June 17, 2025

From May 2025, INVIMA (Colombia’s drug regulator) has new rules for pharmacovigilance to match global standards. These rules give Marketing Authorization Holders (MAHs) more responsibility to monitor drug safety after launch.

Key Updates

1. Local Pharmacovigilance Contact (LPPV)

  • Every MAH must appoint a licensed doctor or pharmacist living in Colombia.
  • This person (LPPV) must always be available for INVIMA.

2. Pharmacovigilance System Master File (PSMF)

  • Keep an updated PSMF in Spanish.
  • It must show how your safety system works, who is responsible, and what quality checks you use.
  • INVIMA can ask to see it anytime.

3. Individual Case Safety Reports (ICSRs)

  • Submit reports through INVIMA’s online system using MedDRA and WHO Drug codes.
  • Deadlines: Serious cases → within 15 days; non-serious → within 90 days.
  • If no side effects happen, send a quarterly “nil” report.

4. Periodic Safety Reports (PSUR/PBRER)

  • Prepare reports following EURD timelines.
  • Can be in English or Spanish, but if in English, add a Spanish summary.
  • Send reports when INVIMA asks.

5. Risk Management Plans (RMPs)

  • Needed for:
    • New drugs (first approval)
    • Biologics (first approval or renewal)
    • When new safety issues appear.

6. Operational Readiness

  • Set up a local PV team or work with local experts.
  • Make sure you can respond quickly and stay compliant.

MAH Compliance Checklist ?

  • Appoint a qualified LPPV in Colombia.
  • Keep an updated PSMF in Spanish.
  • Send ICSRs on time + quarterly nil reports.
  • Keep PSURs/PBRERs ready for INVIMA.
  • Submit or update RMPs when needed.
  • Decide if you’ll build your own PV team or outsource.

Why Compliance Matters

Following these rules:

  • Protects patients and public health.
  • Aligns your company with international standards.
  • Avoids penalties, delays, or lost approvals.

How Maven Can Help

Maven provides full PV support in Colombia:

  • LPPV appointment
  • Case reporting and management
  • Preparing safety reports
  • Regulatory strategy and guidance

Conclusion

Colombia’s new PV rules make drug safety stronger and closer to global best practices. For MAHs, acting early is key. By staying compliant—and working with local experts when needed—you can keep patients safe, meet INVIMA’s expectations, and keep your products on the market.