INOPP Forum
Pharmacovigilance Requirements in Colombia
Quote from VigiServe Admin on March 8, 2022, 1:52 AMIn Colombia, the pharmacovigilance system is mature, robust, and regulated by the National Institute for Food and Drug Surveillance (INVIMA). Recent regulatory updates (e.g., Resolución 2024015321) have further aligned the country with ICH, WHO, and PAHO guidelines, placing it among the more advanced PV frameworks in Latin America.
1. Clinical Safety (Clinical Trials)
Clinical trials require INVIMA authorization and ethics committee approval.
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) and SAEs to INVIMA.
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 periodically for ongoing trials.
Submission: Reports are submitted directly to INVIMA channels via forms, email, or online.
2. Post-Marketing Pharmacovigilance
Marketing Authorization Holders (Titulares del Registro Sanitario - TRS) must establish a risk-based PV program.
Personnel & Infrastructure:
Local QPPV: Mandatory. A Local Pharmacovigilance Contact/Person (LPPV)—a licensed physician or pharmacist residing in Colombia—must be appointed as the 24/7 primary contact for INVIMA.
PSMF: Docs Locally. There is no explicit requirement to register a PV System Master File, but comprehensive PV procedures and SOPs must be documented in Spanish and available for audits.
Incident Reporting (ICSRs):
Timelines:
Serious: Within 15 calendar days of awareness.
Non-Serious: Within 90 calendar days.
Nil Reports: Quarterly "nil" reports are required if no events are received.
Risk & Periodic Reporting:
PSURs: Mandatory. Frequency follows the EURD list or INVIMA directives (often every 6 months initially, then annually).
RMPs: Mandatory for new active substances, biologics, vaccines, and high-risk products.
Summary of Requirements
Component Requirement in Colombia Regulatory Authority INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) Framework Res. 2024015321 / ICH / PAHO Local QPPV / PSMF Yes (Local LPPV) / Docs Locally Safety Reporting 15 days (Serious) / 90 days (Non-Serious) Clinical Reporting SUSARs (7/15 days) Submission Language Spanish
In Colombia, the pharmacovigilance system is mature, robust, and regulated by the National Institute for Food and Drug Surveillance (INVIMA). Recent regulatory updates (e.g., Resolución 2024015321) have further aligned the country with ICH, WHO, and PAHO guidelines, placing it among the more advanced PV frameworks in Latin America.
1. Clinical Safety (Clinical Trials)
Clinical trials require INVIMA authorization and ethics committee approval.
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) and SAEs to INVIMA.
-
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 periodically for ongoing trials.
-
Submission: Reports are submitted directly to INVIMA channels via forms, email, or online.
2. Post-Marketing Pharmacovigilance
Marketing Authorization Holders (Titulares del Registro Sanitario - TRS) must establish a risk-based PV program.
-
Personnel & Infrastructure:
-
Local QPPV: Mandatory. A Local Pharmacovigilance Contact/Person (LPPV)—a licensed physician or pharmacist residing in Colombia—must be appointed as the 24/7 primary contact for INVIMA.
-
PSMF: Docs Locally. There is no explicit requirement to register a PV System Master File, but comprehensive PV procedures and SOPs must be documented in Spanish and available for audits.
-
-
Incident Reporting (ICSRs):
-
Timelines:
-
Serious: Within 15 calendar days of awareness.
-
Non-Serious: Within 90 calendar days.
-
-
Nil Reports: Quarterly "nil" reports are required if no events are received.
-
-
Risk & Periodic Reporting:
-
PSURs: Mandatory. Frequency follows the EURD list or INVIMA directives (often every 6 months initially, then annually).
-
RMPs: Mandatory for new active substances, biologics, vaccines, and high-risk products.
-
Summary of Requirements
| Component | Requirement in Colombia |
| Regulatory Authority | INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) |
| Framework | Res. 2024015321 / ICH / PAHO |
| Local QPPV / PSMF | Yes (Local LPPV) / Docs Locally |
| Safety Reporting | 15 days (Serious) / 90 days (Non-Serious) |
| Clinical Reporting | SUSARs (7/15 days) |
| Submission Language | Spanish |
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