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Tag: multi-country clinical trials

  • Clinical trial execution in Colombia: why we recommend it now

    Colombia is now in scope for bioaccess® clinical-trial execution across all phases — first-in-human through pivotal — for both medical devices and drugs, in every indication. That is a reversal of our prior position, and the reason is that the regulator changed faster than the market narrative about it did.

    INVIMA is one of eight national authorities certified by PAHO as a Regional Reference Regulatory Authority at Level IV, the highest level PAHO assigns for medicines regulation and surveillance in the Americas (INVIMA, Cooperación internacional; PAHO, Autoridades Regulatorias de Referencia). Since 2022 it has built a dedicated clinical-research group for devices, published its own approval and non-approval registries, and opened a public study search. Sponsors are still pricing Colombia on 2018 assumptions.

    What changed since 2022

    Three institutional facts, all documented by INVIMA itself.

    First, devices got their own clinical-research function: INVIMA created the Grupo de Investigación Clínica y Apoyo a Sala Especializada DMRDIV (GICASE) through Resolución 2022035262 of 20 September 2022 (INVIMA, Investigación Clínica — Dispositivos). Second, the Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro (SEDMRDIV) now has an explicit mandate to evaluate and issue technical and methodological opinions on research protocols involving devices and in vitro diagnostic reagents (INVIMA, Sala especializada DMRDIV). Device sponsors have a named technical body, not an improvised one.

    Third, INVIMA publishes what it approves and what it refuses: a register of device clinical studies approved from 2021 onward, a parallel register of studies not approved with the reason for each — non-approval, withdrawal, pending response — and a register of ethics-committee and research-site inspection status to November 2025 (INVIMA, Investigación Clínica — Dispositivos; register of non-approved device studies). Very few regulators in the region publish their rejections, and that register shows which protocol defects cost applicants a cycle. INVIMA’s public study search lists 1,157 clinical studies, 1,156 of them approved, 487 in progress and 523 completed, with a data date of 12 August 2026 (INVIMA, Lista de Estudios Clínicos).

    The device pathway: prototype authorization through pivotal

    Colombia has no single device clinical-trial regulation. It has three working instruments, and knowing which one carries which obligation is most of the job.

    Decreto 4725 de 2005 is the sanitary regime for human-use medical devices. Article 2 defines a device intended for clinical investigation as one used by a specialist physician in research in an appropriate human clinical setting. Article 36 provides that a national or imported prototype device — or controlled-technology biomedical equipment — may be authorized only for research and experimentation, may not be used in health care, and requires an INVIMA technical opinion. Article 48(b) is the import hook: exceptional importation without sanitary registration or commercialization permit where the device is the subject of clinical research authorized in Colombia, subject to a prior opinion from the relevant specialized chamber. Article 18(k) closes the loop commercially — class IIb and III devices must present clinical studies to demonstrate safety and effectiveness when they later seek Registro Sanitario (Decreto 4725 de 2005).

    Resolución 8430 de 1993 supplies the human-subjects framework — the scientific, technical and administrative rules for health research, including new prophylactic, diagnostic, therapeutic and rehabilitative resources (MinSalud) — and INVIMA names it as the governing instrument for research with human beings.

    The operative paperwork is form-driven and published: ASS-RSA-FM085 (checklist for the prototype-device technical-opinion request), ASS-RSA-FM172 (SEDMRDIV technical-opinion request), ASS-RSA-FM169 (initial study evaluation completed by the ethics committee), ASS-RSA-FM170 (periodic reports) and ASS-RSA-FM171 (serious adverse event notification) (INVIMA, Investigación Clínica — Dispositivos). There is no ambiguity about what to file. There is considerable skill in filing it in a form the SEDMRDIV will not bounce.

    The drug pathway

    For medicines the anchor is Resolución 2378 de 2008, which adopted Good Clinical Practices with mandatory application for institutions conducting research with medicines in human beings (INS, Resolución 2378 de 2008). INVIMA requires approval for Phase I, II and III protocols and for Phase IV protocols with intervention; non-interventional Phase IV studies must still be submitted with a summary so INVIMA can determine whether formal approval applies (INVIMA, Fiscalización de Ensayos Clínicos).

    Initial protocol evaluation is filed through Protocolos en Línea, the exclusive route for that procedure since 2 January 2020, under tariff 4070 for protocols and 4083 for amendments; adverse-event content and periodicity are set by Resolución 2011020764 de 2011, issued under Article 146 of Decreto 677 de 1995 (INVIMA, Fiscalización de Ensayos Clínicos).

    Import of unregistered investigational medicines runs through Article 96 of Decreto 677 de 1995, which lets INVIMA exceptionally authorize importation without sanitary registration where INVIMA or the Ministry has authorized clinical research in the country, following a Comisión Revisora opinion and against a free-sale certificate, corporate documentation and analysis-fee receipts (Decreto 677 de 1995). Where the investigational product is a controlled substance, the monopoly is administered by the Fondo Nacional de Estupefacientes, and INVIMA expressly prioritizes those files in its current contingency plan (Resolución 2025046281 de 2025). Sponsors sometimes look for a separate narcotics department in the trial pathway; the correct counterparty is the FNE, and only for controlled product.

    Timelines, and what the misconception gets wrong

    The complaint about Colombia is that it is slow and unpredictable. Half of that is true.

    Protocol volume has been flat for a decade — roughly 90 protocol-evaluation requests a year, 85 in 2014 and 87 in 2024 — and INVIMA’s average time to a definitive concept, approving or rejecting, is 5.1 months (ConsultorSalud, June 2025). Five months to a decision is not fast. It is a measured average with a published rejection register behind it, which makes it forecastable — unpredictability is the charge that does not survive contact with the data.

    Country Published regulatory clock for trial authorization Source
    Colombia No statutory day-count; measured 5.1-month average to a definitive INVIMA concept ConsultorSalud
    Argentina Disposición ANMAT 7516/2025 Art. 5 assigns evaluation to the Dirección de Investigación Clínica, states no day-count Boletín Oficial
    Chile ISP: 45 business days to authorize import of unregistered pharmaceutical products for trial use ISP Chile
    Panama Decreto Ejecutivo 21 de 2026 regulates Títulos III–IV of Ley 84 de 2019; no day-count published MINSA Panamá

    Three of the four comparators publish no binding clock at all. Colombia’s disadvantage on early-phase device work is smaller than the reputation suggests, and Colombia is the only one of the four that publishes both its approvals and its refusals.

    Sites: Bogotá, Medellín, Cali

    Colombia’s population was estimated at 53 million in 2025 (DANE, July 2025), and by December 2024 more than 160 centres held INVIMA Good Clinical Practice certification (ConsultorSalud).

    INVIMA’s own register of approved research ethics committees places them in Bogotá, Medellín, Cali, Floridablanca and Montería, attached to established IPS and medical foundations (INVIMA, CEI list to May 2025). Bogotá, Medellín and Cali are the tier-1 clusters — high-volume tertiary hospitals, certified pharmacy and clinical-laboratory services inside the same certified institution, and investigator populations that read English protocols without translation. Floridablanca (Santander) and Montería extend regional recruitment reach.

