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Kenya
Guidelines on the Safety and Vigilance of Medical Products and Health Technologies
These guidelines, issued by the Pharmacy and Poisons Board (PPB) under the Ministry of Health, provide a comprehensive framework for monitoring the safety, quality, and efficacy of medical products and health technologies in Kenya.
Domesticated from the EAC Harmonized Compendium on Safety and Vigilance of Medical Products and Health Technologies (March 2019), the guidelines establish Kenya’s National Pharmacovigilance System, detailing the roles and responsibilities of patients, healthcare providers, regulatory authorities, pharmaceutical companies, and public health programs.
The resource underscores the importance of pharmacovigilance in improving patient safety, protecting public health, detecting adverse drug reactions (ADRs), monitoring adverse events (AEs), and ensuring accountability across the healthcare sector.
By strengthening reporting systems, inspections, training, and communication, the guidelines contribute to building a ro
Use Cases
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National Pharmacovigilance System – Framework for safety monitoring and post-market surveillance.
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Roles & Responsibilities – Guidance for patients, healthcare providers, pharmaceutical industry, regulators, and academia.
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Adverse Drug Reaction (ADR) Reporting – Clear processes for reporting, investigation, and feedback.
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Healthcare Obligations – Management of serious adverse events, AEFI, haemovigilance, and herbal/traditional medicine monitoring.
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Industry Compliance – Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Pharmacovigilance System Master File (PSMF), and post-authorization safety studies.
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Inspections & Audits – Processes for self-audits, regulatory inspections, sanctions, and follow-up.
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Training & Capacity Building – Promoting awareness and strengthening stakeholder skills.
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Safety Communication – Principles, target audiences, channels, and publication of safety notices.
Key takeaways you'll learn
