Quote from VigiServe Admin on November 28, 2020, 6:35 AM

Pharmacovigilance Requirements in Egypt

Egypt’s pharmacovigilance system is advanced, ICH-aligned, and strictly enforced by the Egyptian Drug Authority (EDA) and the Egyptian Pharmaceutical Vigilance Center (EPVC).

1. Clinical Safety (Clinical Trials)

Clinical trials require EDA approval and compliance with 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.

• Submission: Direct submission to the EDA.

2. Post-Marketing Pharmacovigilance

Marketing Authorization Holders (MAHs) must maintain a compliant pharmacovigilance system per Egyptian GVP guidelines.

• Personnel & Infrastructure:

  • Local QPPV: Mandatory. A Qualified Person for Pharmacovigilance resident in Egypt is required.

  • Pharmacovigilance System Master File (PSMF): Required. The file must be available for EDA inspections.

• Incident Reporting (ICSRs):

  • Timelines:

    • Serious: Within 15 calendar days.

    • Non-Serious: Within 90 calendar days.

• Risk & Periodic Reporting:

  • PSURs: Mandatory. Typically submitted every 6 months for the first two years, then annually.

  • RMPs: Mandatory for new substances, biologics, and high-risk products.

Summary of Requirements: Egypt

 

Component	Requirement in Egypt
Regulatory Authority	EDA (Egyptian Drug Authority) / EPVC
Framework	Egyptian GVP / ICH
Local Qualified Person for Pharmacovigilance	Yes
Pharmacovigilance System Master File	Yes
Safety Reporting	15 days (Serious) / 90 days (Non-Serious)
Clinical Reporting	SUSARs (7/15 days)
Submission Language	English / Arabic