    Ethics committees

    A Colombian trial needs a CEI approved by INVIMA and a site holding a current BPC certificate. That certificate is issued to the IPS after INVIMA verifies compliance with Resolución 2378 de 2008 through inspection visits, runs for five years, and requires evidence that the institution is registered under the Sistema Único de Habilitación with authorized pharmaceutical service, clinical laboratory and sample-collection services (INVIMA, Certificaciones en BPC). Replacing a site’s ethics committee is a formal BPC modification requiring a new-conditions verification visit and a written transfer plan agreed with sponsor, CRO and both committees. Sponsors who treat CEI selection as an afterthought lose weeks here.

    Post-trial access in Colombia

    Colombia does not currently mandate post-trial access by statute. Resolución 2378 de 2008 and Resolución 8430 de 1993 were both read in full for post-trial supply language and neither contains it; Resolución 8430 allocates only harm-related costs (Arts. 13, 15(j)–(k), 58(c)). bioaccess® can operate voluntary continuity programs in Colombia on sponsor request. Statutory PTA mandates in Latin America currently apply to Argentina, Brazil, Panama, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras and Nicaragua — not Colombia.

    What is coming, and why it favours moving now

    Three reform tracks are live. A draft unified sanitary regime would replace Decreto 4725 de 2005 and Decreto 3770 de 2004, adding conditional indefinite authorizations, international reliance mechanisms, mandatory UDI from first filing, four IVD risk classes on IMDRF parameters and an 18-month transition; it cleared national consultation and went to WTO public consultation (ConsultorSalud, June 2026). MinSalud has circulated a draft resolution on health research with human beings that would partially repeal Resolución 8430 de 1993 (ConsultorSalud, February 2026). And a clinical-research framework bill filed in the Cámara in August 2025 by Senator Fabián Díaz Plata and Representative Juan Daniel Peñuela Calvache would adopt ICH E6 and ISO 14155:2020 as the regulatory standard, create an INVIMA registry of authorized CROs and accredited investigators, and impose tacit approval — INVIMA objects within 7 calendar days for common-risk research and 30 for high-risk research, with ratification in a further 5 days (Cámara de Representantes, bill text). It classifies first-in-human studies and novel implantable devices as high-risk.

    None is law yet. All three point the same direction, and each rewards sponsors who already hold Colombian sites, a certified CEI relationship and an INVIMA filing history when a transition period starts.

    Registro Sanitario sits at the far end of the same pathway

    Registro Sanitario is the INVIMA marketing authorization that lets a device be sold in Colombia, granted under Decreto 4725 de 2005 with technical evaluation under Article 18 and legal evaluation under Article 19; INVIMA may issue one request for additional information, with 90 days to respond, and BPM and CCAA certificates run for five years (Decreto 4725 de 2005). bioaccess® already runs Registro Sanitario market access in Colombia, and the reason to place trial and registration with one operator is Article 18(k): the clinical evidence a class IIb or III sponsor generates in Colombia is the evidence its Colombian registration will later be judged on.

    Planning a first-in-human or pivotal trial in Colombia? bioaccess® is a US-headquartered, LATAM-native operator running regulatory submissions, importadora functions and 2–8 °C GDP cold chain across the region, and Colombia is now in scope for all phases, all indications, devices and drugs. To discuss INVIMA feasibility, site selection in Bogotá, Medellín or Cali, or a combined trial-plus-Registro-Sanitario pathway, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    Does bioaccess® conduct clinical trials in Colombia?
    Yes. As of September 2026 Colombia is in scope for bioaccess® clinical-trial execution across all phases, from first-in-human through pivotal, in all indications, for both medical devices and drugs. This is a change from our earlier position. The reversal follows documented institutional improvement at INVIMA since 2022 — a dedicated device clinical-research group, a named specialized chamber for device protocols, published approval and non-approval registries, and a public study search — combined with our own operating capability in Bogotá, Medellín and Cali. bioaccess® also runs INVIMA Registro Sanitario market access in Colombia, so the trial and the eventual marketing authorization can be sequenced by one operator.

    What is INVIMA’s role in Colombian clinical trials?
    INVIMA authorizes, monitors and can halt clinical research in Colombia. It evaluates both clinical aspects and the quality of the investigational product, requires approval for Phase I, II and III protocols and for interventional Phase IV protocols, and requires submission of non-interventional Phase IV studies so it can determine whether formal approval applies. It may interrupt an investigation or require modifications at any time if authorization conditions change, Good Clinical Practice is not met, or participant or public-health protection requires it. Sponsor-to-CRO delegations must be reported to INVIMA and remain the sponsor’s responsibility.

    What is the INVIMA clinical-trial pathway for medical devices?
    Three instruments combine. Decreto 4725 de 2005 Article 36 authorizes prototype devices for research and experimentation only, against an INVIMA technical opinion; Article 48(b) permits exceptional importation without sanitary registration where the device is the subject of clinical research authorized in Colombia, following a prior opinion from the specialized chamber; Article 18(k) later requires clinical studies for class IIb and III Registro Sanitario. Resolución 8430 de 1993 supplies the human-subjects rules. The SEDMRDIV issues the technical and methodological opinion, supported since September 2022 by the GICASE group created under Resolución 2022035262.

    What is the INVIMA clinical-trial pathway for drugs?
    Resolución 2378 de 2008 adopted Good Clinical Practices with mandatory application for institutions researching medicines in humans, and is the basis of the site BPC certificate. Initial protocol evaluation is filed through INVIMA’s Protocolos en Línea platform, exclusive for that procedure since 2 January 2020, under tariff 4070 for protocols and 4083 for amendments. Adverse-event reporting content and periodicity follow Resolución 2011020764 de 2011, issued under Article 146 of Decreto 677 de 1995. Importation of unregistered investigational medicines runs under Article 96 of Decreto 677 de 1995 with a Comisión Revisora opinion. Controlled substances involve the Fondo Nacional de Estupefacientes, which administers that monopoly.

    What are typical INVIMA authorization timelines in 2026?
    There is no statutory day-count in force for protocol authorization. The measured figure is an average of 5.1 months from filing to a definitive INVIMA concept, approving or rejecting, against a stable volume of roughly 90 protocol-evaluation requests a year. Sponsors should plan the ethics-committee approval, the INVIMA concept and the import authorization as sequential rather than parallel steps. The clinical-research bill filed in August 2025 would replace the current position with tacit approval — 7 calendar days for common-risk and 30 for high-risk studies — but it is not law.

    Does Colombia require post-trial access?
    No. Colombia does not currently mandate post-trial access by statute. Resolución 2378 de 2008 and Resolución 8430 de 1993 contain no post-trial supply obligation; Resolución 8430 allocates only harm-related costs. bioaccess® can operate voluntary continuity programs in Colombia on sponsor request, governed by the protocol, the informed consent and the ethics committee’s expectations rather than by statute. Statutory PTA mandates in Latin America currently apply to Argentina, Brazil, Panama, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras and Nicaragua.

    What is INVIMA Registro Sanitario?
    Registro Sanitario is the INVIMA authorization required to market a medical device in Colombia, granted under Decreto 4725 de 2005 following technical evaluation under Article 18 and legal evaluation under Article 19. INVIMA may issue one request for additional or clarifying information, and the applicant has 90 days to respond before the file is deemed abandoned. Manufacturing and storage certificates — BPM and CCAA — are valid for five years. For class IIb and III devices, Article 18(k) requires clinical studies demonstrating safety and effectiveness, which is why trial design and registration strategy belong in the same plan.

