Quote from VigiServe Admin on November 28, 2020, 5:43 AM

June 2023 - Pharmacovigilance Requirements in Zambia

The pharmacovigilance (PV) system in Zambia is functional and aligned with WHO minimum requirements for national PV systems, with ongoing development supported by WHO and regional partners. Zambia is a full member of the WHO Programme for International Drug Monitoring (PIDM) and contributes Individual Case Safety Reports (ICSRs) to VigiBase via VigiFlow. The system emphasizes spontaneous reporting, post-marketing surveillance, and safety monitoring, particularly for antiretrovirals (ARVs), vaccines, and new medicines.

Legal Framework and Governance

• Primary authority: Zambia Medicines Regulatory Authority (ZAMRA), established under the Medicines and Allied Substances Act, 2013.
• ZAMRA oversees all PV activities through the National Pharmacovigilance Unit (NPVU) (also called National Pharmacovigilance Centre), which manages day-to-day operations, ADR collection, signal detection, risk assessment, and communication.
• Key documents:
  • Zambia Pharmacovigilance Reference Manual (March 2020)
  • Handbook for Reporting Adverse Drug Reactions, Medication Errors and Product Quality Problems (March 2020, updated June 2023)
  • Guidelines for Detecting and Reporting Adverse Drug or Vaccine Reactions and Events
• These documents follow WHO principles and provide practical guidance for healthcare workers, marketing authorization holders (MAHs), and the public.
• Recent developments (2025–2026): ZAMRA is actively developing more detailed PV guidelines, including requirements for a Local Responsible Person (or Local Qualified Person for Pharmacovigilance – LQPPV) for foreign-based MAHs.

Organization and Personnel

• Marketing Authorization Holders (MAHs) are required to establish and maintain a pharmacovigilance system to monitor product safety post-marketing.
• Foreign-based MAHs must appoint a Local Responsible Person (LRP) resident in Zambia (requirement strengthened in recent notices).
• ZAMRA is developing specific guidelines defining the minimum qualifications for an LQPPV / LRP.
• No formal requirement for a Pharmacovigilance System Master File (PSMF) is currently mandated.

Individual Case Safety Reports (ICSRs) – Post-Marketing

• Healthcare professionals, patients, and MAHs report suspected adverse drug reactions (ADRs), medication errors, and product quality issues voluntarily.
• Reporting channels:
  • Paper-based ADR forms (available at district/provincial health offices, health facilities, or ZAMRA).
  • Online via ZAMRA’s Safety Watch portal or e-reporting tools.
  • Direct submission to NPVU/ZAMRA.
• Timelines: Not strictly codified with fixed calendar days in the main public manuals (e.g., no universal 15/90-day rule). Guidance emphasizes prompt reporting, especially for serious and unexpected ADRs. In practice, serious local cases are expected to be reported quickly (often within days to weeks), aligning with WHO expectations and regional SADC practices.
• Reports are analyzed for signals and used for regulatory action (e.g., alerts, label changes, recalls).

Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)

• No routine mandatory periodic submission frequency is explicitly detailed in current public guidelines.
• MAHs may be required to submit safety updates or periodic reports upon request, during registration renewal, or when significant safety concerns arise.

Risk Management Plans (RMP)

• Not a standard mandatory requirement for all products.
• Risk minimization measures are implemented reactively based on NPVU signal detection or specific concerns.

Signal Management and Emerging Safety Issues

• NPVU conducts ongoing surveillance and signal detection.
• MAHs must continuously monitor global and local safety data and notify ZAMRA of significant emerging safety issues promptly (no fixed timelines like 5–45 days are publicly specified).

Clinical Trials-Related Safety Requirements Clinical trials are regulated by ZAMRA under the Medicines and Allied Substances Act and specific clinical trial guidelines (updated versions available on zamra.co.zm).

• Sponsors must monitor safety throughout the trial and report safety concerns to ZAMRA.
• Suspected Unexpected Serious Adverse Reactions (SUSARs) and other serious adverse events must be reported expeditiously.
• No dedicated national electronic portal (e.g., no EudraVigilance/CTIS); reports are submitted directly to ZAMRA (often via email, forms, or safety watch channels).
• Timelines: Expedited reporting for serious unexpected events (typically aligned with international norms — 7–15 days, faster for fatal/life-threatening), though exact days are not rigidly codified in public documents beyond the general requirement to notify “any safety concerns that arise during the conduct of the study.”
• Periodic safety reporting (e.g., Development Safety Update Reports – DSURs) may be required or requested, following ICH E2F or WHO formats, especially for ongoing or multi-country trials.
• Emphasis on investigator/sponsor responsibility for monitoring, causality assessment, and communication to ZAMRA and ethics committees.

Additional Monitoring / Other Aspects

• No black triangle scheme or specific additional monitoring for new active substances/biologics.
• Focus on active PV for high-priority programs (e.g., ARVs, vaccines, TB medicines).
• Both paper and electronic reporting tools are used; healthcare worker training and engagement are ongoing priorities.
• Inspections and audits by ZAMRA are possible; ADR reporting volumes remain moderate but are improving with awareness campaigns.

Zambia’s PV framework is WHO-aligned and practical but relatively basic — it prioritizes spontaneous reporting, serious ADR detection, and regulatory action over highly structured MAH obligations (no mandatory PSMF, no routine PSUR frequency, evolving LQPPV requirements). It is more developed than many smaller African nations but less detailed than ICH-aligned or mature SADC systems.

For precise, product-specific, or trial-specific requirements (including current timelines, forms, or the status of LQPPV guidelines), consult ZAMRA directly via their website (zamra.co.zm), the National Pharmacovigilance Unit, or official contact channels, as PV regulations and guidance are actively evolving (notably in 2025–2026). Companies operating in Zambia typically align with WHO minimum standards and reference regional SADC practices.