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  • info@boctre.org.bw

BoCTRe Mandate

Botswana Clinical Trial Regulation (BoCTRe) Project is a collaborating project between Botswana Medicines Regulatory Authority (BoMRA) and Ministry of Health (MoH) funded by European and Developing Countries Clinical Trials Partnership (EDCTP).

With an increase in health research, there is a greater need for ethics evaluation and regulatory oversight of clinical trials worldwide. Botswana is seeing a surge in the number and complexity of clinical studies/trials seeking approval. These trail protocols need thorough scientific and ethical examination by the National Ethics Committee (NEC), Institutional Review Boards (IRBs), and the National Regulatory Authority (NRA) to ensure the rights and wellbeing of study participants. Effective regulatory mechanisms are a prerequisite for conducting high-quality clinical studies.

That is why the Botswana Clinical Trials Regulation (BoCTRe) project came to be. The project is a joint initiative of BoMRA (NRA) and Health Research and Development Committee (HRDC), MoHW. NRA (BoMRA) and National Ethics Committee (HRDC), through this project, seek to build capacity by focusing on globally specified regulatory strengthening initiatives. The goal of BoCTRe project is to strengthen the HRDC, affiliated Institutional Review Boards (hospital-based IRBs) and NRA in order to build effective regulatory mechanisms.

This project entails developing a long-term partnership between the NEC (HRDC) and the NRA (BoMRA), as well as external partnerships to assist NEC and NRA initiatives in clinical trials oversight. The BoCTRe project is projected to result in stronger NEC and NRA capacities, more qualified personnel, and more efficient, effective, and harmonised regulatory routes for clinical trial review and monitoring.

Zambia's National Health Research Authority (NHRA) and RCORE Tanzania Medicines and Medical Devices Authority (TMDA) were engaged for assistance in the baseline assessment on clinical trials topography in the country, review and creation of SOPs, as well as assistance in the development and implementation of training materials for capacity building.

In the end the BoCTRe Project aims to achieve a sstrengthened, functional, and performing NEC and affiliated IRBs. Furthermore, Botswana will have a stronger National Ethics Committee (NEC) and National Regulatory Authority to ensure effective clinical trial regulation in Botswana. The electronic submission system, will allow for online protocol submission, tracking, and evaluation, increasing efficiency. The NEC and NRA will have effective processes in place to regulate clinical trials and will be expected to collaborate. The project facilitates regional networking via the Regional Centres of Excellence that will assist the NEC and NRA.

The project also aims to build systems, processes, and procedures. SOPs that have been reviewed and established in accordance with international standards will ensure productive and uniform evaluations. There will also be greater human capacity and capabilities for both NEC and NRA members as they learn the specialized skills necessary for clinical trial evaluation & approval, audits, and inspections of clinical trials. In essence, this grant will protect the safety, rights, and well-being of trial participants. The improved quality of the data generated will increase the trust of clinical research organizations and sponsors in coming to Botswana to conduct research. The NEC and NRA are expected to be on par with other Regional Centers by the conclusion of the grant's execution. All of this will help the initiative to accomplish SDG 3: 'Ensure healthy lives and promote well-being for all at all ages’.

This project is aimed at capacity building and strengthening of the NEC, IRBs, NRA and clinical trial investigators.
  1. To conduct a baseline assessment of clinical trials capacity for the NEC, IRBs and NRA in terms of:
    • Clinical trials approval and inspection Processes and Procedures.
    • Skills and competencies of the NEC, IRBs, clinical investigators and NRA.
    • Electronic data management system for efficient submission, review and response.
  2. To build capacity of the NEC, IRBs, NRA and investigators.
  3. To promote regional networking and benchmarking on best practices.
  4. To address emerging clinical trials components, such as, genomics, bio-banking, medical equipment and devices.
  5. To develop an electronic system to improve efficiency.
Project Title: Botswana Clinical Trials Regulation
Acronym: BoCTRe
Project Coordinator: Professor Parthasarathi Gurumurthy, Botswana Medicines Regulatory Authority (BoMRA).
Deputy Coordinator: Ms Dorcas Mgadla, Health Research and Development Committee (HRDC), MoHW.
Project start date: 1 April 2021
Duration: 24 Months
Grant Amount: EUR 281,250.00
Funding Organization: EDCTP
Direct Beneficiaries Expected impact
NEC, IRBs, Investigators and NRA Improved SOPs and guidelines, best practices, networking in the region.
Better coordination between the NEC and NRA
Indirect beneficiaries Expected impact
Research participants Safety, rights, and wellbeing of participants
Clinical research institutions Conducive environment for conducting clinical trials

About BoCTRe

Botswana Clinical Trials Regulation (BoCTRe) project is a joint initiative of BoMRA (NRA) and Health Research and Development Committee (HRDC), MoHW.

NRA (BoMRA) and National Ethics Committee (HRDC), through this project, seek to build capacity by focusing on globally specified regulatory strengthening initiatives.


Telephone +267 3914467 / 75846022 / 3731753
+267 318 6254
Plot 112, GIFP, Gaborone, Botswana