Quote from VigiServe Admin on November 25, 2020, 1:28 PM

**Pharmacovigilance Requirements in Ghana (as of January 2026)**

Ghana’s pharmacovigilance (PV) system is managed by the **Food and Drugs Authority (FDA Ghana)** under the **Public Health Act 2012 (Act 851), Section 125**. The **National Pharmacovigilance Centre** (within FDA’s Safety Monitoring and Clinical Trials Directorate) coordinates ADR/AEFI collection, signal detection, risk assessment, inspections, alerts, and contributions to VigiBase (via VigiFlow and PvERS electronic system). Ghana is a WHO PIDM full member.

Key guidelines (latest available):
- **Guideline on Qualified Person for Pharmacovigilance** (March 2025).
- **Guidelines for Safety Monitoring of Medicinal Products** (Version 04, 2019 with ongoing updates).
- **Guidelines for Reporting Adverse Drug Reactions** (2022).
- **Guideline on Conducting Good Pharmacovigilance Practices Inspections** (risk-based).

### Legal Framework and Governance
FDA Ghana enforces PV obligations for all registered medicinal products, biologics, vaccines, and herbal products. Emphasis on post-marketing surveillance, active PV in public health programs (HIV, TB, malaria, vaccines), and hospital/regional PV committees.

### Organization and Personnel
- Marketing Authorization Holders (MAHs)/local representatives must establish and maintain a PV system.
- **Qualified Person for Pharmacovigilance (QPPV)**: Mandatory local QPPV residing in Ghana (pharmacist or equivalent with PV experience; approved by FDA; serves as primary contact and oversees the system).
- **Pharmacovigilance System Master File (PSMF)**: Required to describe the PV system; maintained and available for FDA inspections (detailed content aligns with GVP principles).

### Individual Case Safety Reports (ICSRs) – Post-Marketing
- MAHs, HCPs, hospitals, patients, and others report suspected ADRs/AEFIs, quality issues, medication errors, or lack of efficacy via PvERS (preferred), paper forms, or email.
- **Timelines** (standard ICH-aligned):
- Serious ICSRs (unexpected or increased frequency): **15 calendar days** of receipt.
- Non-serious ICSRs: **90 calendar days** or periodic aggregates.
- Foreign ICSRs: Included in periodic reports if relevant.
- Coding: MedDRA preferred.

### Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)
- MAHs submit PSURs/PBRERs (ICH E2C(R2) format).
- Frequency: Typically every 6 months initially (first 2 years), then annually or as specified by FDA (during renewals, variations, or safety concerns).

### Risk Management Plans (RMP)
- Required for new chemical/biological entities, high-risk products, biologics, biosimilars, and generics (as needed).
- EU-style format with Ghana-specific annex (justifying local adaptations).
- Updates required for new risks or significant changes.

### Signal Management and Emerging Safety Issues
- MAHs continuously monitor global/local data and notify FDA of validated signals or emerging concerns promptly.
- FDA leads national signal detection (using VigiLyze and local data).

### Clinical Trials-Related Safety Requirements
Clinical trials require FDA approval (Clinical Trial Application per **Guidelines for the Conduct of Clinical Trials in Ghana** and GCP standards).
- Sponsors monitor safety and report to FDA’s Clinical Trials Unit.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**:
- Fatal/life-threatening SUSARs: **7 calendar days**.
- Other serious unexpected SUSARs: **15 calendar days**.
- **Development Safety Update Reports (DSURs)**: Annual submission required (ICH E2F format).
- Reports via FDA channels (electronic/forms); sponsor responsible for monitoring, causality assessment, DSMB (if applicable), insurance for trial-related injury, and communication to FDA/ethics committees (NHRC/IRB).

### Additional Monitoring / Other Aspects
- No black triangle scheme.
- Active surveillance for priority products (vaccines, antiretrovirals, high-risk drugs).
- Risk-based GVP inspections of MAH PV systems (QPPV compliance, PSMF, reporting).
- Patient/HCP reporting encouraged; electronic PvERS promoted.
- Focus on rational use, counterfeit detection, and public health programs.

Ghana’s PV framework is WHO/EAC-harmonized and maturing (strong mandatory local QPPV since 2025 guideline, GVP inspections, electronic reporting). It balances MAH obligations with national surveillance but is less prescriptive than full ICH/EU systems on routine PSUR frequency.

For the latest forms, exact timelines, or product-specific requirements, consult **FDA Ghana** directly via fdaghana.gov.gh (Safety Monitoring & Clinical Trials section, downloads, or contacts), as guidelines are periodically updated. Companies operating in Ghana must appoint a local QPPV and align with FDA GVP for compliance.

Would you like details on a specific area (e.g., QPPV registration, RMP annex, or vaccine AEFI surveillance)?