Conducting a clinical trial in Colombia involves more than obtaining INVIMA approval.
Foreign pharmaceutical companies, biotech companies and CROs must coordinate regulatory approval, ethics review, site qualification, healthcare-service habilitation, investigational-product logistics, safety reporting, data protection and contractual allocation of responsibilities.
A deficiency in any of these areas may affect submission, site activation or the ongoing operation of the study.
This guide explains the principal Colombian regulatory issues foreign sponsors and CROs should evaluate before conducting a clinical trial in Colombia.
Planning a Clinical Trial in Colombia?
We can review your proposed Colombian structure before submission or site activation and identify regulatory, contractual and operational issues requiring local action.
When Does a Drug Clinical Trial in Colombia Require INVIMA Approval?
In Colombia, the National Institute for Food and Drug Surveillance (INVIMA) is the competent health authority for the evaluation and authorization of clinical trials involving medicines in human subjects.
Under the current Colombian framework, Phase I, Phase II, Phase III and interventional Phase IV drug studies intended to be conducted in Colombia must be submitted to INVIMA through the Protocolos en Línea platform.
Before the regulatory submission is filed, the study must also have been reviewed by a Research Ethics Committee (Comité de Ética en Investigación or CEI) associated with an institution certified in Good Clinical Practices.
Foreign regulatory approval does not replace the Colombian process. Authorization by the FDA, EMA or another foreign regulator does not eliminate the need to comply with the Colombian regulatory pathway.
Medical-device clinical investigations follow a different regulatory route and should therefore be assessed separately.
For foreign sponsors: The Colombian regulatory pathway should be confirmed before adapting the global dossier or committing to a local site-activation timeline.
Before Selecting a Colombian Research Site, What Should a Sponsor Verify?
Site qualification in Colombia requires more than confirming that the institution has experience conducting clinical research.
A foreign sponsor should distinguish between at least two separate regulatory controls.
First, the research institution must comply with the Good Clinical Practice requirements applicable to clinical research with medicines and, where required, hold the corresponding certification issued by INVIMA.
Second, if the institution acts as a healthcare provider, the sponsor should verify that the healthcare services actually required to perform the protocol are duly habilitated under the Colombian healthcare-provider framework.
These are separate regulatory analyses. A site may therefore require review both from the clinical-research perspective and from the healthcare-service habilitation perspective.
Why this matters: Discovering a site deficiency after the institution has already been selected, contracted or incorporated into the global study timeline may create avoidable delays and contractual issues.
How Should Sponsor and CRO Responsibilities Be Allocated in Colombia?
Colombian regulation recognizes that a Contract Research Organization (CRO) may perform one or more functions related to the clinical trial on behalf of the sponsor.
In practice, a CRO may participate in regulatory submissions, site coordination, monitoring, pharmacovigilance, document management and other operational activities.
However, the delegation of functions should be clearly documented. The sponsor–CRO agreement should specify which party is responsible for each regulatory and operational obligation arising in Colombia.
Particular attention should be given to responsibilities involving INVIMA submissions, Ethics Committee communications, amendments, informed-consent updates, safety reporting, investigational-product imports, biological-sample exports, monitoring, annual reporting and study closure.
Practical consideration for foreign sponsors
A Colombian Sponsor–CRO Responsibility Matrix can help identify whether the allocation contained in a global CRO agreement actually covers the obligations that arise under Colombian regulation.
What Should Be Included in the Initial INVIMA Clinical Trial Submission?
The initial submission to INVIMA requires a structured regulatory dossier.
According to the current INVIMA guidance identified in the regulatory review, the submission may include, among other documents:
- the clinical protocol in Spanish and English;
- the applicable INVIMA verification form;
- Ethics Committee documentation and approval;
- the Investigator’s Brochure;
- informed-consent documents;
- site and investigator documentation;
- the applicable insurance policy;
- Good Manufacturing Practice documentation for the manufacturer; and
- technical and quality documentation relating to the investigational product.
The exact documentation should be confirmed for the specific study and product before filing.
Commercially important: A sponsor should not treat the Colombian submission as a simple local translation of the FDA or EMA dossier. Local ethics, insurance, site and product-documentation requirements need to be mapped separately.
What Regulatory Obligations Continue After INVIMA Approval?
INVIMA approval is not the end of the Colombian regulatory process.
During the conduct of the study, the sponsor and, where applicable, the CRO must continue to manage regulatory obligations relating to amendments, new sites, new investigators, informed-consent changes, safety information and other changes affecting the approved study.
The regulatory review also identifies obligations involving annual reports, pharmacovigilance, investigational-product traceability, monitoring, quality assurance and maintenance of essential documentation.
Relevant amendments generally require approval before implementation, except where urgent measures are necessary to eliminate an immediate risk to participants.
At the end of the study, the sponsor must also address the regulatory closure process, including final documentation and investigational-product accountability.
