## [INVIMA IVC-VIG-GU003: Updated Pharmacovigilance Guide for Periodic Safety Reports (PSUR)](/mandate/invima-ivc-vig-gu003-updated-pharmacovigilance-guide-for-periodic-safety-reports-psur) June 28, 2026 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. [Consult Now](/webform/consult%0A?url=https://preprod.freyrsolutions.com/markdownify/node/13673) Source [https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologic…](https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologicos/vigilancia-sqb) Select Mandate HA [INVIMA](/mandate-by-ha/invima) Select Mandate Function [Regulatory Affairs](/mandate-by-function/regulatory-affairs)