    Which Colombian cities have the best clinical-trial infrastructure?
    Bogotá, Medellín and Cali are the tier-1 clusters, and INVIMA’s own register of approved ethics committees places committees in those three cities plus Floridablanca and Montería, attached to established IPS and medical foundations. More than 160 centres held INVIMA Good Clinical Practice certification as of December 2024. The practical selection criterion is not city size but whether the certified institution holds authorized pharmaceutical service, clinical laboratory and sample-collection services inside the same habilitación, because a contracted service adds documentation to every BPC modification.

    How does Colombia compare to Argentina, Panama and Chile for early-phase device trials?
    On published regulatory clocks, three of the four disclose nothing binding. Argentina’s Disposición 7516/2025 Article 5 assigns protocol evaluation to ANMAT’s Dirección de Investigación Clínica without stating a day-count. Panama’s Decreto Ejecutivo 21 of 23 April 2026 regulates Títulos III and IV of Ley 84 de 2019 with no authorization day-count on the MINSA page. Chile’s ISP publishes 45 business days for the resolution authorizing import of unregistered pharmaceutical products for trial use. Colombia publishes no clock but has a measured 5.1-month average and, unlike the other three, publishes both its approvals and its refusals for device studies.

    What has changed at INVIMA since 2022?
    Resolución 2022035262 of 20 September 2022 created the GICASE group for device clinical research and support to the specialized chamber. The SEDMRDIV now carries an explicit mandate to evaluate device and IVD research protocols. INVIMA publishes registers of approved device studies, non-approved device studies with reasons, SEDMRDIV import authorizations for observational studies, and ethics-committee and site inspection status to November 2025. Its public study search reported 1,157 studies with a data date of 12 August 2026. INVIMA also remains one of eight PAHO Level IV Regional Reference Regulatory Authorities.

    Sources

    • INVIMA — Cooperación internacional (PAHO Level IV ARNr status): https://www.invima.gov.co/el-instituto/cooperacion-internacional
    • PAHO/OPS — Autoridades Regulatorias de Referencia: https://www.paho.org/es/autoridades-regulatorias-referencia
    • INVIMA — Investigación Clínica, Dispositivos (GICASE, Resolución 2022035262 de 2022, forms ASS-RSA-FM085/169/170/171/172, published registers): https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/investigacion-clinica
    • INVIMA — Sala especializada de dispositivos médicos y reactivos de diagnóstico in vitro: https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/sala-especializada-dispositivos-reactivos
    • INVIMA — Registro de estudios clínicos con dispositivos médicos no aprobados 2021–2025: https://www.invima.gov.co/biblioteca/registro-estudios-clinicos-dispositivos-medicos-no-aprobados-invima-2021-2025
    • INVIMA — Lista de Estudios Clínicos (public study search, data date 12 August 2026): https://www.invima.gov.co/estudios
    • INVIMA — Fiscalización de Ensayos Clínicos, Medicamentos (Protocolos en Línea, tariffs 4070/4083, Resolución 2011020764 de 2011): https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologicos/medicamentos-de-sintesis-quimica-y-biologica/ensayos-clinicos
    • INVIMA — Procesos de certificación en Buenas Prácticas Clínicas (BPC certificate, 5-year validity): https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologicos/medicamentos-de-sintesis-quimica-y-biologica/licenciamiento-auditorias-y-certificaciones/certificaciones-en-buenas-practicas
    • INVIMA — Listado de Comités de Ética en Investigación aprobados a mayo 2025: https://www.invima.gov.co/biblioteca/comites-etica-investigacion-aprobados-invima-2025
    • Decreto 4725 de 2005 (Arts. 2, 18, 19, 21, 22, 36, 48, 89) — Función Pública, Gestor Normativo: https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=18697
    • Decreto 677 de 1995 (Art. 96 exceptional import; Arts. 145–146) — INVIMA normograma: https://normograma.invima.gov.co/compilacion/docs/decreto_0677_1995.htm
    • Resolución 2378 de 2008 (Buenas Prácticas Clínicas) — Instituto Nacional de Salud: https://www.ins.gov.co/Normatividad/Resoluciones/RESOLUCION%202378%20DE%202008.pdf
    • Resolución 8430 de 1993 — MinSalud: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/de/dij/resolucion-8430-DE-1993.PDF
    • Resolución INVIMA 2025046281 de 19 de septiembre de 2025 (contingency plan; Fondo Nacional de Estupefacientes prioritization): http://normograma.invima.gov.co/normograma/compilacion/docs/resolucion_invima_46281_2025.htm
    • Resolución INVIMA 2025010547 de 19 de marzo de 2025 (Plan de Contingencia): https://normograma.invima.gov.co/compilacion/docs/resolucion_invima_10547_2025.htm
    • DANE — Nota Técnica, Proyecciones de Población, July 2025 (53 million in 2025): https://www.dane.gov.co/files/censo2018/proyecciones-de-poblacion/Nacional/NotaTecnica-PPED-jul2025.pdf
    • Cámara de Representantes — clinical-research framework bill, August 2025 (tacit approval 7/30 days, ICH E6, ISO 14155:2020): https://hcrpruebas.camara.gov.co/wp-content/uploads/2025/08/proyectos_ley/25082025_25082025_ver_documento_17.pdf
    • ConsultorSalud, 25 June 2025 — INVIMA average 5.1 months to definitive concept; ~90 protocols/year; 160+ BPC-certified centres: https://consultorsalud.com/colombia-reto-regulacion-estudios-clinicos/
    • ConsultorSalud, June 2026 — draft unified medical device sanitary regime replacing Decretos 4725/2005 and 3770/2004: https://consultorsalud.com/regimen-unico-dispositivos-medicos-impactos/
    • ConsultorSalud, February 2026 — MinSalud draft resolution partially repealing Resolución 8430 de 1993: https://consultorsalud.com/minsalud-investigacion-salud-seres-humanos-ips/
    • Disposición ANMAT 7516/2025, Art. 5 — Boletín Oficial de la República Argentina: https://www.boletinoficial.gob.ar/detalleAviso/primera/332695/20251009
    • Instituto de Salud Pública de Chile — 45 business days for trial import authorization: https://www.ispch.gob.cl/pregunta-frecuente/p-141/
    • MINSA Panamá — Decreto Ejecutivo N° 21 de 23 de abril de 2026: https://www.minsa.gob.pa/normatividad/decreto-ejecutivo-ndeg-21-jueves-23-de-abril-2026-que-reglamenta-los-titulos-iii-y-iv
    • bioaccess® — Colombia clinical trial regulatory guide: https://bioaccessla.com/regulatory-guide/colombia

  • Post-trial access in Latin America: the operator’s map

    Ten Latin American countries legally require a trial sponsor to keep supplying the investigational product after the study closes. Three more address post-trial continuation in binding instruments with weak or unassigned duties. Seven impose nothing. If your Phase 3 has LATAM sites, that distinction is a line item, not an ethics footnote.

    We built this map because the region is now diverging fast. Brazil enacted a statute in 2024 and its regulation in 2025. Honduras went from zero to a mandate in February 2026. Panama replaced its research decree in April 2026. Meanwhile most global vendor and law-firm summaries still cite instruments that have been repealed, and several repeat citation errors that a regulator would catch on the first review cycle.

    Where the mandates actually are

    Across 20 jurisdictions, the classification breaks down as follows.

