Fill out the form below to receive the complete PDF guide directly in your inbox. This resource provides clear, step-by-step guidance to help you make the most of the information we’ve prepared for you.
Gambia
Guideline for Safety Monitoring of Medicines (Pharmacovigilance) including Vaccines
This guideline details the comprehensive safety monitoring obligations for Marketing Authorisation Holders (MAHs) in The Gambia. It mandates the appointment of a Qualified Person for Pharmacovigilance (QPPV) and outlines requirements for submitting key safety documents, including Periodic Safety Update Reports (PSURs/PBRERs) and Risk Management Plans (RMPs). The document also provides a framework for conducting Post-Authorisation Safety and Efficacy Studies (PASS/PAES), managing safety communications, and implementing enhanced vigilance during public health emergencies, ensuring continuous oversight of a product’s risk-benefit profile.
Use Cases
- Marketing Authorisation Holders (MAHs) – Appoint a Qualified Person for PV (QPPV): To designate and have at their disposal a healthcare professional resident in The Gambia, registered with a statutory council and formally trained in PV, to be responsible for all pharmacovigilance tasks.
- MAHs and their National Representatives – Submit Periodic Safety Update Reports (PSURs): To submit PSURs/PBRERs to the MCA every six months for the first two years a product is on the market, and then annually, to provide an updated assessment of the product’s risk-benefit balance.
- Applicants for Marketing Authorisation – Prepare and Submit a Risk Management Plan (RMP): To develop and submit a detailed RMP as part of the marketing authorisation application, identifying safety concerns and outlining measures to prevent or minimize risks.
- MAHs – Conduct Post-Authorisation Studies (PASS/PAES): To conduct post-authorisation safety or efficacy studies, either voluntarily or when imposed by the MCA, to investigate a safety concern or verify a product’s long-term effectiveness.
- MAHs and Manufacturers – Manage Safety Communications: To obtain prior approval from the MCA before issuing any safety communications (e.g., direct healthcare professional communication, press releases) to ensure the information is accurate and not misleading.
- All Stakeholders – Enhance Vigilance During Public Health Emergencies: To follow the specific safety monitoring plan for medicines under Emergency Use Authorisation (EUA), including reporting all ADRs within 24 hours of detection, to facilitate early signal detection.
Key takeaways you'll learn
The resource’s purpose is to provide Marketing Authorisation Holders with a detailed framework of their legal obligations for the continuous safety monitoring of medicines in The Gambia, ensuring that a product’s risk-benefit profile is actively managed throughout its lifecycle.
- Mandatory QPPV Requirement: The guideline legally requires MAHs to have a Qualified Person for Pharmacovigilance (QPPV) who is a registered healthcare professional residing in The Gambia and has formal PV training.
- Structured Submission of Safety Reports: MAHs are obligated to submit key regulatory documents on a defined schedule, including Periodic Safety Update Reports (PSURs/PBRERs) every six months for the first two years post-launch.
- Proactive Risk Management: The guideline mandates a proactive approach to safety through the submission of a Risk Management Plan (RMP) with new marketing applications, which must outline how potential risks will be monitored and minimized.
- Framework for Post-Authorisation Studies: It provides clear conditions and objectives for conducting Post-Authorisation Safety Studies (PASS) and Post-Authorisation Efficacy Studies (PAES), which can be imposed by the Agency to address safety or efficacy uncertainties.
- Enhanced Monitoring for Emergencies: A dedicated section outlines heightened pharmacovigilance measures for public health emergencies, requiring expedited reporting (within 24 hours) for any ADR related to a medicine under Emergency Use Authorisation (EUA).
