Quote from VigiServe Admin on May 25, 2024, 5:42 AM

In Iraq, the pharmacovigilance system is managed by the Ministry of Health (MoH) through the Iraqi Pharmacovigilance Center (IPvC). The system aligns with WHO standards and Arab Good Pharmacovigilance Practices, with a transition to mandatory electronic submissions required in 2026.

1. Clinical Safety (Clinical Trials)

Clinical trials require MoH approval and ethics committee review.

• 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 MoH/IPvC.

2. Post-Marketing Pharmacovigilance

• Personnel & Infrastructure:

  • Local Qualified Person for Pharmacovigilance: Mandatory. A local safety responsible person resident in Iraq is required in practice.

  • Pharmacovigilance System Master File: Docs Locally. No formal registration is mandated, but pharmacovigilance procedures must be documented and available.

• Incident Reporting (ICSRs):

  • Timelines: "Prompt" reporting is expected for serious and unexpected cases.

• Risk & Periodic Reporting:

  • PSURs: Required during registration renewals, variations, or upon request.

  • RMPs: Required for new/high-risk substances and biologics.

Summary of Requirements

Component	Requirement in Iraq
Regulatory Authority	MoH / IPvC
Framework	WHO / Arab GVP
Local Qualified Person for Pharmacovigilance	Yes (Local Responsible)
Pharmacovigilance System Master File	Docs Locally
Safety Reporting	Prompt
Clinical Reporting	SUSARs (7/15 days)
Submission Language	English / Arabic