    Binding statutory mandate (10): Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua, Panama. Each has a law, decree, resolution or ministerial normativa that obliges continued provision of the investigational product after the trial ends.

    Binding instrument, weak or unassigned duty (3): Uruguay, Bolivia, Venezuela. Venezuela’s Buenas Prácticas Clínicas §6.12.1 requires the sponsor only to “procurar… la provisión del tratamiento” after the trial — endeavour, not provide (INHRR). Uruguay’s Decreto 158/019 Anexo numeral 24 says participants “deben tener la certeza de que contarán con los beneficios demostrados” but names no obligor at all (IMPO). Bolivia’s Art. 99 routes continuation entirely into the compassionate-use chapter, requiring per-patient DINAMED authorization (AGEMED).

    No mandate (7): Mexico, Colombia, Paraguay, El Salvador, Dominican Republic, Cuba, Puerto Rico. In each case we read the operative clinical-trial instrument and it contains no post-trial supply obligation.

    The comparative matrix

    Country Mandate status Primary instrument Cost allocation Import mechanism
    Argentina Binding statute Disp. ANMAT 12792/2016; GCP base reset by Disp. 7516/2025 Sponsor, free to participant, site and payer (Art. 3(g)) Dedicated PTA import expediente to ANMAT–DERM, valid 12 months (Art. 4); physical import via INAME (Art. 5)
    Brazil Binding statute Lei 14.874/2024 Arts. 30–37 + Decreto 12.651/2025 Art. 31 Sponsor (Lei Art. 31 §4); free supply (Decreto Art. 31) ANVISA authorization + import licence under RDC 38/2013
    Chile Binding statute Ley 20.850 Art. 17; Cód. Sanitario Art. 111 C “Sin costo para el paciente”; duty on provisional-authorization holder, then registration holder ISP special provisional-use authorization (Art. 111 A); CENABAST exceptional import
    Peru Binding statute DS 021-2017-SA Arts. 115–118 Sponsor-funded, provided free (Arts. 40(p), 89) OGITT extension trial or case-by-case ANM/DIGEMID authorization (Art. 116) with a seven-document set (Art. 117)
    Panama Binding statute Decreto Ejecutivo 21/2026 Art. 68, Gaceta Oficial 30510-C, 23 Apr 2026 Investigators and sponsors co-obligated to ensure access; cost not stated verbatim Extension of the trial import permit for exclusive participant use (Art. 68); RESEGIS registration + DNFD authorization (Art. 99)
    Ecuador Binding statute AM 00069-2024 Arts. 80–81, 95(c) Sponsor or legal representative, “entrega gratuita” (Art. 80) No PTA-specific route; general ARCSA import authorization
    Costa Rica Binding statute Ley 9234 Arts. 28, 53(k) Sponsor, free, “mientras lo requieran” None identified in the statute for post-trial product
    Guatemala Binding statute (instrument version unconfirmed) AM 82-2019 Art. 64; MSPAS index lists AM 206-2021 Supply “podrá ser solicitada al patrocinador” — request-driven, not automatic Compassionate-use authorization by the DRCPFA (Art. 65)
    Honduras Binding statute (new) Acuerdo 0256-ARSA-2025 Art. 63 Sponsor or legal representative, “sin costo” (Art. 63) Extension trial or compassionate use (Art. 63); special ARSA import authorization (Art. 86)
    Nicaragua Binding statute Normativa-166 Cap. VI num. 16 Sponsor obliged; free-of-charge stated for the trial phase only General trial import rules; no PTA route
    Uruguay Binding guidance Decreto 158/019 Anexo num. 24 No obligor named n.a.
    Bolivia Binding guidance Norma para Estudios Clínicos Art. 99 → Arts. 74–76 Not allocated post-trial Per-patient DINAMED compassionate-use authorization
    Venezuela Binding guidance Normas de BPC §§5.4.5, 6.12.1 Free during trial only; post-trial duty is “procurar” None described
    Mexico No mandate for product supply NOM-012-SSA3-2012 §11.2.2 Investigator must arrange continued “tratamiento y cuidados” — not IP supply n.a.
    Colombia No mandate Res. 2378/2008 n.a. n.a.
    Paraguay No mandate Resol. DINAVISA 238/2024 n.a. n.a.
    El Salvador No mandate Lineamientos Técnicos, Ac. Ejec. 1530 (2025) n.a. n.a.
    Dominican Republic No mandate Manual CONABIOS, 2ª ed. n.a. — §7.1 gives an information right only n.a.
    Cuba No mandate BPC en Cuba (CECMED) n.a. — §4.3.2 covers adverse-event medical care only n.a.
    Puerto Rico (US) No mandate 21 CFR 312 Subpart I n.a. — permissive expanded-access framework n.a. (US customs territory)

    Why this is a closing cost, not an ethics footnote

    A sponsor that runs sites in Brazil, Chile, Peru, Panama and Argentina and then closes the study has, in five jurisdictions, a legally enforceable duty to keep shipping product to responders — free of charge, under separate authorizations, for a period the sponsor does not control.

    Brazil’s Ministry of Health states the position without hedging: continued post-study treatment “não é uma expectativa, mas um dever legal, aplicável desde o planejamento da pesquisa até o período pós-estudo” (INAEP FAQ). That duty is priced nowhere in a standard Phase 3 budget. It requires a cohort-scale filing distinct from the trial dossier, an import authorization with its own clock, GDP-compliant cold chain for as long as the cohort persists, and pharmacovigilance reporting after database lock.

    The obligation also survives corporate events. Chile’s Código Sanitario Art. 111 C states the duty “afectará al titular del registro sanitario, aun cuando no haya sido el titular de la autorización provisional o haya adquirido con posterioridad el registro sanitario” (BCN). Buy a Chilean registration and you buy the free-supply obligation attached to it. That belongs in diligence, not in a site-activation checklist.

    The five strongest sponsor obligations

    Brazil. Lei 14.874/2024 Art. 30 requires the sponsor and investigator to file a post-study access plan with the CEP before the trial starts. Art. 31 §4 puts the cost on the sponsor. Art. 33 permits interruption only on listed grounds, including the “transcurso do prazo de 5 (cinco) anos, contado da disponibilidade comercial do medicamento experimental no País.” Decreto 12.651/2025 Art. 31 restates the free-supply duty whenever the investigator judges the product the best therapeutic alternative. Full detail in our Brazil post-trial access pillar.

    Chile. Art. 111 C obliges continuity “sin costo para el paciente… por todo el tiempo que persista su utilidad terapéutica” — no commercialization endpoint, no five-year cap. See the Chile Ley 20.850 analysis.

    Panama. Article 68 of Decreto Ejecutivo 21/2026 (Gaceta Oficial 30510-C, 23 April 2026) reads: “Los investigadores y patrocinadores deben asegurar a todos los participantes el acceso al producto, siempre que se haya comprobado el beneficio clínico o de salud pública de la intervención durante el estudio; hasta su comercialización en el país.” It then requires the sponsor to apply for “una extensión del permiso de importación del producto utilizado durante la investigación para uso exclusivo de los participantes.” The decree entered into force on promulgation under Art. 105. Detail in the Panama Decreto 21/2026 pillar.

