Colombia’s healthcare sector is undergoing a regulatory transformation. In a region where bureaucratic red tape and sluggish timelines have long delayed patient access to critical medical products, Colombia’s National Institute of Drug and Food Surveillance (INVIMA) has taken a bold step toward modernization. Under the leadership of Francisco Rossi, who assumed the official directorship in February 2024, INVIMA has introduced a comprehensive draft reform plan to streamline its regulatory processes, reduce backlogs, and promote faster access to life-saving medicines and medical devices.
With this strategic overhaul, INVIMA is signaling its intent to not just fix procedural inefficiencies but also reshape how Colombia collaborates with the pharmaceutical industry, improves public health outcomes, and positions itself as a regulatory model in Latin America.
Why This Matters
Historically, INVIMA has been associated with long approval timelines and opaque regulatory practices. Delays in market authorization have limited access to important health technologies, while local and international companies alike have struggled with complex requirements. This has impacted patients and weakened investor confidence and innovation in the Colombian pharmaceutical market.
The new reform plan, often referred to as a “contingency plan,” is INVIMA’s direct response to these long-standing challenges. It is a part of a broader institutional modernization initiative aimed at simplifying, automating, and accelerating the approval process across all medical product categories.
Core Components of the INVIMA Reform Plan
- Cell-Based Risk Assessment Model
INVIMA is introducing specialized internal working groups known as “cells.” These cells are responsible for:
- Evaluating a product’s risk level
- Categorizing the type and complexity of the regulatory process
- Defining the timeline for resolution
This triage-based approach allows INVIMA to prioritize high-risk or high-impact products, ensuring faster decisions where it matters most.
- Virtual Hearings for Real-Time Clarification
To address one of the biggest pain points, which is poor communication between applicants and the agency, INVIMA has implemented virtual hearings. These are scheduled interactions between license holders and INVIMA officials to:
- Resolve application-related doubts
- Clarify technical details
- Avoid unnecessary delays due to incomplete documentation
- Retrospective Application
Notably, the reform is not limited to future applications. It applies to all processes pending as of 30 December 2024, providing a lifeline to hundreds of submissions stuck in the pipeline.
Industry Endorsement Signals Positive Outlook
One of the most compelling aspects of the reform plan is its endorsement by AFIDRO, Colombia’s pharmaceutical industry association. Once one of INVIMA’s most vocal critics, AFIDRO has now commended the new direction. In a recent statement, AFIDRO’s director, Ignacio Gaitán, highlighted that an “agile, modern INVIMA” will ultimately benefit patients the most.
New Medical Device Platform: Another Key Milestone
Complementing the drug regulatory reforms, INVIMA also launched a new nomenclature and coding platform for medical devices and diagnostics in February 2025. This system:
- Helps license holders, manufacturers, and importers manage device usage more efficiently
- Facilitates traceability and surveillance
- Enhances supply chain transparency for faster responses to safety signals
This aligns with INVIMA’s broader mission to ensure post-market vigilance while fostering ease of compliance for the industry.
A Culture Shift at INVIMA
With the overhauling process, INVIMA is transforming its institutional culture:
- Nationwide outreach seminars are being held to update stakeholders about the reforms
- An internship program is being launched to attract young professionals to the regulatory field
- The agency is actively recruiting experienced personnel, especially in the medical devices and diagnostics review teams
All of these efforts indicate a sustained investment in building regulatory capacity and institutional trust.
Regional Context Across Latin America
While Colombia is progressing, its neighbors are navigating their own regulatory turbulence:
- In Chile, a generic drug manufacturer was recently fined for distributing substandard lamotrigine tablets.
- In Argentina, ANMAT shut down Laboratorios Ramallo due to repeated quality violations in IV solutions manufacturing.
- Meanwhile, Brazil’s ANVISA has updated its clinical trial manuals to align with ICH guidelines and the 2024 Brazilian Clinical Research Law, marking another milestone in Latin America’s regulatory evolution.
This regional backdrop makes INVIMA’s reforms even more significant, positioning Colombia as a potential regional leader in regulatory agility and transparency.
What It Means for Industry and Patients
For pharmaceutical and medical device companies, the new plan offers:
- Shorter approval timelines
- More transparent communication channels
- A structured, predictable framework for submissions
For patients, it means quicker access to essential medicines and technologies, a critical improvement for a country still facing healthcare disparities and post-pandemic recovery.
Conclusion
With its new reform plan, INVIMA is not just addressing past inefficiencies; it is laying the groundwork for a proactive, responsive, and industry-aligned regulatory system. If implemented effectively, this initiative could serve as a model for regulatory modernization across Latin America.
As Colombia embraces this new regulatory era, stakeholders across the pharmaceutical and medtech sectors should take note: a more agile and transparent INVIMA is already underway.
Need support navigating Latin America’s regulatory changes?
DDReg’s regional experts can help you align with INVIMA’s new framework and accelerate your market access strategy.
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