Pharmacovigilance Services in Kenya

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Kenya, explore DDReg’s pharmacovigilance services in Kenya to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with the National Pharmacovigilance Centre (NPC) guidelines, the right PV partner shapes everything: signal detection , risk management planning, safety reporting, and successful market authorization.

Expert Pharmacovigilance Services for the Kenya Market

The National Pharmacovigilance Centre (NPC), under the Pharmacy and Poisons Board and the Ministry of Health, is the national authority responsible for post-market safety surveillance of pharmaceuticals in Kenya. Clinical trials often do not capture all adverse drug reactions (ADRs), especially rare ones, which may emerge only after the product is on the market. The Pharmacovigilance Risk Assessment and Advisory Committee (PRAAC) assists in assessing causal relationships between ADRs and medicinal products. In Kenya, the general public, healthcare providers, National Medicines Regulatory Authorities (NMRAs), public health programs (PHPs), and marketing authorization holders (MAHs) are all responsible for reporting ADRs through standardized forms. A QPPV ensures centralized oversight and acts as the single point of contact for MAHs regarding pharmacovigilance.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing through E2B(R3) compliant databases integrated with WHO Drug Dictionary and MedDRA
  • Quality check and medical reviews
  • Submission of cases according to NPC timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs and REMS with submission support
  • Preparing customized procedures to classify safety risks and deliver tailored risk management plans
  • Assessment of potential risks and missing information, with reports recommending mitigation methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), academic materials, observational studies, and targeted follow-up questionnaires
  • Effectively conveying risks through labelling documents such as Summary of Product Characteristics (SmPC) and patient information leaflets (PIL)
• + Aggregate Reports
  • Periodic Safety Update Reports (PSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new safety signals and/or changes in risks from ICSRs, literature, PV aggregate reports, and regulatory agency website monitoring
  • Recommendations from signal assessments including risk minimization approaches
  • Preparation of Signal Management Tracker and Annual Signal Reports
• + Local Pharmacovigilance Services in Kenya
  • Authoring & review of PSMF, PV SOPs, SDEAs
  • Retainer services for QPPV and deputy
  • Monthly reconciliation and compliance reporting
  • Medical review of signal detection and quarterly Signal Surveillance Meetings
• + PV Quality Management & Compliance
  • PV audit and compliance reviews against applicable PV guidelines, regulations, SDEAs, SOPs, and work instructions
  • Design of audit plans and mock audits to prepare organizations for PV inspections
  • Regular gap assessments of PV staff
  • Organizational training on safety audits and inspections