    Argentina. Disposición ANMAT 12792/2016 is the only instrument in the region that is purely a post-trial access import procedure. Art. 3(g) requires a sworn sponsor declaration that supply will be “sin costo alguno para el participante, el establecimiento asistencial o su cobertura de salud” — note that the site and the payer are named, not just the patient. Art. 4 gives the DERM authorization a 12-month validity. Art. 2 excludes authorized extension studies, which run on a different track. See the Argentina Disposición 12792 pillar.

    Peru. DS 021-2017-SA is the best-drafted operational regime in the region: Art. 115 defines the obligation and its trigger conditions, Art. 116 names two authorization routes (OGITT extension trial or case-by-case ANM/DIGEMID authorization), Art. 117 lists the documents, Art. 118 assigns post-access pharmacovigilance. Art. 40(p) makes it a sponsor duty. See the Peru DS 021-2017-SA pillar.

    Where the duty reaches devices

    Most LATAM post-trial provisions were drafted for medicines. Four jurisdictions reach hardware textually.

    Costa Rica is the clearest. Ley 9234 Art. 53(k) obliges the sponsor to provide, free of charge and after the study concludes, “el medicamento, dispositivo o procedimiento que ha sido objeto de investigación,” with four exhaustive exits — including a reasoned treating-physician resolution filed in the record and communicated to the CEC within three working days. Art. 28 sets the duration at “mientras lo requieran.”

    Brazil reaches devices through Lei 14.874/2024 Art. 37: “Aplicar-se-ão aos produtos e dispositivos médicos e aos produtos de terapias avançadas experimentais… as disposições deste Capítulo, no que couber.” Chile reaches them through Código Sanitario Art. 111 A, which covers “los productos farmacéuticos y los elementos de uso médico.” Peru reaches them through the definition of producto en investigación in Art. 2.1.36.

    Ecuador does not. AM 00069-2024 is a reglamento for medicines and processed natural medicinal products, so a device sponsor’s Ecuadorian exposure runs through ethics-committee expectations and the informed consent, not through Arts. 80–81.

    What changed between 2024 and 2026

    Honduras added a mandate. Acuerdo 0256-ARSA-2025 Art. 63 defines post-trial access as “la entrega sin costo por parte del patrocinador o su representante legal,” even where the product has no Honduran sanitary registration, subject to three cumulative conditions. Published in La Gaceta on 28 January 2026, in force 30 days later. The predecessor Acuerdo 041-2020 had no post-trial provision at all. Read Art. 63 alongside Art. 18 numeral 5, which softens the duty to facilitating access “cuando el patrocinador lo considere” — a real internal tension, and a reason not to treat Honduras as equivalent to Brazil.

    Panama replaced its research decree. Decreto Ejecutivo 21/2026 reglamenta Titles III and IV of Ley 84 de 14 de mayo de 2019 and entered into force on promulgation, 23 April 2026. Its Art. 104 repeals Decreto Ejecutivo 1843 of 2014, Decreto Ejecutivo 6 of 2015 and Resolución 390 of 2003.

    Ecuador deleted its endpoint. AM 00069-2024 Art. 80 states the free-supply duty with no termination point. The repealed AM 0075-2017 had capped it: Art. 39(w) ran only “hasta que el producto se comercialice en el país” (MSP Ecuador). Art. 81 narrowed the trigger to three cumulative conditions while the duration became open-ended. Almost nobody has flagged that trade.

    Brazil completed a two-step build. Statute in 2024, regulation in 2025, with further INAEP guidance promised by Decreto 12.651/2025 Art. 31 §2.

    Argentina reset its GCP base. Disposición 7516/2025 took effect 1 December 2025 (Art. 8). Its Art. 7 repealed Disposiciones 6677/10, 4008/17, 9929/19 and 2172/25 plus Circulares 0001/11 and 004/18. Disp. 12792/2016 is absent from that repeal list, so the post-trial import procedure stands — but the substantive continuity duty moved into the new GCP annex, and sponsors are filing against instruments that no longer exist. The legal architecture of LATAM PTA piece works through how the obligation layer and the import layer interact.

    Colombia: no binding post-trial access statute

    We read Resolución 2378 de 2008 and Resolución 8430 de 1993 in full, checking expressly for post-trial supply language. Neither contains any. Res. 8430/1993 allocates only harm-related costs — Art. 13 medical care for research-related injury, Art. 15(j) treatment availability and indemnification, Art. 15(k) additional costs against the research budget.

    That makes Colombia a cost-certainty jurisdiction: no statutory tail obligation, no separate post-trial filing, no open-ended supply exposure. It does not make post-trial access impossible. A sponsor that wants to continue supplying responders in Colombia can run a voluntary continuity program on its own initiative, handled through the ethics committee, the informed consent and the general product import rules. The exposure is contractual and reputational rather than statutory, which means it has to be allocated in the CRO and site agreements rather than assumed away.

    Mexico sits in an adjacent position and is routinely misdescribed. NOM-012-SSA3-2012 §11.2.2 obliges “el investigador principal” to arrange continuation of “el tratamiento y cuidados” to prevent withdrawal effects. That is an investigator duty about care, not a sponsor duty to supply the investigational product.

    What sponsors get wrong

    Citing repealed instruments. Argentina’s Disp. 6677/2010, which historically carried the continuity obligation, is repealed. Ecuador’s AM 0075-2017 is repealed. Honduras’s Acuerdo 041-2020 is revoked in its entirety. Panama’s Decreto Ejecutivo 1843/2014 and 6/2015 are repealed. Filings and legal memos still quote all of them.

    The “Ley 419/2023” error. Panama’s medicines statute is Ley 419 of 1 February 2024, not 2023 — and it is a commercial-medicines law, not the post-trial access instrument. The binding post-trial duty sits in Decreto Ejecutivo 21/2026 Art. 68, under Ley 84 of 2019. Getting this wrong signals to a Panamanian reviewer that the filer has not read the current framework.

    Treating Argentina’s RAEM as post-trial access. Disposición 4616/2019 approves the Régimen de Accesibilidad de Excepción a Medicamentos: an individual-patient exceptional import route with 90-day, 180-day and one-year quantity windows (Boletín Oficial). It contains no reference to clinical trials or post-trial access. Filing a trial cohort through RAEM means one expediente per patient, per renewal, on the wrong legal basis. Cohort post-trial access in Argentina runs on Disp. 12792/2016.

    Assuming an obligation implies a pathway. Costa Rica mandates continued free provision of the device or medicine under Art. 53(k), but Art. 55 addresses importation only before an approved study begins. No post-trial import route is identified in the statute. Ecuador and Nicaragua have the same shape. The obligation is real; the mechanism has to be constructed.

    The fastest route to compliance

    For a sponsor closing a multi-country LATAM Phase 3, the sequence that works is: classify each participating country into mandate / soft / none using the operative current instrument; identify which mandate countries require a filing distinct from the trial dossier (Argentina, Brazil, Panama, Peru at minimum); confirm whether your product class is textually in scope, which matters most for devices; establish who the legal importer of record will be in each country, since the trial import authorization frequently expires with the trial; and only then estimate cohort size, duration and cold-chain cost. Countries with no mandate still need a documented position, because the ethics committee and the informed consent will ask.

