Quote from VigiServe Admin on November 28, 2020, 5:59 AM

In Ethiopia, the pharmacovigilance system is regulated by the Ethiopian Food and Drug Authority (EFDA). The framework aligns with WHO minimum standards and is governed by the 2024 National Pharmacovigilance Guideline and Directive No. 932/2022.

1. Clinical Safety (Clinical Trials)

Clinical trials require EFDA authorization and adherence to ICH GCP standards.

• Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs).

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Periodic Reporting: Development Safety Update Reports (DSURs) are required annually or as requested.

• Submission: Direct submission to the EFDA via forms or email.

2. Post-Marketing Pharmacovigilance

Marketing Authorization Holders must establish a compliant pharmacovigilance system.

• Personnel & Infrastructure:

  • Local Qualified Person for Pharmacovigilance: Mandatory. A qualified professional residing in Ethiopia must be appointed (deadline October 2025).

  • Pharmacovigilance System Master File: Docs Locally. No formal registration is mandated, but standard operating procedures must be available for inspections.

• Incident Reporting (ICSRs):

  • Timelines: "Prompt" reporting is expected for serious and unexpected cases to support signal detection.

• Risk & Periodic Reporting:

  • PSURs: Submitted upon request, during renewals, or for variations.

  • RMPs: Reactive; not standard mandatory for all products.

Summary of Requirements: Ethiopia

Component	Requirement in Ethiopia
Regulatory Authority	EFDA (Ethiopian Food and Drug Authority)
Framework	WHO / Directive 932/2022
Local Qualified Person for Pharmacovigilance	Yes
Pharmacovigilance System Master File	Docs Locally
Safety Reporting	Prompt (Serious)
Clinical Reporting	SUSARs (7/15 days)
Submission Language	English

AEFI standard reporting form Ethiopia

ADE-ADR-ME-reporting form-EFDA