Quote from VigiServe Admin on January 18, 2024, 5:37 AM

Guideline

The pharmacovigilance (PV) system in **Somalia** is emerging and basic, aligned with **WHO** minimum standards for functional national PV systems. Somalia joined the WHO Programme for International Drug Monitoring (PIDM) and began contributing to VigiBase around 2019–2020, with significant progress in 2023–2025 through WHO, Africa CDC, and partner support (e.g., nationwide training, digital tools, standardized forms, and increased ADR reporting targets by end-2025). The system focuses on spontaneous ADR/AEFI reporting, signal detection, and safety monitoring, particularly in public health programs (e.g., vaccines, antimalarials, antiretrovirals).

**Legal Framework and Governance**
- Primary authority: **National Medicines Regulatory Authority (NMRA)** (interim NMRA under Federal Ministry of Health [MoH]), established to oversee medicines regulation and PV.
- Key document: **Somalia Pharmacovigilance Guideline** (Final version November 2023, signed and searchable PDF on MoH site).
- National PV system comprises:
- National Pharmacovigilance section under interim NMRA.
- State Pharmacovigilance Focal Points.
- Hospital PV committees and healthcare facilities.
- Emphasis on detecting/reporting adverse reactions, substandard/falsified medicines, and ensuring medicine safety/efficacy.

**Organization and Personnel**
- Marketing Authorization Holders (MAHs)/importers/distributors must monitor safety and report ADRs to NMRA/MoH.
- No strict mandatory local **Qualified Person for Pharmacovigilance (QPPV)** or resident PV contact is detailed in public guidelines (system relies more on national coordination and focal points than stringent MAH obligations).
- No formal **PV System Master File (PSMF)** registration/location mandate.

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- HCPs (primary reporters), hospitals, patients, and MAHs report suspected ADRs (serious/unexpected prioritized), medication errors, quality issues, or lack of efficacy to NMRA/MoH (via standardized forms, digital tools, or institutional channels).
- Timelines: Not rigidly codified with fixed calendar days in the 2023 guideline (follows general WHO expectations); **prompt** reporting encouraged for serious/unexpected events to support signal detection. Serious cases prioritized.
- Reports analyzed for signals/causality; feed into national system and VigiBase.

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- No routine mandatory periodic submissions detailed publicly for all products.
- Safety updates may be required during registration/renewals, variations, or on request (aligned with basic WHO formats).

**Risk Management Plans (RMP)**
- Not a standard mandatory requirement for all products.
- Risk assessment handled reactively through national surveillance, NMRA evaluations, and public health program strategies.

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

**Clinical Trials-Related Safety Requirements**
Clinical trials in Somalia are limited (small scale, humanitarian-focused, or part of multi-country studies) and require MoH/NMRA authorization (ethics/regulatory review; aligned with international norms).
- Sponsors monitor safety and report serious adverse events/SAEs.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)** or equivalent: Expedited reporting required (aligned with international/ICH E2A norms; typically **7–15 days** for serious unexpected, faster for fatal/life-threatening; trial-specific or per approval rather than rigidly codified nationally).
- No dedicated national electronic system (e.g., no EudraVigilance/CTIS); reports submitted directly to MoH/NMRA (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 trials.
- Sponsor responsibility for monitoring, causality assessment, and communication to authorities/ethics committees.

**Additional Monitoring / Other Aspects**
- No black triangle/additional monitoring scheme.
- Strong focus on spontaneous reporting from HCPs/institutions, quality surveillance (substandard/falsified medicines), and public health programs.
- Inspections/audits by NMRA possible; ADR reporting volumes historically low (under-reporting common), but improving significantly with 2023 guideline rollout, training, digital tools, and WHO/Africa CDC support (targeted boost by end-2025).

Somalia's PV framework is **functional but minimalistic** and still developing — no stringent MAH obligations like mandatory local QPPV/PSMF/RMP for all, routine PSUR cycles, or highly detailed timelines compared to more advanced systems. It prioritizes national coordination, spontaneous reporting, and integration into health programs over complex industry bureaucracy.

For precise, product- or trial-specific requirements (e.g., current ADR forms from Nov 2023 guideline, exact timelines, or clinical trial submissions), consult the **National Medicines Regulatory Authority (NMRA)** or **Federal Ministry of Health** directly via moh.gov.so (or nmra.gov.so if active; pharmacovigilance section) or WHO partners, as the system continues to strengthen (e.g., digital adoption, training, and reporting targets through 2025–2026). Companies operating in Somalia typically align with WHO minimums and reference regional standards (e.g., East Africa Community) for compliance.