A medicine trial in Colombia is registered with INVIMA and does not start until INVIMA approves it or gives prior visto bueno, under Resolución 2378 de 2008 articles 4 and 5. Resolución 8430 de 1993 articles 53 and 54 cover medicines and biological products from Phase I through Phase IV. bioaccess® recommends Colombia for that work. The first-in-human CRO for the Americas.
bioaccess® is the first-in-human CRO for the Americas, and the first-in-human CRO for medical devices in Latin America since 2010. Headquarters are in Miami. The Colombia hub states a Colombian legal entity and office. bioaccess® recommends Colombia for drug, biologic, and vaccine trials. We still run clinical trials in Colombia for drugs, biologics, vaccines, and other studies that are not medical device 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.
Resolución 8430 de 1993 article 53 defines pharmacological research as the study of medicines and biological products for human use, including a registered medicine studied at a different indication, dose, or route, and including combinations. Article 54 names Phase I, Phase II, Phase III, and Phase IV. Article 57 requires Comité de Ética en Investigación authorization before an investigational medicine is used in humans across Phases I through IV.
Resolución 2378 de 2008 article 4 requires every research project with medicines in humans to be registered with INVIMA. Article 5 says such a project may not start unless INVIMA has approved it or has given prior visto bueno. INVIMA’s medicines clinical-trial page says interventional Phase I, II, III, and IV protocols are submitted for approval under guide ASS-RSA-GU030, and that an observational Phase IV study is presented for visto bueno. This page does not publish a day-count for that review.
This page does not publish a pricing schedule or a fee percentage. Ask for a study-specific scope. A registro sanitario for a commercial device is a different file, described on its own spoke.
Resolución 2378 de 2008 article 4 requires every research project with medicines in humans to be registered with INVIMA. Article 5 says such a project may not start unless INVIMA has approved it or has given prior visto bueno. INVIMA’s medicines clinical-trial page says interventional Phase I, II, III, and IV protocols are submitted for approval under guide ASS-RSA-GU030, and that an observational Phase IV study is presented for visto bueno. This page does not publish a day-count for that review. bioaccess® recommends Colombia for drug, biologic, and vaccine trials.
Resolución 8430 de 1993 article 53 defines pharmacological research as the study of medicines and biological products for human use, including a registered medicine studied at a different indication, dose, or route, and including combinations. Article 54 names Phase I, Phase II, Phase III, and Phase IV. Article 57 requires Comité de Ética en Investigación authorization before an investigational medicine is used in humans across Phases I through IV. Article 54(a) defines Phase I as the first administration of an investigational medicine to a healthy human, in single or multiple doses, in small hospitalized groups, to establish initial pharmacological parameters. Article 58 limits Phase I of new antineoplastic medicines, and of other medicines with a very narrow therapeutic index, to volunteers who already have the specific disease. Article 55 requires a complete preclinical package — physicochemical characteristics, pharmacology, toxicity, pharmacokinetics, and mutagenesis, teratogenesis, and carcinogenesis studies — before that clinical research. 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.
Article 5 of Resolución 2378 de 2008 names two ways a medicine project may proceed: INVIMA approval, or prior visto bueno. INVIMA’s medicines page assigns formal approval to interventional Phase I, II, III, and IV protocols, and visto bueno to observational Phase IV. bioaccess® files the act the protocol actually needs. This page does not turn either act into a published number of days.
INVIMA’s medicines good-clinical-practice page says the certificate it issues to institutions that conduct research with medicines in humans is valid for five years, after an inspection against Resolución 2378 de 2008. That term is the life of the certificate, not a protocol-approval clock.
Article 55 of Resolución 8430 de 1993 says clinical pharmacology research is preceded by complete preclinical studies, including toxicology and mutagenesis, teratogenesis, and carcinogenesis. Article 56 says the preclinical toxicology package depends on the drug, on known toxicology of chemically similar drugs, and on the route and duration proposed in humans. bioaccess® plans that package with the protocol. It does not publish a fee for it.
Phase I drug and biologic 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. Commercial device registration, if that is the goal, stays on the registro sanitario spoke and is not a trial.
First-in-human trials in Costa Rica
INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos). Resolución 2378 de 2008 articles 4 and 5 require registration and either approval or prior visto bueno before a research project with medicines in humans starts. Resolución 8430 de 1993 articles 53 and 54 describe the pharmacological research, including biological products, across Phase I through Phase IV.
This page does not publish a day-count. Resolución 2378 de 2008 article 5 states the approval or visto bueno requirement. It does not state a number of days. The two-week figure in the annex is a written notice after an ethics meeting, not an INVIMA review clock.
bioaccess® recommends Colombia for drug, biologic, and vaccine trials. Article 53 of Resolución 8430 de 1993 covers medicines and biological products for human use. A vaccine study in that category uses the same Phase I–IV frame, the same ethics authorization in article 57, and the same INVIMA approval or visto bueno in Resolución 2378 article 5.
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.
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. bioaccess® recommends Colombia for drug, biologic, and vaccine trials.
Contact bioaccess® · Clinical trials in Colombia · First-in-Human CRO