##  [NEW INVIMA CONTINGENCY PLAN FREYR HELPS YOU NAVIGATE THIS REGULATORY OPPORTUNITY](/index%2ephp/blog/new-invima-contingency-plan-freyr-helps-you-navigate-this-regulatory-opportunity) 

    May 28, 2025 

  ![NEW INVIMA CONTINGENCY PLAN FREYR HELPS YOU NAVIGATE THIS REGULATORY OPPORTUNITY]()

2 min read 

- [Medicinal Products](/index%2ephp/blog-main-categories/medicinal-products)
- [Regulatory Affairs](/index%2ephp/blog-main-categories/regulatory-affairs)





 

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.**](javascript:void(0))