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Sierra Leone
A GUIDE FOR SAFETY MONITORING OF MEDICINES IN SIERRA LEONE
This guide, developed by the Pharmacy Board of Sierra Leone (PBSL), ensures the safety monitoring of regulated medicinal products. It provides detailed guidance to Healthcare Professionals, Consumers, and Marketing Authorization Holders (MAHs) on establishing and maintaining a robust pharmacovigilance (PV) system. Key topics covered include the Pharmacovigilance System Master File (PSMF), Adverse Reaction reporting, Risk Management Plans (RMP), safety variations, and post-authorization studies (PASS/PAES). Its ultimate goal is to improve the safe and rational use of medicines, thereby enhancing patient care and public health.
Use Cases
- Marketing Authorisation Holders (MAHs) – System Establishment and Maintenance: They must establish and maintain a Pharmacovigilance (PV) system to fulfil specific PV tasks, monitor marketed medicinal products, and detect changes to their risk-benefit balance.
- Qualified Person for Pharmacovigilance (QPPV) – Adverse Reaction Information Management: They must establish and maintain a system ensuring that information about all suspected adverse drug reactions/events reported to the MAH’s personnel is collected, collated, and assessed for submission to the Board.
- Pharmacy Board of Sierra Leone (PBSL) – Regulatory Review and Action: The PBSL’s expert committee shall review safety information and make recommendations to the Board regarding actions to resolve issues related to post-approval product safety, quality, and efficacy.
- Sponsors (Innovator and Generic) – Submit Periodic Reports: Marketing Authorization Holders of both innovator and generic drugs are required to submit Periodic Benefit-Risk Evaluation Reports (PBRER) at the time of renewal of the drug’s registration.
- PBSL – Reliance on Other NRAs: The Board can rely (partly or fully) on pharmacovigilance decisions or scientific opinions, such as RMP/PBRER assessments, from well-resourced National Regulatory Authorities (NRAs), regional, and international bodies.
- MAHs – Risk Management Planning: They must refer to GVP Module V and ICH E2E to submit a Risk Management Plan (RMP), ensuring the RMP should be a largely stand-alone document and includes a Sierra Leone Specific Annex.
Key takeaways you'll learn
The resource’s purpose is to establish a unified and comprehensive regulatory framework for safety monitoring, ensuring all medicinal products in Sierra Leone maintain an acceptable benefit-risk profile throughout their lifecycle.
- Comprehensive PV Scope: The guide covers all major aspects of modern pharmacovigilance, including the PV System Master File (PSMF), Risk Management Plans (RMP), Periodic Reporting (PBRER/PSUR), and PV Inspections.
- International Harmonization: The PBSL facilitates compliance by accepting a single harmonized International Birth Date (IBD) and Data Lock Point (DLP) for PBRER/PSUR submissions to reduce the burden on MAHs.
- Reliance Pathway for Efficiency: PBSL leverages reliance on pharmacovigilance decisions, assessment reports on PBRER/PSUR, and scientific opinions from well-resourced NRAs and international bodies to accelerate evaluations without compromising safety.
- Mandatory QPPV Requirement: The guide explicitly defines the requirement for a Qualified Person Responsible for Pharmacovigilance (QPPV) and their role in ensuring the MAH’s PV system is maintained.
- Proactive Risk Management: MAHs must submit an RMP, which may require a Sierra Leone Specific Annex, ensuring that the Board can monitor and manage risks relevant to the local population.