    Working on a LATAM post-trial access program? bioaccess® is a US-headquartered, LATAM-native operator running regulatory, importadora, and 2–8 °C GDP cold-chain functions directly across the region. If you’re evaluating PTA feasibility in Argentina, Brazil, Chile, Peru, Panama, Costa Rica or elsewhere in Latin America, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently Asked Questions

    Which Latin American countries require post-trial access?
    Ten jurisdictions impose a binding statutory duty: Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua and Panama. Three more — Uruguay, Bolivia and Venezuela — address post-trial continuation in binding instruments but with weak verbs, no named obligor, or routing into per-patient compassionate use. Seven impose nothing: Mexico, Colombia, Paraguay, El Salvador, the Dominican Republic, Cuba and Puerto Rico. The classification depends on reading the operative current instrument, not a secondary summary, because five of these countries changed their framework between 2024 and 2026.

    Which LATAM country has the strongest post-trial access mandate?
    Brazil. Lei 14.874/2024 Art. 30 requires a post-study access plan to be filed with the ethics committee before the trial begins, Art. 31 §4 assigns the cost to the sponsor, and Art. 33 permits interruption only on listed grounds — one of which is the passage of five years from the product’s commercial availability in Brazil. Decreto 12.651/2025 Art. 31 restates the free-supply duty. Brazil’s Ministry of Health describes this as a legal duty rather than an expectation. Chile is the closest runner-up because Art. 111 C has no endpoint at all and the obligation follows the sanitary registration to any subsequent holder.

    Does post-trial access in LATAM apply to medical devices or only drugs?
    Both, in four jurisdictions. Costa Rica’s Ley 9234 Art. 53(k) is the most explicit, obliging free post-study provision of “el medicamento, dispositivo o procedimiento.” Brazil extends its post-trial chapter to devices and advanced therapies through Lei 14.874/2024 Art. 37. Chile’s Código Sanitario Art. 111 A covers “elementos de uso médico.” Peru’s definition of producto en investigación in DS 021-2017-SA Art. 2.1.36 includes devices. Ecuador’s AM 00069-2024 does not cover devices. Argentina’s Disp. 12792/2016 covers products and “materiales” without using the word dispositivo médico, so device coverage there is inferential.

    Which LATAM countries do NOT require post-trial access?
    Mexico, Colombia, Paraguay, El Salvador, the Dominican Republic, Cuba and Puerto Rico. Colombia’s Resoluciones 2378/2008 and 8430/1993 contain no post-trial supply obligation; Res. 8430/1993 allocates only harm-related costs. Mexico’s NOM-012-SSA3-2012 §11.2.2 imposes a continuity duty on the principal investigator covering treatment and care, not on the sponsor to supply the investigational product. Notably, both Paraguay (2024) and El Salvador (2025) rewrote their research frameworks in this window and declined to add a post-trial provision, which cuts against the assumption that the whole region is converging on mandatory access.

    What changed in LATAM post-trial access regulation in 2024-2026?
    Five substantive moves. Brazil completed a two-step build with Lei 14.874/2024 and Decreto 12.651/2025. Ecuador’s AM 00069-2024 repealed AM 0075-2017 and deleted the “until commercialized in the country” endpoint, converting a bounded duty into an open-ended one. Argentina’s Disposición 7516/2025 took effect 1 December 2025 and repealed Disp. 6677/10 among others, resetting the GCP base while leaving the 2016 post-trial import procedure standing. Honduras moved from no mandate to a binding mandate via Acuerdo 0256-ARSA-2025 Art. 63, in force from late February 2026. Panama’s Decreto Ejecutivo 21/2026 entered into force 23 April 2026 with a binding post-trial duty in Art. 68.

    What is the difference between cohort PTA (Argentina) and individual expanded access (RAEM)?
    They are separate legal regimes with separate instruments. Post-trial access under Disposición ANMAT 12792/2016 is a cohort-level procedure: one expediente covering the named participants from an ANMAT-authorized trial, approved by the ethics committee, filed with the Dirección de Evaluación y Registro de Medicamentos, with a 12-month import authorization under Art. 4. The Régimen de Accesibilidad de Excepción a Medicamentos under Disposición 4616/2019 is an individual-patient exceptional import route with 90-day, 180-day and one-year quantity limits, and it makes no reference to clinical trials. Using RAEM for a trial cohort produces per-patient filings on the wrong basis.

    Who pays for post-trial access in Latin America?
    The sponsor, in every country where the duty is clearly allocated. Brazil’s Lei 14.874/2024 Art. 31 §4 puts the supply on the sponsor. Peru’s DS 021-2017-SA Art. 89 requires products to be sponsor-financed and provided free. Costa Rica’s Ley 9234 Art. 53(k) and Ecuador’s AM 00069-2024 Art. 80 both name the sponsor. Chile’s Art. 111 C places the duty on the provisional-authorization holder and then the registration holder. Argentina goes furthest: Disp. 12792/2016 Art. 3(g) requires a sworn declaration that supply carries no cost to the participant, the treating institution or the health coverage. Uruguay, Bolivia, Nicaragua and Honduras leave the cost-bearer partly or wholly unstated.

    How does a sponsor find a qualified PTA operator in Latin America?
    Test three capabilities separately. First, regulatory: can the operator file the country-specific post-trial authorization itself, naming the correct current instrument and article, rather than subcontracting it blind. Second, importation: can it act as legal importer of record after the trial import authorization lapses, which it does in several countries. Third, distribution: can it hold and ship the product under 2–8 °C GDP conditions for the life of the cohort, with pharmacovigilance reporting after database lock. Global post-trial supply vendors market the service regionally without naming Latin American countries or local filing capability on their public pages, so ask for the specific article and the specific authorizing office.

    What is the fastest route to compliance for a sponsor closing a multi-country LATAM Phase 3?
    Start from the operative instrument in each participating country, not from a regional summary. Classify each country as binding mandate, weak instrument or no mandate; determine which mandate countries require a filing distinct from the trial dossier — Argentina, Brazil, Panama and Peru at minimum; confirm your product class is textually in scope, which is the decisive question for devices; appoint a legal importer of record in each country because trial import authorizations frequently expire with the trial; then size the cohort, the duration and the cold chain. Countries with no mandate still need a documented, defensible position for the ethics committee.

