The pharmacovigilance (PV) system in Pakistan is well-structured and aligned with international standards (e.g., WHO guidelines), governed by the Drug Regulatory Authority of Pakistan (DRAP) under the DRAP Act, 2012. Key legal basis includes the Pharmacovigilance Rules, 2022 (S.R.O 540 (I)/2022, effective April 22, 2022), which mandate PV obligations for stakeholders. The system focuses on post-marketing surveillance of therapeutic goods (medicines, biologics, vaccines, etc.) to monitor safety, detect signals, and manage risks.
Legal Framework and Governance
- DRAP (under Division of Pharmacy Services) oversees national PV.
- National Pharmacovigilance Centre (NPC): Established in Islamabad (Prime Minister’s National Health Complex, Park Road), collects reports, detects/manages signals, assesses risks, recommends actions, issues alerts/newsletters, and coordinates nationally/globally. Contact: npc@dra.gov.pk, +92-51-9255981.
- Pharmacovigilance Risk Assessment Expert Committee (PRAEC): Advisory body (notified 2022) for signal detection, causality assessment, risk minimization, communication, and evaluation of periodic reports/RMPs.
- Provincial Pharmacovigilance Centres (PPCs), Public Health Programmes (PHPs), hospitals, and registration holders contribute. Pakistan is a full WHO PIDM member (since 2018), contributing to VigiBase via tools like VigiFlow/Med Vigilance e-reporting.
Organization and Personnel Registration Holders (RHs, equivalent to MAHs) must establish and maintain a PV system per Guidelines on Good Pharmacovigilance Practices for Registration Holders (updated versions available on dra.gov.pk).
- Appoint a Qualified Person for Pharmacovigilance (QPPV) or equivalent responsible person.
- Maintain a Pharmacovigilance System Master File (PSMF) describing the system, procedures, and contacts (available for inspection). RHs monitor global/domestic safety data and serve as key reporters to NPC.
Individual Case Safety Reports (ICSRs)
- Suspected ADRs/AEs/AEFIs reported spontaneously via:
- Yellow Form (for HCPs).
- Med Vigilance e-Reporting System (WHO-based, open to patients, HCPs, RHs).
- RHs collect/record/analyze reports and submit to NPC.
- Serious ICSRs: Expedited reporting timelines apply (aligned with ICH/WHO; typically 15 days for serious, though exact in GVP guidelines for RHs).
- Non-serious: Periodic or as required.
- Foreign cases: Included in periodic reports if relevant.
Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)
- RHs submit periodic reports to NPC/DRAP in ICH E2C(R2) format.
- Frequency: Typically every 6 months initially, then annually or as specified (standard for new products; details in GVP for RHs).
- Evaluated by NPC, with PRAEC advice.
Risk Management Plans (RMP)
- Required for certain products (e.g., new substances, high-risk, biologics).
- RHs submit RMPs to NPC for assessment; PRAEC advises on risk minimization measures.
- Updates required for significant changes or new concerns.
Signal Management and Emerging Safety Issues
- NPC handles signal detection/validation (using disproportionality analysis, etc.), with PRAEC advisory input.
- Validated signals/escalating issues: Prompt notification and action (timelines per rules/guidelines, e.g., rapid for major risks).
- RHs continuously monitor and notify emerging safety concerns.
Additional Monitoring / Other Aspects
- No explicit black triangle scheme mentioned, but active surveillance possible for new biologics/vaccines, orphan drugs, emergency-use products, or as registration condition.
- Post-Authorization Safety Studies (PASS): Voluntary or imposed (e.g., by Registration Board on PRAEC/NPC recommendation).
- Inspections: DRAP conducts GVP inspections of RH PV systems.
- Reporting encouraged from HCPs, patients, PHPs, hospitals; low historical volumes improving with training/e-tools.
Pakistan's PV framework has matured significantly since 2017–2022 reforms, with ongoing WHO collaboration (e.g., training in 2025). It is more developed than Afghanistan's but less stringent than ICH-full systems. For precise, product-specific details (e.g., exact timelines, forms), refer directly to DRAP website (dra.gov.pk) publications:
- Guidelines on National Pharmacovigilance System (latest edition ~2024–2025).
- Good Pharmacovigilance Practices for Registration Holders. Contact NPC for submissions or clarifications, as requirements evolve.
Contact Details
Pakistan National Pharmacovigilance Centre (PNPC),
Drug Regulatory Authority of Pakistan, Telecom Foundation (TF) Complex, 7-Mauve Area, G-9/4, ISLAMABAD, Pakistan.
TEL: +92-519107413, +92-51926218
E-Mail Address: npc@dra.gov.pk,