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Home Pharmacovigilance & Clinical Trials

Pharmacovigilance & Clinical Trials

Department of Pharmacovigilance and Clinical Trials (PVCT)

Overview

The Department of Pharmacovigilance and Clinical Trials (PVCT) is tasked with monitoring the safety of all medical products registered for use in Botswana. The department ensures that approved medicines, medical devices, and other regulated products continue to meet safety and quality standards throughout their lifecycle.

Responsibilities

Safety & Efficacy

Ensure the safety and efficacy of products to protect public and animal health.

ADRs & Vaccine Events

Monitoring adverse drug reactions and vaccine-related adverse events in humans.

Medical Devices

Surveillance of incidents related to medical devices to identify potential risks.

Cosmetics

Monitoring adverse effects of cosmetic products on the public.

Adverse Event Reporting

Collecting and analysing reports from healthcare professionals, manufacturers, and the public.

Risk Evaluation

Evaluating risks associated with medicines, vaccines, medical devices, cosmetics, and veterinary products.

Safety Measures

Implementing safety measures such as product recalls, label changes, or public warnings.

Stakeholder Awareness

Educating and engaging stakeholders on pharmacovigilance obligations and best practices.

Scope

Clinical Trials

PVCT oversees clinical trials, ensuring they are conducted ethically and in compliance with regulatory requirements.

Post-Marketing Surveillance

Post-marketing surveillance maintains the quality of registered products and prevents substandard or falsified medicines from entering the supply chain.

Processes

ADR Reporting

Collecting and analysing reports of adverse drug reactions from healthcare professionals, manufacturers, and the public. Reports are evaluated and acted upon to protect patient safety.

Clinical Trial Oversight

PVCT ensures all clinical trials conducted in Botswana are reviewed, approved, and monitored for ethical compliance and adherence to regulatory requirements throughout the trial period.

Surveillance

Ongoing monitoring of medicines, medical devices, cosmetics, and veterinary products in the market to identify and address safety signals and prevent harm.

Botswana Medicines Regulatory Authority
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