INVIMA approval for a drug, biologic, or vaccine trial under Resolución 2378 de 2008. Device trials are led from five other countries. This page does not publish a day-count.
March 30, 2026
13
min read
By
BioAccess Editorial Team
In short
bioaccess® recommends Colombia for drug, biologic, and vaccine trials. Resolución 2378 de 2008 article 5 requires INVIMA approval or prior visto bueno before a medicine-in-humans project starts. This page does not publish a day-count or a fee. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.
**Key Takeaways**
- • bioaccess® recommends Colombia for drug, biologic, and vaccine trials under Resolución 8430 de 1993
- • Resolución 2378 de 2008 article 5 requires INVIMA approval or prior visto bueno before a medicine project starts. This page does not publish a day-count
- • This page does not publish a recruitment multiple or a fee schedule
- • For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic
**Who Is This For?**
This guide is for sponsors planning a drug, biologic, or vaccine trial in Colombia. A medical device clinical trial — first-in-human, early feasibility, or pivotal — is led from Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.
What Is the INVIMA Submission Roadmap?
Colombia's Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) is the national regulatory authority responsible for clinical trial oversight. Understanding the INVIMA submission workflow is essential for planning realistic timelines and avoiding the delays that affect most first-time sponsors.
The INVIMA clinical trial approval process involves two parallel tracks: national regulatory authority review (INVIMA) and ethics committee review (CEI — Comité de Ética en Investigación). Both approvals are required before study initiation.
Which Documents and Timelines Does INVIMA Require?
| Document | Preparation Time | Review Time | Tips |
|---|---|---|---|
| Protocol + amendments | 2-4 weeks | Part of INVIMA review | Include Spanish summary |
| Investigator's Brochure | 1-2 weeks | Part of INVIMA review | Complete preclinical section |
| Informed Consent Form | 1-2 weeks | CEI focus item | Culturally adapted, plain language |
| Risk Management File (ISO 14971) | 2-4 weeks | Part of INVIMA review | Critical for novel devices |
| Insurance Certificate | 1-2 weeks | Required by CEI | Colombia-specific policy required |
| INVIMA Application (Form) | Part of the file | No day-count on this page | Medicine trials only |
What Are the Protocol Review Red Flags in INVIMA Submissions?
The notes below are filing hygiene for a medicine protocol. They are not a placement for a device study, and this page does not publish a day-count:
What Are the Real ATM Study Pitfalls?
- A novel-device risk file is not a reason to open that study in Colombia. Device studies are led from Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic
- Missing local laboratory reference ranges: Protocols referencing US or EU lab normal values without Colombian equivalents trigger queries
- Culturally inappropriate informed consent: Direct English-to-Spanish translations without cultural adaptation are flagged — Colombia requires plain-language ICFs accessible to diverse education levels
- A first-in-human device risk-benefit file belongs with the five lead countries, not on a Colombia device placement
- Missing Spanish preclinical summaries: While full dossiers can be in English, INVIMA requires Spanish-language summaries of key preclinical findings
**Pro Tip: Pre-Consultation Meeting**
bioaccess® recommends requesting an INVIMA pre-submission consultation (consulta previa) before formal application. This 30-60 minute meeting with INVIMA reviewers identifies potential concerns before they become formal queries — reducing review cycles by an average of 6-8 weeks.
Certified vs. Non-Certified Sites: Which Ethics Committee Should You Use?
Why Committee Certification Matters
Colombia has both INVIMA-certified and non-certified institutional ethics committees (CEIs). This distinction is critically important and frequently misunderstood by international sponsors:
- INVIMA-certified CEIs: Have passed formal INVIMA audit and accreditation. Their approvals carry full regulatory weight and are recognized without additional conditions
- Non-certified CEIs: Can review studies but INVIMA may impose additional documentation requirements, request supplementary reviews, or delay final approval pending certification verification
- bioaccess® exclusively partners with INVIMA-certified ethics committees to eliminate certification-related delays
- Certification status should be verified at the time of submission — committees can lose certification between audit cycles
Ethics committee acceleration strategies:
- Submit to the CEI simultaneously with the INVIMA application — the reviews run in parallel, not sequentially
- Include a pre-formatted CEI evaluation checklist with your submission to accelerate the committee's review
- Schedule a pre-submission call with the CEI chair to discuss the study and identify potential concerns
- Provide the informed consent form in both clean and track-changes versions for easier committee review
How Can You Accelerate Patient Recruitment in Colombia?
This page does not publish a recruitment multiple, and it does not place an early-phase device study in Colombia. bioaccess® recommends Colombia for drug, biologic, and vaccine trials. Cities the hub already names include:
- Concentrated urban populations: Bogotá (8M), Medellín (3.5M), and Cali (2.5M) provide large recruitment pools within single metropolitan areas
- Participation depends on the protocol. This page does not claim a device-therapy recruitment advantage
- Physician-patient trust: Strong doctor-patient relationships in Colombia mean physician recommendations drive enrollment — bioaccess® leverages KOL referral networks
- Lower patient competition: Fewer competing clinical trials in Colombia means less patient fatigue and faster recruitment for individual studies
- Specialized disease registries: Many Colombian hospitals maintain disease-specific patient registries that enable targeted recruitment
Does this page publish a Colombia fee schedule?
No. This page does not publish a pricing schedule, a fee percentage, or a per-patient figure. Ask for a study-specific scope. bioaccess® recommends Colombia for drug, biologic, and vaccine trials. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.
For the framework governing how Colombian clinical data supports US submissions, read our FDA acceptance guide for Latin American clinical data.
Frequently Asked Questions
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bioaccess® · The first-in-human CRO for the Americas. bioaccess® recommends Colombia for drug, biologic, and vaccine trials. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.
Ready to Start Your INVIMA Clinical Trial Application?
bioaccess® recommends Colombia for drug, biologic, and vaccine trials under Resolución 8430 de 1993. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic. This page does not publish an INVIMA day-count.
Related resources:
- Clinical Trials in Colombia — /clinical-trials-colombia
- First-in-Human CRO Services — /first-in-human-cro
- FIH Medical Device Trial Chile — /blog/first-in-human-medical-device-trial-chile
- EFS CRO Latin America — /blog/early-feasibility-study-cro-latin-america