Safety reporting requires particular attention
For serious adverse events occurring in Colombia, the source material identifies reporting obligations involving the investigator, sponsor, Ethics Committee and INVIMA, including a 24-hour reporting period to the sponsor and Ethics Committee and a seven-business-day period for the sponsor or CRO to report to INVIMA, together with the applicable follow-up.
For global sponsors: Colombian safety-reporting obligations should be incorporated into the global pharmacovigilance SOPs and escalation calendar.
How Should Investigational Products and Biological Samples Be Managed Across Borders?
Investigational-product logistics and biological-sample transfers should be addressed early in the Colombian regulatory strategy.
INVIMA has a specific procedure for applications related to the importation of clinical-trial supplies and the exportation of biological samples associated with clinical-research protocols.
The investigational product must remain identifiable and traceable throughout the study, including records concerning shipment, receipt, return and destruction.
Where biological samples will be exported, the relevant documentation should address matters such as the type of sample, purpose of the analysis, storage conditions, destination and the party responsible for the process.
The regulatory strategy should also be aligned with the protocol and informed-consent documentation.
In practice, sponsors should address two separate workstreams
Investigational product
- Importation
- Storage
- Receipt
- Accountability
- Return or destruction
Biological samples
- Type of sample
- Purpose of analysis
- Destination
- Storage conditions
- Responsible party
- Confidentiality
- Informed-consent coverage
What Should Foreign Sponsors Know About Clinical Data, Medical Records and Cross-Border Transfers?
Clinical trials involve health information and other categories of sensitive personal data that are subject to Colombian data-protection requirements.
Foreign sponsors should identify the roles of the sponsor, CRO, research site and other providers in the processing of personal data and determine whether the relevant data flows constitute international transfers or international transmissions.
This distinction can be legally relevant under the Colombian data-protection framework.
Medical records are also subject to confidentiality rules, while biological samples, genetic studies, pharmacogenomic analyses and future uses of samples should be appropriately reflected in the protocol, informed consent and regulatory documentation.
Where samples are transferred outside Colombia, the regulatory requirements applicable to their export must also be considered.
For international sponsors: Compliance with GDPR, HIPAA or a global privacy policy does not by itself resolve the Colombian legal analysis of clinical-data flows.
Why Do Advanced Therapies Require an Early Colombian Regulatory Assessment?
Cell therapies, gene therapies, CAR-T products and other highly personalized treatments may require a more complex Colombian regulatory analysis.
The source material notes that advanced therapies may raise additional issues relating to product classification, manufacturing, quality, importation, biological samples, genetic information and long-term safety.
For these products, a sponsor should not assume that the regulatory classification or pathway adopted by FDA or EMA will automatically determine the Colombian approach.
An early regulatory assessment may therefore be particularly valuable before the sponsor finalizes the Colombian operational structure, selects sites or commits to an importation and sample-handling strategy.
Advanced-therapy sponsors should address classification and regulatory pathway questions before site activation, rather than after the Colombian study structure has already been established.
What Should Be Included in the Initial INVIMA Clinical Trial Submission?
Do Not Treat the Colombian Submission as a Translation Exercise
A Colombian clinical-trial submission should not be approached as a simple translation or administrative adaptation of an FDA, EMA or other foreign regulatory dossier.
Local requirements must be mapped independently, particularly in relation to Ethics Committee documentation, informed consent, insurance, site and investigator documentation, manufacturing evidence, and technical and quality information relating to the investigational product.
For foreign sponsors: the Colombian submission strategy should be reviewed before filing to identify local gaps that may not be addressed in the global regulatory package.
Planning a Clinical Trial in Colombia? Request a Regulatory Readiness Assessment
Nieto & Nieto Lawyers advises foreign pharmaceutical companies, biotech companies, sponsors and CROs on the Colombian legal and regulatory workstream of clinical trials.
A Colombia Clinical Trial Regulatory Readiness Assessment can be used to identify legal and regulatory issues before submission or site activation, including:
- INVIMA regulatory pathway;
- site qualification;
- sponsor–CRO responsibility allocation;
- Ethics Committee requirements;
- investigational-product logistics;
- biological-sample exports;
- clinical-data flows;
- insurance and indemnity issues;
- Clinical Trial Agreements; and
- ongoing Colombian regulatory obligations.
What Regulatory Obligations Continue After INVIMA Approval?
INVIMA Approval Is Not the End of the Regulatory Process
Authorization of the initial protocol is only one stage of the Colombian regulatory lifecycle.
During the study, sponsors and CROs may need to manage ongoing obligations relating to amendments, new sites and investigators, informed-consent changes, safety information, annual reporting, pharmacovigilance, investigational-product traceability, monitoring and maintenance of essential documentation.
At study completion, the regulatory workstream continues through closure, final documentation and investigational-product accountability.
- INVIMA Approval
- Amendments
- Safety Reporting
- Annual Reporting
- Product Accountability
- Study Closure
For global sponsors: these Colombian obligations should be incorporated into the study’s regulatory calendar and operational responsibilities from the outset.
