Colombia clinical trial regulatory guide

Regulator: INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos)

bioaccess® runs first-in-human studies in Colombia now, devices included. Resolución 8430 de 1993 articles 53 and 54 cover medicines and biological products from Phase I through Phase IV. Article 57 requires Comité de Ética en Investigación authorization before an investigational medicine is used in humans. Resolución 2378 de 2008 article 5 says a medicine-in-humans project may not start unless INVIMA has approved it or given prior visto bueno. This page does not publish a day-count for that review. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia. Device registro sanitario under Decreto 4725 de 2005 is market authorization, not a trial.

Approval process

1. Ethics authorization for a medicine trial. Article 57 of Resolución 8430 de 1993 requires Comité de Ética en Investigación authorization for Phases I through IV before an investigational medicine is used in humans.
2. INVIMA gate. Resolución 2378 de 2008 article 4 requires every research project with medicines in humans to be registered with INVIMA. Article 5 says the project may not start unless INVIMA has approved it or given prior visto bueno.
3. Where a device trial is led. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia.
4. Device market authorization. Decreto 4725 de 2005 article 17 covers automatic registro sanitario for class I and IIa devices that are not controlled technology. Article 16 covers the evaluated route for class IIb and III. That is commercial authorization, not a clinical trial.

Ethics requirements

• Comité de Ética en Investigación authorization under Resolución 8430 de 1993 article 57 for Phases I through IV of a medicine trial
• Institutional ethics committee under Resolución 2378 de 2008 article 7 at institutions that conduct research with medicines
• Protocol, consent form, and recruitment advertising in the committee package
• Written notice within two weeks after the meeting is a notice deadline, not a decision clock
• bioaccess® runs first-in-human studies in Colombia now, devices included

Documentation requirements

• Medicine-trial protocol registered with INVIMA under Resolución 2378 de 2008 article 4
• INVIMA approval or prior visto bueno under article 5 before the project starts
• Preclinical package required by Resolución 8430 de 1993 article 55 before clinical pharmacology research
• Spanish-language submissions to INVIMA and the ethics committee
• Device registro sanitario documents belong on the market-authorization spoke, not on a trial file

Device registration

Device registro sanitario under Decreto 4725 de 2005 is market authorization, not a clinical trial. Article 17 covers automatic registration for class I and IIa devices that are not controlled technology. Article 16 covers the evaluated route for class IIb and III. Decreto 582 de 2017 says INVIMA processes class IIb and III applications (only) in ninety business days once the file is complete (Decreto 582/2017 art. 1, https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_0582_2017.htm). Article 31 sets a ten-year term. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia.

FDA acceptance of Colombia data

Foreign drug and biologic data can be eligible for FDA submission and review under 21 CFR 312.120 when that rule’s conditions are met. Eligibility is not approval. Device data under 21 CFR 812.28 is the rule for a device study run in Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, or Colombia. bioaccess® runs first-in-human studies in Colombia now, devices included.

Key contacts

• INVIMA — National Regulatory Authority
• Ministry of Health — Health Policy & Oversight

Frequently asked questions

How long does INVIMA approval take for a clinical trial?

This page does not publish a day-count. For a medicine trial, Resolución 2378 de 2008 article 5 requires INVIMA approval or prior visto bueno before the project starts. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia.

Does bioaccess® recommend Colombia for a drug or biologic trial?

Yes. bioaccess® runs first-in-human studies in Colombia now, devices included. Resolución 8430 de 1993 articles 53 and 54 cover medicines and biological products from Phase I through Phase IV.

Is a local authorized representative required?

Commercial device registration and a medicine-trial file each have their own local-representative rules. bioaccess® can serve as the local representative the hub already states. bioaccess® runs first-in-human studies in Colombia now, devices included.

What language must documents be submitted in?

Submissions to INVIMA and ethics committees are made in Spanish.

Where is a medical device clinical trial led?

For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia. bioaccess® runs first-in-human studies in Colombia now, devices included.

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