    Sources

    • Argentina — Disposición ANMAT 12792/2016: https://www.boletinoficial.gob.ar/detalleAviso/primera/154162/20161117
    • Argentina — Disposición ANMAT 7516/2025: https://www.boletinoficial.gob.ar/detalleAviso/primera/332695/20251009
    • Argentina — Disposición ANMAT 4616/2019 (RAEM): https://www.boletinoficial.gob.ar/detalleAviso/primera/208794/20190604
    • Brazil — Lei nº 14.874/2024: https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm
    • Brazil — Decreto nº 12.651/2025: https://www2.camara.leg.br/legin/fed/decret/2025/decreto-12651-7-outubro-2025-798105-publicacaooriginal-176652-pe.html
    • Brazil — ANVISA RDC nº 38/2013: https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000038&seqAto=000&valorAno=2013&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true
    • Brazil — Ministério da Saúde / INAEP FAQ on acesso pós-estudo: https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/faq/faq/acesso-pos-estudo/o-acesso-fornecimento-pos-estudo-e
    • Chile — Ley 20.850 and Código Sanitario Arts. 111 A–111 C: https://www.bcn.cl/leychile/navegar?idNorma=1078148
    • Peru — Reglamento de Ensayos Clínicos, DS 021-2017-SA: https://ensayosclinicos-repec.ins.gob.pe/images/Reglamento_de_EC.pdf
    • Panama — Decreto Ejecutivo No. 21 de 23 de abril de 2026, Gaceta Oficial Digital No. 30510-C (Arts. 68, 99, 104, 105); primary text read from the Gaceta Oficial PDF
    • Panama — Ley 419 de 1 de febrero de 2024 (medicamentos): https://www.minsa.gob.pa/sites/default/files/normatividad/ley-419-de-2024-ley-de-medicamentos.pdf
    • Ecuador — Acuerdo Ministerial 00069-2024: https://www.espoch.edu.ec/wp-content/uploads/2025/10/ac-00069-2024_dic_31_compressed_1-1.pdf
    • Ecuador — Acuerdo Ministerial 0075-2017 (repealed): https://www.salud.gob.ec/wp-content/uploads/2022/09/A.M.-0075-REGLAMENTO-ENSAYOS-CLINICOS-1.pdf
    • Costa Rica — Ley N.º 9234, Ley Reguladora de Investigación Biomédica: https://documentos.una.ac.cr/bitstream/handle/unadocs/5670/Texto%20Completo%20Norma%209234.pdf?sequence=1&isAllowed=y
    • Guatemala — Acuerdo Ministerial 82-2019: https://medicamentos.mspas.gob.gt/phocadownload/Acuerdo%20Ministerial%2082-2019.pdf
    • Guatemala — MSPAS legislación vigente index (AM 206-2021): https://medicamentos.mspas.gob.gt/index.php/legislacion-vigente/acuerdos
    • Honduras — Acuerdo No. 0256-ARSA-2025: https://www.tsc.gob.hn/web/leyes/Acuerdo-0256-ARSA-2025.pdf
    • Nicaragua — Normativa-166, Norma para la Regulación de Ensayos Clínicos: https://www.minsa.gob.ni/sites/default/files/2022-10/Norma%20de%20Ensayos%20Clinicos.11833.pdf
    • Uruguay — Decreto N° 158/019, Anexo: https://www.impo.com.uy/bases/decretos-originales/158-2019/8
    • Bolivia — Norma para Estudios Clínicos (AGEMED): https://www.agemed.gob.bo/archivos_agemed/ensayosclinicos/001-2021.pdf
    • Venezuela — Normas de Buena Práctica Clínica (INHRR): https://inhrr.gob.ve/pdf/pdf_jr/JR-1311-2013.pdf
    • Mexico — NOM-012-SSA3-2012: https://sidof.segob.gob.mx/notas/docFuente/5284148
    • Colombia — Resolución 2378 de 2008: https://www.ins.gov.co/Normatividad/Resoluciones/RESOLUCION%202378%20DE%202008.pdf
    • Colombia — Resolución 8430 de 1993: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/de/dij/resolucion-8430-DE-1993.PDF
    • Paraguay — Resolución DINAVISA 238/2024: https://dinavisa.gov.py/wp-content/uploads/2024/10/2.-Requisitos-de-Ensayos-Clinicos.-Resol.-238_2024.pdf
    • El Salvador — Lineamientos Técnicos para la Investigación en Salud, Acuerdo Ejecutivo 1530 (2025): https://asp.salud.gob.sv/regulacion/pdf/lineamientos/lineamientostecnicosparalainvestigacionensalud-Acuerdo-Ejecutivo-1530-29052025_v1.pdf
    • Dominican Republic — Manual de Normas y Procedimientos Operativos, CONABIOS: https://conabios.gob.do/wp-content/uploads/2025/02/1.Manual-de-Normas-y-Procedimientos-Operativos-V2-13-02.pdf
    • Cuba — Buenas Prácticas Clínicas en Cuba (CECMED): https://www.cecmed.cu/sites/default/files/adjuntos/Reglamentacion/Dir_BPC.pdf
    • United States / Puerto Rico — 21 CFR 312.310 (Expanded Access, Subpart I): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-I/section-312.310
    • FDA — Expanded Access training materials: https://www.fda.gov/media/193381/download

  • Argentina And Colombia Just Signed A Regulatory Mou. Here’s What That Means For Medtech Sponsors Running Multi-Country LATAM Trials.

    The Headline

    On June 13, 2026, Argentina’s ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and Colombia’s INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) signed a Memorandum of Understanding that formalizes bilateral cooperation across medicines, food, and medical devices. The text was published on the INVIMA portal the same day. [INVIMA]

    For sponsors running, planning, or sequencing multi-country clinical programs in Latin America, this matters more than the typical regulatory press release. It is the most operationally consequential change to the Argentina-Colombia regulatory interface since 2018 — and it lands at the exact moment Colombia is finalizing its Decreto Único de Dispositivos Médicos and Argentina is operationalizing ICH E6(R3) Annex 2.

    This article walks through what the MoU actually establishes, what it does not establish, and how MedTech and Biopharma sponsors should sequence their LATAM trials in light of it.

    What The MoU Actually Says

    The June 13 instrument is short on legal flourish and dense on operational substance. Stripped to its four working pillars, the MoU establishes:

    1. Information exchange across regulated categories — covering registration dossiers, surveillance signals, and inspection findings.
    2. Protocol and best-practices sharing — methodologies, technical guidance, and procedural alignment on common review pathways.
    3. Joint project collaboration — coordinated capacity-building initiatives, training exchanges, and technical mission programming.
    4. Confidentiality and monitoring framework — formal governance of how shared data is handled and how cooperative activities are tracked over time.

    The cooperation explicitly covers medicines, food, and medical devices. That last category is the one many sponsors miss. The 2014 and 2018 instruments between the two agencies were narrower — 2014 focused on “exchange of experiences and good practices,” and 2018 was specifically about Good Manufacturing Practice inspection records. The 2026 MoU is the first comprehensive framework that unifies the medical device dimension with pharmaceuticals and food under a single working architecture. [ANMAT Cooperation Registry]

    What The MoU Does Not Do

    Three clarifications worth front-loading, because we are already seeing them misunderstood in early secondary commentary.

    The MoU does not create single-window approvals. A sponsor preparing a clinical trial in both Argentina and Colombia still files two separate dossiers, with two separate regulatory teams, on two distinct timelines. ANMAT continues to operate Disposición 7516/25 and the Resolution 1480/2011 ethics framework. INVIMA continues to operate under Decreto 4725 de 2005 and Resolución 1229 de 2013 until the new Decreto Único is published.

    The MoU does not formalize automatic reliance. Reliance — where one regulator can lean on another’s scientific assessment to shorten its own review — exists as a regulatory principle in both agencies’ modernization agendas, but the MoU itself does not create a reliance pathway between them. It creates the plumbing through which such pathways can later be built.

    The MoU does not change cost or fee structures. Sponsors should not expect this instrument to reduce regulatory review fees, ethics committee charges, or local sponsor representation costs in either jurisdiction.

    What It Does, In Practice

    What the MoU does, immediately, is formalize four operational improvements that previously depended on ad-hoc coordination through ICH Assembly hallway conversations and the International Pharmaceutical Regulators Programme (IPRP) plenary sessions.

    One. When a sponsor’s submission triggers a safety signal in one country, that signal can now flow through a structured channel to the other regulator within a defined confidentiality envelope. Before this MoU, a sponsor with a flagged adverse event in Argentina would typically receive an independent inquiry from Colombia weeks or months later, often duplicating the original investigation. After this MoU, the two regulators can coordinate the inquiry’s timing and scope.

