Clinical trials Authorization
Department of Pharmacovigilance and Clinical Trials (PVCT)
Overview
The Botswana Medicines Regulatory Authority (BoMRA) is responsible for the regulatory oversight of clinical trials conducted in Botswana. The Authority ensures that all clinical trials are designed, conducted, monitored, and reported in accordance with the highest standards of ethics, quality, participant safety, and scientific integrity. This oversight is guided by internationally recognized principles, including the International Council for Harmonization Good Clinical Practice (GCP) Guidelines, national regulatory requirements, and global best practices, thereby promoting the protection of research participants and the generation of reliable and credible scientific data.
Responsibilities
Approval of Clinical Trial applications and Protocol Amendments
Approval of Clinical Trial applications and Protocol Amendments
Assessment of Serious Adverse Events (SAE) from Clinical trials
Evaluations of Clinical trial applications
Review of annual reports
Review of Investigator Brochure
Scope
The Clinical Trials Unit is responsible for the oversight of clinical trials and clinical investigations involving:
- Human medicines
- Veterinary medicines​
- Medicals Devices​
- Cosmetics
Processes
Post approval process
Continuous monitoring of approved clinical trials to ensure compliance
- Good clinical Practice (GCP) Inspections
- Assessment of Serious Adverse Events (SAE)
- Review of Investigators Brochure (IB)
- Review of Annual Reports
- Review of End of study Reports
Process Automation
The following are available on our BRIMS public portal:
- Application for Clinical Trials
- Application for Clinical Trial amendment
Frequently Asked Questions FAQ
What is the difference between regulatory approval and ethics approval?
Regulatory approval confirms that the clinical trial meets national regulatory requirements, including safety and scientific standards.
Ethics approval confirms that the study protects participants’ rights, dignity, confidentiality, and welfare.
Both approvals are required before a clinical trial can begin.
Who must apply for clinical trial authorization?
The sponsor or sponsor’s authorized qualifying representative is responsible for submitting a clinical trial application to the regulatory authority.
When can a clinical trial start?
Before initiating a trial, the investigator/institution should have a written and dated approval from BoMRA for the trial protocol, written informed consent form, consent form updates, participant recruitment procedures (e.g., advertisements), and any other written information intended to be provided to trial participants. And after Ethics approval has been obtained.
What documents are required for a clinical trial application?
Refer to Check list for Clinical Trial application, available on the website.
What happens if there is a change to an approved clinical trial?
Applications for amendments to clinical trial protocols and investigational product/s shall be submitted to BoMRA for approval prior to their implementation using Application for Clinical Trial Amendment Protocol form BOMRA/PCT/CT/P01/F02 with the prescribed fee. Details are available in the Guideline for Clinical Trial Application and Authorization in Botswana section 6.8.1 Clinical Trial Amendments:
What are the reporting timelines for Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reaction (SUSAR)?
Fatal or life-threatening SAEs should be reported to BoMRA within 24 hours by e-mail followed by a complete report within 72 hours.
Are clinical trials inspected?
Yes. BoMRA shall conduct clinical trial inspections to monitor clinical trials from start to finish as per inspection plan. Inspections may be routine or may be triggered by a cause like issues arising during the assessment of annual reports, protocol amendments, or by other information such as previous inspection experience. BoMRA may inspect the study site(s), the sponsor or the manufacturer of the medical products, to ensure compliance with GCP and the inspection may be done with/without notification. BoMRA and NEC (HRDC) may conduct combined inspections from time to time.
What happens if a clinical trial does not comply with requirements?
BoMRA may take regulatory enforcement/legal action. Example: Requesting corrective actions, suspending recruitment and Suspending or terminating trial.
How long does clinical trial approval take?
The review and approval process in Botswana is expected to take up to 90 working days from the time the completed application is received by BoMRA for approval. This timeline excludes the time when the applicant is addressing the queries raised. We encourage all applicants to work in coordination with BoMRA to enable the achievement of these timelines. Clinical trials for emergency preparedness, the expedited timeline for review and approval may be reduced to 15 working days subject to early submission of a complete application.
Can a clinical trial be conducted without regulatory approval?
No. Conducting an unauthorized clinical trial is a regulatory violation and may result in enforcement actions.
The conduct of the trial shall be approved by the National Medicines Regulatory Authority (BoMRA) and the Health Research and Development Committee (National Ethics Committee).
Where can applicants submit clinical trial applications?
Applicants should submit applications online through BRIMS, the system link is provided on the website.
When to Submit an Application to Conduct a Clinical Trial?
Before initiating the clinical trial (s), the sponsor (or the sponsor and the investigator, is required to submit the required application (s) to BoMRA for review, acceptance, and/or permission to conduct the trial(s). The submission should be dated, signed by the Principal Investigator, and contain sufficient information as detailed under clinical trial application checklist.