INVIMA IVC-VIG-GU003: Updated Pharmacovigilance Guide for Periodic Safety Reports (PSUR)

INVIMA updated IVC-VIG-GU003 on 28-May-2026 (original document date: 21-Jun-2023), introducing a comprehensive update to the PSUR regulatory framework integrating ICH E2C(R2)/PBRER standards with national regulatory expectations.

Policy Focus:

• Adoption of ICH E2C(R2)/PBRER framework for PSUR preparation, shifting from safety-only reporting to full benefit-risk evaluation.

Scope:

• Applicable to marketing authorization holders of medicinal products marketed in Colombia required to submit PSURs to INVIMA.

Key Requirements / Provisions:

• ICH E2C(R2)/PBRER Framework: Full benefit-risk evaluation replaces safety-only reporting.
• EURD List Alignment: Standardized reporting frequency and data lock points.
• Mandatory Submission Criteria: PSURs required based on risk criteria including biologics, high AE products, safety alerts, and PGR requirements.
• Standardized Structure: ~20 sections with detailed analytical requirements.
• Signal Management: Strong focus on risk characterization and effectiveness of risk minimization measures.
• Integrated Data Analysis: Real-world use, off-label use, special populations, and post-marketing data from multiple sources required.

Regulatory Goals:

• Align Colombian PSUR framework with ICH international standards.
• Strengthen post-marketing benefit-risk assessment.
• Improve pharmacovigilance signal management.