dublin, Ireland

Dr. Ditiro Duma Coyne

Dr. Coyne is a veterinarian with a career spanning over 15 years in mixed private practice in Gaborone. He has been actively involved in animal welfare and has been the veterinary advisor to the Botswana Society for the Prevention of Cruelty to Animals for several years.

He was the President of the Botswana Veterinary Association for 8 years and has made great strides in advancing Continuous Professional Development for Veterinarians in the country. He brings to the Board vast experience in veterinary education and advocacy as well as Animal Health and Production.

He is currently the World Small Animal Veterinary Association Country Representative for Botswana.

He holds a Bachelor of Veterinary Medicine and Surgery, and a Bachelor of Sciences Veterinary Biology both from Murdoch University, Australia.

Ms. Elizabeth Kelentse

Ms. Kelentse is the Pharmaceutical Care Improvement Specialist at the Botswana-University of Maryland School of Medicine Health Initiative.

She is an enthusiastic and hardworking Pharmacist who brings vast experience to the Board. Her career spans over 12 years from clinical pharmacy to community pharmacy, medicines regulatory experience in the evaluation of clinical trials protocols, and pharmacovigilance: health care management and public health programming.

She has served on the executive committees of the Pharmaceutical Society of Botswana, Botswana Health Professions Council, Young African Leaders Initiative Alumni as well as the National Adverse Events Following Immunisation.

She holds a Bachelor of Science (Pharmacy) University of West Indies St Augustine, Trinidad & Tobago.

Ms. Matshediso Matome

Ms. Matshediso Matome is a Faculty of Health Sciences lecturer at the University of Botswana. She is a seasoned academic who brings to the Board vast experience in the areas of research, health risk management, and delivery of innovative, quality, and cost- effective healthcare solutions for the public and private sectors.

Ms. Matome has previously served in various leadership and senior management positions, including Claims Manager and Head of Managed Care at the Associated Fund Administrators.

She holds a Master’s degree in Pharmacology and Toxicology from, the State University of New York Buffalo, NY, USA, and a Bachelor of Pharmacy, from Albany College of Pharmacy, Albany, USA

Dr Kobedi Segale

Dr. Segale is the Registrar of the Veterinary Surgeons Council. He is a passionate veterinary surgeon with intimate experience in the regulation of the veterinary profession. He has previously served as Deputy Director – Disease Control Division, in the Department of Veterinary Services, responsible for national animal health strategies, programs, and legislation. Dr. Segale brings to the Board a wealth of experience in monitoring and evaluating animal health programs veterinary public health, import and export controls, and animal traceability.

He holds a Master of Science in Tropical Animal Health, from the Institute of Tropical Medicine, Antwerpen, Belgium, and a Bachelor’s degree in Veterinary Medicine from the University College of Dublin, Ireland.

Ms. Mmama Mhlanga – Fichani

Ms. Mhlanga – Fichani is the Vice President, Human Resources and Communications, at Khoemacau Copper Mining. She is a human resources professional with an illustrious career, spanning over15 years in senior management positions. She has held senior leadership positions in diverse industries including, Director of Human Resources at Air Botswana and the Country Head of Human Resources at Standard Chartered Bank Botswana, Head of Human Resources at Be Mobile, Human Resources Manager at African Comprehensive HIV/AIDS Partnership and Human Resource Manager at Non-Bank Financial Institutions Regulatory Authority, respectively.

She brings to the Board vast experience in human resources and communication, organisational effectiveness, employee relations, and change management.

Ms. Mhlanga – Fichani holds a Master’s Degree in Business and Workforce Development from the University of Pennsylvania, USA, a Bachelor of Science in Business Management Human Resources Management, and Marketing Management, from Fairmont College, West Virginia USA, and a Degree of Associate of Science in Business Science- Human Resources Management, September, Calhoun State Community College, Decatur, Alabama, USA.

Mr. Modisa Kebonyemodisa

Mr. Kebonyemodisa is a Partner at Kebonyemodisa Law Office, he is admitted attorney of the High Court of Botswana. Before venturing into private practice, he worked as a Senior Prosecution Counsel at the Directorate of Public Prosecutions.

Mr. Kebonyemodisa is an accomplished legal advisor with over 15 years of experience providing legal counsel to businesses of all sizes. He brings to the Board vast experience in legal practice, corporate law, and extensive knowledge in the legal profession.

He holds a Bachelor of Law degree from, the University of Botswana and Trial Advocacy, Justice Advocacy Training (NITA) (Botswana)

Ms. Tiny Ralefala

Ms. Ralefala is a finance professional with a proven record of leadership, corporate governance, and risk management.

Her impressive professional track record spans over 26 years in finance, audit and accounting in reputable institutions as well as in civil service.

She previously worked as the Chief Finance Officer for Citizen Entrepreneurial Development Agency. Prior to her joining Citizen Entrepreneurial Development Agency she worked as the Finance Manager at the Motor Vehicle Accident Fund.

As a Chartered Financial Accountant, Ms. Ralefala brings to the Board a wealth of experience accustomed to managing projects in finance, audit and risk. She holds a Bachelor of Commerce degree from the University of Botswana. Ms. Ralefala is a fellow member of the Association of Chartered Accountants and the Botswana Institute of Chartered Accountants. She is the current Botswana Institute of Chartered Accountants Practice Review Committee Chairperson.

Dr. Lorato Mangadi-Mokama

 Dr. Lorato Mangadi- Mokama is the  Head of Operations at the Botswana Public Officers Medical Aid Scheme.
She has previously held other  leadership roles within the private healthcare industry, including Chief Operations Officer at the Botswana Medical Aid Society and Managing Director at MRI Botswana Limited. Prior to that, she practiced as a medical doctor in the public health sectors of Australia and Botswana.

Healthcare administrator and funding expert, with her extensive background in the private healthcare industry, she brings to BoMRA a wealth of experience and knowledge in business management and leadership.

She holds a Bachelor of Medicine from the University of Newcastle (Australia) and a Master of Business Administration from the University of Botswana.

She also has various leadership and professional certifications including Executive Leadership Program from Wits Business School and Healthcare Economics from Harvard Business School

Dr. Kegomoditswe Biki Maphane

Dr Kegomoditswe Biki Maphane is the Senior Manager – Safety and Sustainability Development at Debswana Diamond Company, Jwaneng Mine. He is a specialist in Occupational Medicine, Safety & Sustainable Development.

He has held various positions within the Debswana mines, including the Jwaneng Mine Hospital superintendent, and rose to executive leadership.

Dr Maphane provides leadership to the BoMRA Board and oversees the governance and strategic direction of the Authority. He holds a Bachelor of Medical Sciences, and Bachelor of Medicine / Bachelor of Surgery from the University of Melbourne, Australia