Quote from VigiServe Admin on November 27, 2020, 2:30 PM

The pharmacovigilance (PV) system in Afghanistan is still developing and relatively basic compared to more mature systems (e.g., in neighboring countries or ICH-aligned regions like Algeria). It operates under the oversight of the National Medicine and Health Products Regulatory Authority (NMHRA), previously referred to as part of the Ministry of Public Health (MoPH) or General Directorate of Pharmaceutical Affairs (GDPA), now often linked to the Afghanistan Food and Drugs Authority (AFDA) website (afda.gov.af or nmhra.gov.af). Afghanistan joined the WHO Programme for International Drug Monitoring (PIDM) in 2016, making it a full member of the global PV network, with reports potentially contributed to VigiBase via the national center.

Key aspects are derived from official sources (AFDA/NMHRA guidelines) and WHO support:

Legal Framework and Governance The NMHRA (under MoPH/AFDA) is the primary authority responsible for regulating medicines, including pre- and post-marketing vigilance, quality, safety, and efficacy. It handles market surveillance, adverse event monitoring, and recommendations on product safety. A National Pharmacovigilance Committee supports case review and analysis (e.g., in hospitals). WHO has provided technical assistance, including training on PV and GMP, and supported expansion to vaccination centers. The system emphasizes detection, assessment, and prevention of adverse reactions to ensure safe and rational medicine use. There is no dedicated national Good Pharmacovigilance Practices (GVP) guide specific to Afghanistan; instead, the AFDA/NMHRA references or adopts WHO Guidelines for Setting Up and Running a Pharmacovigilance Centre (available for download on their site).

Organization and Personnel Market Authorization Holders (MAHs), importers, or local representatives are expected to monitor product safety post-marketing. There is no explicit requirement for a local Qualified Person for Pharmacovigilance (QPPV) residing in Afghanistan (unlike stricter systems in some MENA countries), but a local authorized representative is often required for registration and market activities. Companies should designate responsible personnel for safety monitoring and reporting.

PV System Master File (PSMF) No specific requirement for a formal PSMF or its registration/location in Afghanistan is documented in available guidelines. PV activities are expected to be described in registration dossiers or company procedures, aligned with basic WHO principles.

Individual Case Safety Reports (ICSRs) Adverse drug reactions (ADRs) are collected via the national PV surveillance section (under post-market services at AFDA/NMHRA). Healthcare professionals, patients, and companies report suspected adverse reactions, quality issues, or lack of efficacy. Reports feed into analysis and recommendations to the authority. Specific expedited timelines (e.g., 15 days for serious) are not explicitly detailed in public guidelines; reporting follows general WHO-aligned practices for signal detection and risk management. Historical data indicate very low reporting volumes (often near zero ADRs per year in assessments up to recent years), reflecting under-development and challenges in implementation.

Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR) No mandatory periodic submission frequency (e.g., 6-monthly, annual) is specified in available Afghan guidelines. Safety data may be requested during registration renewals, inspections, or emerging concerns, but routine PSUR/PBRER obligations are not as structured as in ICH regions.

Risk Management Plans (RMP) Not a standard requirement for all products. Risk management and signal detection are part of ongoing market surveillance, with focus on identifying new risks proactively.

Signal Management and Emerging Safety Issues The PV section conducts regular surveillance, data collection on safety/quality/effectiveness, scientific analysis, and recommendations to NMHRA. Validated signals or major issues (e.g., foreign regulatory actions) should be notified promptly, though no fixed timelines (e.g., 5-45 days) are publicly detailed.

Additional Monitoring No specific black triangle scheme or additional monitoring symbols are mentioned for new substances or biologics. Emphasis is on general post-marketing vigilance, including recalls of harmful products and safe disposal coordination.

Overall Assessment Afghanistan's PV framework is functional but limited in maturity, with low ADR reporting rates, resource constraints, security/geographical challenges, and heavy reliance on WHO technical support. It focuses on basic market surveillance rather than detailed MAH obligations like those in EU/ICH or even some MENA countries adopting Arab GVP. For precise, product-specific requirements, consult the NMHRA/AFDA directly (via afda.gov.af or nmhra.gov.af), as guidelines may evolve. The WHO Guidelines for PV Centres remain the key referenced document. If operating in Afghanistan, align with WHO minimum PV system requirements and maintain robust internal monitoring to support national efforts.

What to report:

In order to improve patient safety, all health providers should report any suspected adverse reaction due to any medications (drugs or biologicals) vaccines, and herbal remedies; if the reaction is weak, mild or severe.

Address:

Pharmacovigilance Centre -Medicine Safety Committee/General, Directorate of Pharmaceutical Affairs (GDPA), Shah-edoshamshera, Besides Afghanistan Technical Vocational Institute, Opp. Ministry of Education printing press,

Kabul, Afghanistan.

Tel: 0202104659

E-Mail: pvcenterafg@gmail.com