From The Coordinators

 

The Coordinator (Professor Parthasarathi Gurumurthy)

Botswana Medicines Regulatory Authority (BoMRA) works to guarantee that all medicines, medical devices and related substances used in Botswana meet defined quality, safety, and efficacy requirements. Regulation and oversight of clinical trials conducted in Botswana is one of the important functions of BoMRA. 

 

BoMRA in collaboration with The Ministry of Health and Wellness through the Health Research and Development Division are implementing Botswana Clinical Trials Regulation (BoCTRe) project funded by European & Developing Countries Clinical Trials Partnership (EDTCP). Through the implementation of this project, we aim to strengthen capacities of National Ethics Committee (Health Research and Development Committee (HRDC), Institutional Review Boards (IRBs) as well as BoMRA, the National Regulatory Authority (NRA) to establish strong regulatory procedures. This is an essential foundation for conducting quality clinical trials in Botswana. The BoCTRe project aims to improve the efficiency of the functioning of NEC and NRA and to increase capacity by concentrating on internationally defined regulatory strengthening initiatives.

Implementation of electronic data management system for efficient submission, review and response of clinical trial applications is an important element of this project.  The introduction of innovative systems, technologies, and reliance practices through BoCTRe project would facilitate the various functions of BoMRA and HRDC with better quality outputs and improved timelines. Furthermore, the project seeks to also strengthen linkages between ethics and regulatory functions with other important structures, such as clinical trial registries whilst simultaneously enforcing the sharing of data in compliance with global requirements.

 

 Deputy Coordinator (Ms Dorcas Mgadla)

We commit ourselves to promote health research in order to achieve good health and wellbeing as outlined in the Sustainable Development Goals. One of the pillars of health research is Clinical Trials. There has since been an increase in the conduct of clinical trials in Botswana, thus it is imperative to strengthen the capacity of the National Ethics Committee (HRDC), National Regulatory Authority (BoMRA) and the Institutional Review Boards (IRBs). By doing so, we will avert the challenges that may arise in the future. Therefore, the Botswana Clinical Trials Regulation (BoCTRe) project was birthed, supported by European and Developing Clinical Trials Partnership.

Research ethics is governed by local, regional and international codes of ethics and standards and the Government of Botswana has subscribed to those. These include among others, the Nuremburg Code, the CIOMS, Declaration of Helsinki and The Standard Operating Procedures for conduct of Bio-Behavioral and Bio-Medical Research in Botswana. Adherence to these standards and guidelines is critical so as to ensure that human participants are protected to the highest ethical standards possible. Moreover, we must always be on the lookout that risks to human participants do not outweigh potential benefits.

Therefore, I am confident that completion of this project will assist in building strong and competent ethics and regulatory functions in Botswana.

Always remember – “Respect, Beneficence, and Justice”.

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