Quote from VigiServe Admin on November 28, 2020, 9:19 AM

 

ONLINE REPORTING

The pharmacovigilance (PV) system in **Kenya** is well-structured and aligned with international standards (e.g., WHO, ICH principles, and EAC harmonized guidelines), managed by the **Pharmacy and Poisons Board (PPB)** under the **Pharmacy and Poisons Act (Cap 244)** and key subordinate legislation. The primary reference is the **Pharmacy and Poisons (Pharmacovigilance and Post Marketing Surveillance) Rules, 2022** (Legal Notice No. 96/2022), which mandates PV obligations for Marketing Authorization Holders (MAHs), parallel importers, and local technical representatives. PPB operates the **National Pharmacovigilance Centre** (via the Pharmacovigilance and Post-Market Surveillance Department), which collects ADRs/AEFIs, detects signals, assesses risks, issues alerts, conducts inspections, and contributes to VigiBase via **VigiFlow** and the **Pharmacovigilance Electronic Reporting System (PvERS)**.

Recent developments (2025–2026) include enforcement of **Qualified Person for Pharmacovigilance (QPPV)** nominations (final reminders in October 2025, full compliance expected from 2026), risk-based GVP inspections, and active surveillance plans (2022–2025 framework).

**Legal Framework and Governance**
- PPB oversees the national PV system, including the PvERS for electronic reporting.
- Harmonized with **EAC Compendium on Safety and Vigilance of Medical Products and Health Technologies** (adopted regionally).
- Focus: Spontaneous reporting, active surveillance (e.g., for antiretrovirals, vaccines, high-risk products), hospital PV committees, and post-marketing quality/safety monitoring.

**Organization and Personnel**
- MAHs must establish and maintain a PV system compliant with PPB rules and guidelines (including PSMF establishment per 2022/2025 guidelines).
- Appoint a **Qualified Person for Pharmacovigilance (QPPV)**: Mandatory; must be a resident in Kenya with a Bachelor's Degree in Pharmacy (or equivalent), relevant experience, and PPB designation/letter (nomination required; final compliance push in 2025–2026). The QPPV acts as the main liaison with PPB, oversees the PV system, and ensures compliance.
- **PV System Master File (PSMF)**: Required (MAH establishes/maintains; QPPV maintains it); available for PPB inspections (no mandatory registration/location, but accessibility enforced).

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- MAHs, HCPs, patients, and others report suspected ADRs/AEFIs, medication errors, poor-quality products, or transfusion reactions via PvERS (electronic preferred), forms, or channels.
- Timelines (aligned with ICH/WHO and PPB rules):
- **Serious ICSRs** (unexpected or with increased frequency/severity): Expedited within **15 calendar days** of receipt.
- **Non-serious ICSRs**: Within **90 calendar days** or periodic aggregates.
- Foreign ICSRs: Included in periodic reports if relevant to benefit-risk.

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- MAHs submit periodic safety reports (ICH E2C(R2)-like format).
- Frequency: Not rigidly standardized for all (no mandatory 6-monthly/annual cycle universally); typically required during renewals, variations, or on request/safety concerns (evaluated by PPB).

**Risk Management Plans (RMP)**
- Not mandatory for all products; required or requested for high-risk/new substances, biologics, or specific concerns (per EAC harmonized guidelines and PPB risk assessment).
- Submit RMP with pharmacovigilance plan and risk minimization measures; updates for changes/new risks.

**Signal Management and Emerging Safety Issues**
- MAHs continuously monitor data; notify PPB of validated signals or emerging concerns promptly.
- PPB leads national signal detection (using VigiLyze/tools); may trigger alerts, label updates, or recalls.

**Clinical Trials-Related Safety Requirements**
Clinical trials require PPB approval (via Clinical Trial Application, per **Guidelines for the Conduct of Clinical Trials in Kenya** (2nd Revision ~2020, with updates) and CTRules). Trials follow ICH GCP principles.
- Sponsors monitor safety and report to PPB.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**: Expedited reporting (aligned with ICH E2A; typically **7–15 days** for serious unexpected, faster for fatal/life-threatening; initial reports as soon as possible).
- No direct EudraVigilance access; reports via PPB channels (electronic/forms).
- **Development Safety Update Reports (DSURs)**: Annual/periodic required (ICH E2F format), especially for ongoing trials.
- Sponsor responsibility for monitoring, causality assessment, DSMB (if applicable), insurance for trial-related injury, and submission to PPB/ethics committees.
- Records archived in Kenya; PPB may withdraw authorization if safety compromised.

**Additional Monitoring / Other Aspects**
- No black triangle scheme, but active surveillance for priority products (e.g., vaccines, antiretrovirals).
- Emphasis on PvERS electronic reporting, HCP/patient submissions, hospital committees, and inspections (risk-based GVP).
- Reporting volumes improving with training and tools; under-reporting addressed via awareness.

Kenya's PV framework is robust and EAC/WHO-aligned, with growing enforcement (e.g., mandatory local QPPV from 2026, GVP inspections) — more developed than many African peers but less prescriptive than full ICH/EU systems (e.g., no universal routine PSUR frequency). It balances MAH obligations with national surveillance.

For precise, product- or trial-specific details (e.g., latest QPPV guidelines March 2025, PvERS forms, or EAC Compendium), consult **PPB** directly via pharmacyboardkenya.org (Pharmacovigilance section, downloads for guidelines/rules, or contacts), as requirements evolve (e.g., 2025–2026 compliance pushes). Companies often appoint local QPPV/consultants for compliance in Kenya.