Quote from VigiServe Admin on November 27, 2020, 1:06 PM

The pharmacovigilance (PV) system in Nepal is functional and aligned with WHO minimum standards, with ongoing development supported by international partners (e.g., USAID MTaPS program). Nepal joined the WHO Programme for International Drug Monitoring (PIDM) in 2006 as a full member, contributing Individual Case Safety Reports (ICSRs) to VigiBase via VigiFlow. The system emphasizes post-marketing surveillance, adverse drug reaction (ADR) collection, and quality monitoring, though reporting volumes remain low due to awareness, infrastructure, and resource constraints.

Legal Framework and Governance

• Primary authority: Department of Drug Administration (DDA) under the Ministry of Health and Population, as per the Drugs Act 1978 (and regulations). DDA serves as the national PV center.
• Key functions: ADR monitoring, post-marketing surveillance, signal detection, risk management, and product recalls.
• Network: 20+ Regional Pharmacovigilance Centers (RPCs) (e.g., in hospitals/pharmacies) collect ADRs and forward to DDA (national center) via VigiFlow for global submission.
• Recent updates: Revised ADR reporting form (May 2025), guidelines for risk-based post-marketing quality surveillance (RB-PMS, 2080 BS ~2023/2024), and efforts to strengthen PV through training and tools. No comprehensive standalone national GVP guide exists publicly; aligns with WHO principles and basic requirements.

Organization and Personnel

• Marketing Authorization Holders (MAHs)/importers/manufacturers must implement a robust PV system for ongoing safety monitoring post-registration (legal requirement).
• No explicit mandatory local Qualified Person for Pharmacovigilance (QPPV) or resident PV contact is detailed in public sources (unlike stricter systems). Companies set up internal PV procedures, often with support from consultants for compliance.
• Reporting primarily from healthcare professionals (HCPs), hospitals, RPCs, and manufacturers; patient reporting encouraged but limited.

PV System Master File (PSMF) No formal requirement for a PSMF or registration/location in Nepal.

Individual Case Safety Reports (ICSRs) – Post-Marketing

• Suspected ADRs reported voluntarily/spontaneously via revised ADR form (available on dda.gov.np) or VigiFlow to RPCs/DDA.
• No strict codified expedited timelines (e.g., 15/90 days) publicly specified beyond general WHO expectations: prompt reporting encouraged for serious/unexpected events to enable signal detection. Manufacturers submit received ADRs.
• Reports use standard formats; forwarded to Uppsala Monitoring Centre (UMC) via VigiFlow.

Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)

• Periodic Safety Update Reports (PSURs) are mandatory for registered products; regular submission required per DDA timelines and format (often aligned with basic WHO/ICH-like expectations).
• Frequency not rigidly detailed publicly (e.g., no standard 6-monthly/annual cycle specified); submitted during renewals, variations, or on request.

Risk Management Plans (RMP) Not a standard mandatory requirement for all products; risk assessment handled through national surveillance, RB-PMS, and reactive measures (e.g., recalls).

Signal Management and Emerging Safety Issues

• DDA/RPCs conduct ongoing monitoring and signal detection.
• Significant issues (e.g., new risks, foreign actions) should be notified promptly to DDA; no fixed timelines (e.g., 5-45 days) detailed publicly.

Clinical Trials-Related Safety Requirements Clinical trials are regulated by DDA under the Drugs Act 1978, with recent strengthening (2022–2024) via MTaPS support: developed clinical trial regulations, guidelines, SOPs, application forms, adverse event reporting tools, and inspection guidelines.

• Sponsors must monitor safety, assess causality, and report serious adverse events, including Suspected Unexpected Serious Adverse Reactions (SUSARs) or equivalent.
• No dedicated national electronic system (e.g., no EudraVigilance/CTIS); reports submitted directly to DDA (via forms/email).
• Timelines align with international/WHO norms: expedited for serious unexpected events (typically 7-15 days, faster for fatal/life-threatening), though not explicitly codified beyond general PV/ADR rules.
• Periodic/Development Safety Update Reports (DSURs) may be required or requested, following ICH E2F/WHO formats, especially for ongoing/multi-country trials.
• DDA conducts inspections; emphasis on participant protection, scientific integrity, and sponsor responsibility for monitoring/communication to authorities/ethics committees.

Additional Monitoring / Other Aspects

• No black triangle/additional monitoring scheme.
• Focus on quality surveillance (RB-PMS), GMP compliance, counterfeit detection, and public health programs.
• Inspections by DDA; low ADR reporting persists (under-reporting common), but improvements via revised forms, training, and regional centers.

Nepal's PV framework is basic to moderate in maturity—no stringent MAH obligations like QPPV/PSMF/RMP mandates or highly detailed timelines—but evolving with WHO alignment and recent regulatory enhancements. It prioritizes spontaneous reporting, quality assurance, and capacity building. For precise, product- or trial-specific requirements (e.g., current PSUR formats, clinical trial submissions), consult DDA directly (dda.gov.np; pharmacovigilance section or info@dda.gov.np), as guidelines continue to develop. Companies often align with WHO minimums or reference regional/international standards for operations in Nepal.