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Rwanda 🇷🇼
Guidelines on Safety and Vigilance of Medical Products and Health Technologies (PSM/GDL/011)
These guidelines, issued by the Rwanda Food and Drugs Authority (Rwanda FDA), provide a comprehensive framework for pharmacovigilance and post-market safety monitoring of medical products and health technologies in Rwanda.
Developed under the East African Community (EAC) Medicine Regulatory Harmonization initiative, the document aligns Rwanda’s system with regional and international best practices.
Use Cases
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Pharmacovigilance systems → principles of good practices, quality systems, training, and documentation.
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Roles & responsibilities → defined for Rwanda FDA, advisory committees, public health programs, healthcare facilities, Marketing Authorisation Holders (MAHs), Qualified Persons for Pharmacovigilance (QPPVs), academia, and patients.
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Adverse event reporting → detailed procedures for spontaneous and active surveillance, covering vaccines (AEFIs), medical devices, herbal medicines, clinical trials, and poor-quality products.
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Risk management systems → format and monitoring of Risk Management Plans (RMPs).
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Post-Authorisation Safety Studies (PASS) and Periodic Safety Update Reports (PSURs/PBRERs/DSURs).
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Signal detection & management → processes for evaluation, prioritization, and communication.
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Pharmacovigilance System Master File (PSMF) requirements.
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Inspections & audits of pharmacovigilance systems.
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Safety communication & regulatory actions → procedures for alerts, recalls, withdrawals, and appeals.
Key takeaways you'll learn
