NEW INVIMA CONTINGENCY PLAN FREYR HELPS YOU NAVIGATE THIS REGULATORY OPPORTUNITY

 INVIMA has launched an exceptional plan to unblock thousands of regulatory procedures in Colombia. If your company is in the process of obtaining a marketing authorization, this is essential information.

While it doesn’t introduce immediate regulatory changes or set new official timelines, the plan signals the beginning of an operational transition: a phase aimed at enhancing INVIMA’s responsiveness, optimizing internal workflows, and reducing backlogs.

For pharmaceutical companies —both local and international— this represents a tactical window to move forward strategically, gain competitiveness, and accelerate market entry.

WHAT DOES THIS PLAN MEAN FOR PHARMACEUTICAL COMPANIES?

The Contingency Plan does not replace existing regulations or redefine processing timelines. However, Resolution 2025010547 does introduce concrete measures such as:

  • Redistribution of technical staff
  • Extended working hours
  • Prioritization of backlogged submissions

These actions could translate into real improvements for procedures that have been pending for months or even years.

WHAT’S THE CURRENT SITUATION?

Persistent bottlenecks

The scale of the challenge is clear. According to the 2025 INVIMA Procedures Observatory, published in April 2025 by the National Business Association of Colombia (ANDI), over 14,000 pending applications are currently under review by INVIMA’s Directorate of Medicines and Biological Products. Of these, approximately 5,700 were submitted before November 2023 and are part of a judicial evacuation plan.

The impact on the industry is evident:

  • 39% of companies affiliated with ANDI’s Pharmaceutical Chamber reported halting recruitment processes due to delays.
  • 26% of new investments in Colombia were postponed during 2024.

The lack of regulatory agility has become a barrier to growth, competitiveness, and timely access to medicines.

A STRATEGY TAILORED TO YOU: HOW FREYR SUPPORTS YOUR PROCESS

In this evolving landscape, partnering with Freyr —a global expert with deep regional insight— can make the difference between moving forward or getting stuck in red tape. Here’s how we can support you:

  • Comprehensive review of your current regulatory status and pending applications
  • Preparation of technical and legal documentation in line with Decree 334 of 2022
  • Smart regulatory strategies to meet INVIMA requirements efficiently and seamlessly
  • Design of forward-looking action plans with a strategic roadmap

TOWARD A MORE EFFICIENT REGULATORY SYSTEM

The new Contingency Plan aims to evolve INVIMA’s regulatory model toward a risk-based, agile approach. Although its implementation will be progressive, it is expected to reduce response times and align them with existing regulatory benchmarks.

The table below shows the standard timelines INVIMA aims to achieve. These figures should not be compared to current turnaround times (which in many cases exceed 400 days), but rather serve as a reference for the potential impact of a successful implementation.

Application Type

Target Timeline (per regulation)

New marketing authorization

Up to 180 calendar days

Minor changes (low risk)

1 month (immediate implementation + notice)

Moderate changes

Up to 3 months

Major changes

Up to 6 months

Safety/efficacy updates

Up to 10 months

WHAT’S NEXT?

It’s important to understand that INVIMA’s Contingency Plan is an opportunity, not an immediate guarantee. We are approaching a phase of gradual implementation focused on streamlining processes and adjusting to risk levels, but this will require time, internal changes, and collaboration across the sector.

Freyr offers strategic support to help you take full advantage of opportunities like this, with deep expertise in the Colombian regulatory environment and an international track record in over 120 countries.

📩 Looking for personalized guidance or want to learn more?
Get in touch with us.

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