    Two. Inspection of a sponsor or manufacturer operating in both jurisdictions can be coordinated. A single inspection mission, with two regulators present or with shared inspection reporting, materially compresses the sponsor’s compliance overhead.

    Three. Capacity-building and training activities — pharmacovigilance, tecnovigilancia, quality risk management — can be conducted jointly. This raises the technical floor in both countries, which is good for sponsors because the predictable downside of trial expansion to a smaller-budget regulator is technical inconsistency at the review level.

    Four. Standards and review methodologies can be aligned over time. The MoU does not specify which standards or methodologies, but it creates the working group structure to negotiate them. The most likely early candidates are software-as-a-medical-device classification, AI/ML model change pathways, and harmonization of IMDRF-aligned UDI requirements.

    The Decreto Único Context

    The MoU lands during one of the most active periods of Colombian medical device regulatory reform in two decades. Colombia’s Decreto Único de Dispositivos Médicos — a 16-chapter, 180-article instrument that consolidates and replaces Decretos 4725/2005 and 3770/2004 — completed its national public consultation phase and entered WTO international consultation on May 18, 2026. The comment window closes July 17, 2026. [CONSULTORSALUD]

    INVIMA’s Director of Medical Devices and Other Technologies, Doris Yolima Gómez Parada, has been publicly explicit about the substantive direction: indefinite-validity authorizations (conditioned on post-market performance), strengthened tecnovigilancia, mandatory Unique Device Identification (UDI) at initial registration, IMDRF-aligned risk classification (three classes expanding to four), and an explicit reliance framework that recognizes FDA, EMA, and ANVISA assessments — supplemented by Pacific Alliance, Rio Accord, and WHO Listed Authority qualifications.

    For a multi-country sponsor, the implication is direct: the Decreto Único modernizes Colombia’s regulatory architecture in ways that are structurally compatible with Argentina’s ICH E6(R3) Annex 2 adoption. The June 13 MoU is the procedural connective tissue between the two modernizations.

    The Argentina Side: ICH Annex 2 Operative

    Argentina entered this MoU from a position of unusual regulatory strength. ANMAT adopted the ICH E6(R3) operative framework under Disposición 7516/25, and Annex 2 — the risk-proportionate quality management addendum — was finalized to Step 4 at the ICH Assembly in Rio de Janeiro on June 3, 2026, two weeks before the MoU was signed. ANMAT confirmed participation in both the ICH Assembly and the IPRP sessions of June 3-4.

    Argentina’s documented FIH timeline benchmark currently sits at 62 days from study start to first patient enrolled, inclusive of ethics committee review, ANMAT regulatory authorization, and clinical site activation. That benchmark assumes a well-prepared sponsor working with operational sites in greater Buenos Aires, La Plata, Mendoza, and Rosario.

    The MoU’s value to an Argentina-primary sponsor is that secondary expansion into Colombia — historically a separate operational track with limited information continuity — now sits on a coordinated information channel. The Decreto Único’s reliance pathway, once operational, can in principle leverage Argentina-generated dossier work for parts of the Colombian submission.

    Practical Implications: How To Sequence A Multi-Country Trial Now

    For a MedTech, Biopharma, or Radiopharma sponsor planning a 2026-2027 LATAM trial, the operational sequencing question changes in three ways.

    Argentina-primary sequencing is now operationally cleaner. If your indication has equivalent patient availability in both Argentina and Colombia, starting in Argentina has three compounding advantages: ICH E6(R3) Annex 2 inspection-readiness, a 62-day study start timeline, and — under the MoU — a smoother information bridge into Colombia for the secondary expansion.

    Colombia is no longer a second-tier choice for sponsors with cardiovascular, oncology, or rare-disease indications. The combination of the MoU plus the Decreto Único’s reliance framework plus Colombia’s IMDRF affiliate member status (effective September 2025) materially raises Colombia’s strategic value. The five-month Colombian FIH timeline that has been the benchmark for the past three years will compress meaningfully once the Decreto Único is in force.

    The IRB and ethics committee dimension matters more, not less. The MoU does not touch independent ethics committee review. Sponsors gain little if their Argentine site is approved in 62 days and the Colombian ethics committee for a comparable indication takes four months. Operational selection of ethics committees with proven turnaround for the relevant therapeutic area becomes a larger fraction of the timeline gap.

    What To Watch Between Now And September

    Four watch items will determine how much of the MoU’s potential operational value crystallizes in 2026.

    July 17: The WTO comment window on the Decreto Único closes. Industry comment density and the substance of the final text will shape whether reliance is operationally meaningful or a paper provision.

    Late Q3 2026: Implementing language for the MoU. The instrument as signed is a framework. Working-group structure, the first joint technical projects, and any joint training program will signal how seriously both agencies intend to execute on the framework.

    Q4 2026: Decreto Único publication. The 18-month transition period for industry begins on publication. Sponsors should plan for a 2027 implementation horizon for the new Colombian regime.

    2027 onward: First coordinated inspection. If ANMAT and INVIMA execute a coordinated inspection of a sponsor or manufacturer operating in both countries, that becomes the case study that defines the MoU’s operational reality.

    Why This Matters For Operating At Scale In LATAM

    We have been operating multi-country clinical programs in Latin America since 2010. Across 47 first-in-human studies for MedTech, Biopharma, and Radiopharma sponsors, the practical bottleneck in expanding from a single-country trial to a regional program has rarely been regulatory text. It has been the discontinuities between regulators — different document formats, divergent timing assumptions, ethics committees that interpret international guidance differently, and the absence of any structured channel for coordinating safety information when a study runs in parallel in two jurisdictions.

    The MoU is the first instrument in our operating memory that addresses those discontinuities directly. It does not eliminate them. It builds the architecture inside which they can be addressed deliberately, instead of through ad-hoc coordination at ICH meetings.

    For sponsors evaluating LATAM right now, the immediate practical advice is: do not wait. The MoU’s value compounds for sponsors who establish operational presence in both Argentina and Colombia before the implementing language is in place — because those sponsors will be the test cases that shape how the MoU actually works. By the time the framework is mature, the operational advantage will have moved downstream.

    The Bottom Line

    The Argentina-Colombia MoU of June 13, 2026, does not change clinical trial regulation in either country. It changes the operating architecture between them. For multi-country LATAM sponsors, that architecture is the part of the regulatory environment that has been hardest to manage, and it is the part that has been most resistant to structural improvement.

    If your 2026-2027 strategic plan included evaluating LATAM as a multi-country option for an FIH or early-feasibility study, the case just got materially stronger. If your plan did not include LATAM, the regulatory ceiling that previously made multi-country expansion operationally difficult has been formally lifted.

    The two LATAM regulators with the deepest reform agendas in the region just connected their working architecture. The sponsors who move first will define what the connection means.

    bioaccess® is a clinical research organization purpose-built for first-in-human and early-phase studies for MedTech, Biopharma, and Radiopharma startups in Latin America. We have supported 47 FIH programs since 2010 across Argentina, Brazil, Colombia, Mexico, Costa Rica, and Panama. To discuss a multi-country LATAM trial strategy, contact us at info@bioaccessla.com or visit bioaccessla.com/roadmap.