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Gambia
Guideline for the National Pharmacovigilance System
This guideline outlines the organizational structure and principles of The Gambia’s National Pharmacovigilance System, as established by the Medicines Control Agency (MCA). It defines the system’s core components, including the National Pharmacovigilance Centre within the MCA, the Medicines Safety Experts Committee (MSEC), and regional focal persons. The document details the specific roles and responsibilities of each stakeholder, from the MCA’s function in processing reports and taking regulatory action to the MSEC’s role in technical evaluation and the obligations of Marketing Authorisation Holders and healthcare facilities.
Use Cases
- Medicines Control Agency (MCA) – Lead the National PV System: To act as the National Pharmacovigilance Centre, coordinating all pharmacovigilance activities, processing safety reports, conducting risk assessments, and implementing regulatory actions.
- Medicines Safety Experts Committee (MSEC) – Provide Technical Expertise: To review and evaluate all safety reports submitted to the MCA, provide expert technical advice, and make recommendations for regulatory action based on evidence.
- Health Facilities and Regional Focal Persons – Facilitate Data Collection: To serve as frontline data sources for adverse reaction reports from consumers and patients, and to forward these reports to the MCA for national-level analysis.
- Marketing Authorisation Holders (MAHs) – Appoint a Qualified Person for PV (QPPV): To have a registered healthcare professional resident in The Gambia who is formally trained in pharmacovigilance to act as the QPPV, responsible for the MAH’s PV obligations.
- Healthcare Professionals – Contribute to Patient Safety: To actively participate in the system by reporting suspected adverse reactions, which helps reduce suffering, save patients’ lives, and fulfill their professional responsibility.
- Consumers and the General Public – Initiate the Reporting Process: To report any suspected adverse events to their healthcare providers, thereby triggering the formal reporting process and contributing to the overall safety of medicines.
Key takeaways you'll learn
The resource’s purpose is to define the structure, goals, and operational framework of The Gambia’s National Pharmacovigilance System, clarifying the roles and responsibilities of all key stakeholders to ensure a coordinated national effort in monitoring medicine safety.
- Centralized Structure: The National Pharmacovigilance System is centrally organized, with the Medicines Control Agency (MCA) acting as the National Pharmacovigilance Centre, which is the core of all activities.
- Expert Advisory Body: A key component of the system is the Medicines Safety Experts Committee (MSEC), an independent technical body responsible for reviewing safety reports and providing recommendations to the MCA on regulatory actions.
- Mandatory QPPV for MAHs: The guideline mandates that all Marketing Authorisation Holders must have a Qualified Person for Pharmacovigilance (QPPV) who is a registered healthcare professional resident in The Gambia and formally trained in PV.
- Multi-Source Data Collection: The system is designed to collect safety data from multiple streams, including spontaneous reports from healthcare professionals, systematic surveillance from public health programs, and mandatory reports from Marketing Authorisation Holders.
- Clear Delineation of Roles: The document meticulously outlines the specific responsibilities of each actor in the system, from the MCA’s coordinating and regulatory role to the frontline data-gathering function of health facilities and the reporting obligations of MAHs.
