Quote from VigiServe Admin on December 8, 2020, 1:35 PM

The pharmacovigilance (PV) landscape in **Arab countries** (primarily the 22 member states of the League of Arab States, spanning the MENA region) is diverse, ranging from basic WHO-aligned systems to more advanced, ICH/EU-harmonized frameworks in Gulf Cooperation Council (GCC) and some North African countries. There is no single, universally binding Arab-wide PV regulation, but the **League of Arab States** issued the **Guideline on Good Pharmacovigilance Practices (GVP) for Arab Countries** (Version 3, December 2015), which serves as a recommended harmonization model based heavily on EU GVP modules. Many countries adopt or reference it, with local adaptations and ongoing updates (e.g., Kuwait's KuGVP Version 6 in January 2026, Saudi SFDA GVP Version 4 in 2025).

**Common Features Across Arab Countries**
Most countries are WHO PIDM members and contribute to VigiBase via VigiFlow. Key shared elements include:
- Mandatory reporting of suspected **serious adverse drug reactions (ADRs)** (typically within **15 calendar days** of awareness/receipt).
- **Non-serious ADRs** reported within **90 calendar days** or in periodic aggregates.
- Emphasis on post-marketing surveillance, signal detection, risk assessment, and regulatory actions (alerts, label changes, recalls).
- **Risk Management Plans (RMP)** often required for new/high-risk products, biologics, or biosimilars (EU-style format with national annex for local adaptations).
- **Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)** submitted in ICH E2C(R2) format (frequency varies: often 6-monthly initially, then annually, or on request/renewal).
- No universal black triangle/additional monitoring scheme, but active surveillance common for vaccines/biologics.

**Organization and Personnel**
- Most require a **local Qualified Person for Pharmacovigilance (QPPV)** or equivalent (resident in-country, qualified physician/pharmacist; primary authority contact).
- **PV System Master File (PSMF)** increasingly required (e.g., in GCC countries and Egypt), describing the PV system and available for inspections.
- Local agents/representatives often appoint a **Local Safety Responsible Person (LSR)**.

**Clinical Trials-Related Safety Requirements**
- Clinical trials require national ethics/regulatory approval (often aligned with ICH GCP).
- Sponsors must report **Suspected Unexpected Serious Adverse Reactions (SUSARs)** expeditiously: typically **7 calendar days** for fatal/life-threatening and **15 calendar days** for other serious unexpected (ICH E2A-aligned).
- **Development Safety Update Reports (DSURs)** usually annual (ICH E2F format).
- Reports submitted directly to national authorities (no unified Arab electronic system like EudraVigilance).

**Country-Specific Variations (Selected Examples)**
- **GCC Countries** (Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, Oman): Most advanced; heavily EU/ICH-harmonized via GCC centralized registration and local GVP (e.g., Saudi SFDA GVP v4 2025, Kuwait KuGVP v6 2026, UAE MOHAP GVP). Strict local QPPV/PSMF/RMP mandates, risk-based inspections, and expedited serious reporting (15/90 days). Kuwait's 2026 KuGVP includes detailed PSMF/PSSMF, RMP structure, and audit/inspection rules.
- **Egypt**: Egyptian Drug Authority (EDA) GVP (updated 2025) mandates local QPPV, PSMF, 15/90-day reporting, routine PSURs, and RMPs for high-risk products.
- **Morocco**: AMMPS/CAPM follows Arab GVP + national rules; local QPPV common, 15/90-day timelines, RMP for high-risk.
- **Jordan**: JFDA aligns with Arab GVP; local QPPV, PSMF, and structured reporting.
- **Other countries** (e.g., Iraq, Algeria, Tunisia, Lebanon): Often basic WHO-aligned systems with less stringent MAH obligations (no routine PSUR/RMP mandates, prompt/15-day serious reporting).

**Overall Assessment**
Arab countries show progressive harmonization (driven by League of Arab States GVP and GCC efforts), with 2025–2026 seeing maturity gains (e.g., stricter QPPV/PSMF/RMP, inspections, and electronic tools). GCC and select North African nations approach EU/ICH levels, while others remain basic (spontaneous reporting focus, limited MAH burdens). Clinical trial safety follows global expedited SUSAR timelines (7/15 days) and annual DSURs.

For country-specific precision (e.g., exact timelines/forms in a particular nation), consult national authorities (e.g., SFDA Saudi Arabia, MOHAP UAE, EDA Egypt, AMMPS Morocco, or MoH Kuwait via moh.gov.kw) or the League of Arab States resources, as local implementations vary and evolve rapidly (e.g., Kuwait's KuGVP 2026 updates). Companies operating regionally often use local QPPV and align with Arab GVP for consistency.