Part 2: Beyond Registration — Traceability and Pharmacovigilance in Colombia

Getting a biosimilar approved by INVIMA is just the first milestone. What truly ensures its sustainability and credibility in the Colombian market comes afterward: the consistent fulfillment of two critical pillars—traceability and pharmacovigilance. These elements have been firmly consolidated by INVIMA as essential safeguards for patient safety and long-term product quality.

INVIMA REQUIREMENTS: BEYOND THE DOSSIER

Colombian regulation stands out in LATAM for its strong post-approval requirements. INVIMA mandates that companies implement:

• Traceability: It must be possible to track each batch from manufacturing to distribution through a system that enables rapid response in case of any issue.
• Pharmacovigilance: INVIMA requires ongoing, effective, and well-documented monitoring of adverse events, risk management plans, and active pharmacovigilance programs to assess safety under real-world conditions.

These demands go beyond mere compliance. They can become competitive advantages when addressed with strategic foresight. At Freyr, we support companies in meeting these requirements by offering guidance to implement effective monitoring systems and helping plan and execute robust risk management activities.

PHARMACOVIGILANCE: STAYING AHEAD OF RISK

Safety monitoring spans the entire product lifecycle. Pharmacovigilance must be implemented early in development and maintained through commercialization. It should be dynamic, sensitive, and tailored to the specific product.

In Colombia, marketing authorization holders must submit a Risk Management Plan (RMP) that includes:

• General safety specifications and product-specific risks
• A pharmacovigilance plan
• Post-authorization study plans
• Risk minimization measures

Many companies underestimate the complexity of these processes and treat them as afterthoughts. However, designing a pharmacovigilance strategy from the early stages can significantly reduce regulatory risks.

WHAT ABOUT THE REST OF THE REGION?

Colombia is not alone in raising regulatory standards. LATAM is clearly advancing:

🇧🇷 Brazil (ANVISA): Strengthening traceability requirements and imposing strict criteria for interchangeability.
🇲🇽 Mexico (COFEPRIS): Integrating monitoring technologies and reinforcing post-marketing study expectations.
🇦🇷 Argentina (ANMAT): Prioritizing continuous follow-up with a clinical and documentation-based focus.

This trend confirms a regional shift: patient safety is non-negotiable.

HOW TO PREPARE (WITHOUT BURNING OUT)?

✔️ Integrate pharmacovigilance into your regulatory planning—don’t wait until after approval.

✔️ Design your traceability system with INVIMA’s expectations and future LATAM markets in mind.

Freyr can help you anticipate, structure, and execute each of these elements from day one—minimizing risks and avoiding rework.

FREYR: YOUR STRATEGIC PARTNER FOR SMART COMPLIANCE

At Freyr, we help turn regulatory demands into competitive strengths. How?

✔️ We design traceability systems that comply with Colombian regulations and can be seamlessly integrated into your operations from the beginning.

✔️ We provide consultancy on proactive pharmacovigilance implementation across the product lifecycle—from system setup to the execution of post-marketing studies.

With our support, compliance stops being a burden and becomes a compelling case before the regulatory authority and the market.

IN SUMMARY

A well-prepared dossier opens the door. However, long-term business sustainability in Colombia depends on a company’s ongoing commitment to safety, traceability, and efficacy. Today, compliance alone isn’t enough; standing out means going further.