Quote from VigiServe Admin on January 31, 2026, 7:33 AM

The pharmacovigilance (PV) system in **Jordan** is well-developed and largely aligned with **Arab Good Pharmacovigilance Practices (GVP)** guidelines (Version 3, 2015, with national adaptations), **WHO** standards, and elements of **EU GVP** (due to JFDA's role in Arab GVP development and regional harmonization). Jordan has been a full WHO PIDM member since 2001, contributing to VigiBase. The **Jordan Food and Drug Administration (JFDA)** oversees PV through the **Rational Drug Use and Pharmacovigilance Department** (national PV center), which handles ADR collection, signal detection, causality assessment (e.g., using WHO-UMC method), risk evaluation, alerts, recalls, and inspections. The yellow card system is used for spontaneous reporting.

**Legal Framework and Governance**
- Governed by **Law No. 80/2001** on Medicines and Pharmacy (amended) and JFDA regulations/directives (e.g., "The Pharmacovigilance Directives").
- JFDA's Rational Drug Use and Pharmacovigilance Department coordinates nationally, with regional/hospital support.
- Recent developments (2025–2026): JFDA released updated ADR reporting user guides for public consultation (Nov–Dec 2025) and joined PIC/S (Jan 2026), strengthening quality/PV inspections.

**Organization and Personnel**
- Marketing Authorization Holders (MAHs)/companies must establish/maintain a PV system compliant with JFDA/Arab GVP requirements.
- **Qualified Person for Pharmacovigilance (QPPV)** or local equivalent: Required in practice (local resident physician/pharmacist with PV experience; primary JFDA contact).
- **Pharmacovigilance System Master File (PSMF)**: Required (describes PV system; available for JFDA inspections; no mandatory registration/location detailed publicly).

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- HCPs (primary reporters via yellow card), MAHs, and others report suspected ADRs (serious/unexpected prioritized), medication errors, or quality issues to JFDA (via forms, electronic channels, or regional centers).
- Timelines (aligned with Arab GVP/ICH):
- **Serious ICSRs** (domestic/unexpected): Expedited within **15 calendar days** of receipt/awareness.
- **Non-serious ICSRs**: Within **90 calendar days** or periodic aggregates.
- Reports use standard formats; causality assessed; feed into national database and VigiBase.

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

**Risk Management Plans (RMP)**
- Required for new/high-risk products, biologics, or specific concerns (per Arab GVP Module V).
- Submit RMP with pharmacovigilance/risk minimization plans; updates for changes/new risks (national annex if EU/global RMP exists).

**Signal Management and Emerging Safety Issues**
- JFDA conducts ongoing surveillance/signal detection.
- MAHs monitor data and notify significant/emerging issues promptly (no fixed 5–45 day timelines publicly detailed beyond general promptness per Arab GVP).

**Clinical Trials-Related Safety Requirements**
Clinical trials require JFDA approval (via Clinical Trial Application) and ethics committee review (aligned with ICH GCP principles).
- Sponsors monitor safety and report serious adverse events/SAEs.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**: Expedited reporting (aligned with ICH E2A/Arab GVP; typically **7–15 days** for serious unexpected, faster for fatal/life-threatening; trial-specific in approvals).
- No dedicated national electronic system (e.g., no EudraVigilance); reports submitted directly to JFDA (forms/email).
- Periodic safety reporting: **Development Safety Update Reports (DSURs)** or annual updates may be required/requested (ICH E2F or WHO formats), especially for ongoing/multi-country trials.
- Sponsor responsibility for monitoring, causality assessment, and communication to JFDA/ethics committees.

**Additional Monitoring / Other Aspects**
- No black triangle/additional monitoring scheme.
- Emphasis on spontaneous reporting (yellow card), hospital committees, quality surveillance, counterfeit detection, and public health programs.
- Inspections/audits by JFDA possible (enhanced post-PIC/S accession Jan 2026); reporting volumes moderate, with improvements via guidelines/training.

Jordan's PV framework is robust and Arab GVP-aligned (strong on serious reporting, local QPPV, RMP for high-risk), more mature than many regional peers but less prescriptive than full EU/ICH systems (e.g., no universal routine PSUR cycles detailed publicly). It prioritizes national coordination and compliance monitoring.

For precise, product- or trial-specific details (e.g., latest ADR guides from Nov–Dec 2025 consultation, forms, or exact timelines), consult the **Jordan Food and Drug Administration (JFDA)** directly via jfda.jo (Rational Drug Use and Pharmacovigilance section, downloads, or contacts), as requirements evolve with updates and PIC/S membership. Companies often use local QPPV/consultants for compliance in Jordan.