Colombia’s New Pharmacovigilance Regulations: What Marketing Authorization Holders Need To Know

Effective May 2025, INVIMA has introduced updated pharmacovigilance (PV) regulations to align with global safety standards.

These changes significantly increase responsibilities for Marketing Authorization Holders (MAHs), requesting:

• Stronger local presence 
• Enhanced safety reporting systems 
• Greater accountability in post-market monitoring 

The goal is to ensure continuous drug safety oversight and patient protection in Colombia.

What is Colombia’s new pharmacovigilance requirements?
Colombia’s updated pharmacovigilance regulations require MAHs to appoint a local pharmacovigilance contact (LPPV), maintain a Spanish PSMF, submit ICSRs within defined timelines, prepare PSUR/PBRER reports, and implement risk management plans aligned with global standards.

Key Regulatory Updates

1. Local Pharmacovigilance Contact (LPPV)

• Mandatory appointment of a licensed physician or pharmacist residing in Colombia 
• Must be continuously available for communication with INVIMA 
• Acts as the primary contact for safety-related queries and inspections 

2. Pharmacovigilance System Master File (PSMF)

• Must be: 
  • Maintained in Spanish 
  • Regularly updated 
• Should include: 
  • PV system structure 
  • Roles and responsibilities 
  • Quality management processes 

INVIMA may request the PSMF at any time for inspection.

3. Individual Case Safety Reports (ICSRs)

• Submission via INVIMA’s electronic reporting system 
• Use standardized coding: 
  • MedDRA 
  • WHO Drug Dictionary 

ICSR Reporting Timelines

4. Periodic Safety Reports (PSUR/PBRER)

• Must align with EURD timelines 
• Language requirements: 
  • English or Spanish 
  • Spanish summary required if submitted in English 

Submitted upon request by INVIMA.

5. Risk Management Plans (RMPs)

RMPs are mandatory for:

• New product approvals 
• Biologics (initial approval and renewals) 
• Products with emerging safety concerns 

RMPs ensure proactive identification and mitigation of risks.

6. Operational Readiness

MAHs must ensure:

• Local PV infrastructure or partnerships 
• Rapid response capability 
• Continuous compliance monitoring 

MAH Compliance Checklist

Why Compliance Matters

Adhering to these regulations:

• Protects patient safety and public health 
• Aligns with global pharmacovigilance standards 
• Prevents: 
  • Regulatory penalties 
  • Product approval delays 
  • Market access risks 

Common Challenges for MAHs

Best Practices for Implementation

• Appointing a qualified and experienced LPPV 
• Maintain a living PSMF document 
• Automate ICSR reporting workflows 
• Align global and local PV systems 
• Conduct regular internal audits and training 

Quick Facts

• New PV rules effective from May 2025 
• LPPV must be locally based in Colombia 
• ICSRs require strict timelines (15/90 days) 
• PSMF must be maintained in Spanish 
• RMPs required for high-risk products 

Why Local PV Compliance Is Critical

Strong pharmacovigilance systems require regulatory expertise, local presence, and operational experience. With stricter oversight from INVIMA, MAHs must demonstrate accountability, transparency, and data integrity. Companies that invest in compliant PV systems build trust, regulatory credibility, and long-term market success.

How Maven Scientific Laboratories Supports Colombia PV Compliance

Our Services

• LPPV appointment and local representation 
• ICSR case processing and reporting 
• PSMF preparation and maintenance 
• PSUR/PBRER authoring and submission support 
• RMP development and updates 

Why Choose Maven

• Strong Latin America regulatory expertise 
• End-to-end pharmacovigilance support 
• Local + global compliance alignment 
• Audit-ready systems and documentation 

Stay Compliant with Colombia’s New PV Rules

Expanding into Colombia or updating your PV system?

Partner with Maven Scientific Laboratories for efficient, compliant, and locally aligned pharmacovigilance solutions

• Ensure INVIMA compliance
•  Strengthening safety monitoring
•  Maintain uninterrupted market access

Conclusion

Colombia’s updated pharmacovigilance regulations mark a significant step toward global harmonization and enhanced patient safety.

For MAHs, early preparation, strong local presence, and robust PV systems are essential to meet these evolving requirements.

By adopting a proactive approach and leveraging expert support, companies can ensure compliance, protect patients, and sustain their presence in Colombia’s growing pharmaceutical market.

FAQs 

1. Who regulates pharmacovigilance in Colombia?
INVIMA.

2. What is an LPPV?
A local pharmacovigilance contacts responsible for safety reporting.

3. What language is required for PSMF?
Spanish.

4. What are ICSR timelines?
15 days for serious cases, 90 days for non-serious.

5. Are PSURs mandatory?
Yes, when requested by INVIMA.

6. How can Maven help?
By providing full pharmacovigilance and regulatory support.