Do LATAM regulators require preclinical study reports to be translated into Spanish?

Not as a class. Across 19 Latin American countries and 50 primary-source instruments, no regulator or ethics committee writes a rule that specifically names a biocompatibility dossier, a toxicology report, an ISO 14971 file, a design V&V, a cleaning validation, or an IEC 60601 test report as a required translated deliverable. In 14 of 19 countries, the underlying preclinical reports are neither required as translated deliverables nor treated as reachable by any general translate-clause. In 5 of 19 countries — Brazil, Cuba, Ecuador, Nicaragua, and Paraguay's CEI-INS specifically — a general Spanish/Portuguese mandate combined with a preclinical filing item does reach those reports in principle.

What must be translated into Spanish for a LATAM clinical trial submission?

The closed list, consistent across the region, is: the protocol, the Investigator's Brochure body, the informed consent form, investigator CVs, product labels and instructions for use, and patient-facing materials. Colombia additionally requires a bilingual (Spanish and English) filing of the protocol and IB for drug studies. Sworn translation is limited to specific legal-status documents: Colombia's GMP certificate; Argentina 7516/2025's sponsor delegation-of-authority and foreign-authority approvals; Panama's ICF in indigenous-language contexts; WCG IRB's participant materials. Ecuador and Paraguay's CEI-INS are the two jurisdictions where a sworn/official-translation regime reaches beyond legal-status documents into the scientific dossier.

Does Argentina still exempt the Investigator's Brochure from the Spanish-language requirement?

Not by express clause. Disposición ANMAT 6677/2010 §2.4 did — its language was: “Todos los documentos… deben presentarse en idioma español, a excepción de la MPI dado que ésta sólo se utiliza como antecedente del estudio.” That disposition was derogated by Disp. 7516/2025 effective 1 December 2025. The successor's annexes contain no general language rule and no MPI carve-out. The MPI-in-English practice now survives as administrative discretion under Ley 20305 art. 6, not as an express regulatory allowance.

Does WCG IRB require preclinical reports to be translated?

No. WCG's translation regime attaches only to consent forms and participant materials, with a formal Certificate of Translation from the translator. The Investigator's Brochure is required “in most cases” with no translation obligation, and preclinical reports are not a WCG submission item at all.

Which LATAM countries require sworn/official translation that reaches the scientific dossier?

Two: Ecuador (ARCSA's Acuerdo Ministerial 0075-2017 art. 9 requires “traducción oficial, debidamente apostillada o legalizada” for all documentation, combined with the specific preclinical-report filing item at requirement 17) and Paraguay at the CEI-INS layer specifically (“traductor oficial” for all foreign-language documents, combined with the “estudios preclínicos disponibles” filing item). In the other 17 countries, sworn or certified translation attaches only to legal-status documents (GMP certificates, delegation instruments, foreign-authority approvals, ICFs in indigenous-language contexts), never to the scientific technical annex.

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What LATAM regulators actually require translated for preclinical documentation — a source-grounded look at 19 countries

What LATAM regulators and ethics committees actually require translated for the preclinical annex of clinical trial filings — 19 countries, 5 exceptions named.

By Julio G. Martinez-Clark · Published August 25, 2026 · 10 min read

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Scope of this article

Every claim here is scoped to clinical trial filings — protocols, Investigator's Brochures, informed consent forms, and the preclinical support annex submitted to a national regulator or ethics committee for authorization to conduct a study on human subjects. This article does not cover market clearance filings for commercial medical devices (INVIMA sanitary registration, COFEPRIS registro sanitario, ANMAT product registration, ANVISA RDC 751/2022 device registration, DIGEMID registro sanitario, ARCSA registro sanitario, CECMED registro sanitario). Those live in a separate submission universe with different language and sworn-translation rules. For a device-and-drug regulator sweep across nine countries, see our companion article on what nine LATAM regulators actually require for translating preclinical dossiers.

By Julio G. Martinez-Clark · Published August 25, 2026 · Last verified August 25, 2026 · Category: LATAM regulatory practice · 10 min read

The short answer

In 14 of 19 LATAM countries, no regulator and no ethics committee imposes a translation obligation on the underlying preclinical reports.
In 5 of 19 countries — Brazil, Cuba, Ecuador, Nicaragua, and Paraguay at the committee layer — a general translate-everything clause reaches those reports.
In 0 of 19 countries does any instrument specifically name a biocompatibility dossier, ISO 14971 file, toxicology report, design V&V, cleaning validation, or IEC 60601 test report as a required translated deliverable.

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The short version, before anyone reads further

We looked at every LATAM ethics committee with a public standard operating procedure we could retrieve, plus every national regulator across all 19 Latin American countries — 50 primary-source instruments in total — and asked one specific question:

*Does any regulator or ethics committee in LATAM require the underlying preclinical reports to be translated into Spanish or Portuguese? By “underlying preclinical reports” we mean the actual technical files: biocompatibility dossiers, GLP raw data, toxicology reports, ISO 14971 risk analyses, design verification and validation, cleaning and packaging validation, IEC 60601 or IEC 62304 test reports. We do not* mean the preclinical summary that lives inside the Investigator's Brochure body — that summary is expected in Spanish almost everywhere, and it is a legitimate translation requirement.

The answer, honestly stated:

In 14 of 19 LATAM countries, no regulator and no ethics committee we could find imposes a translation obligation on those underlying reports. Preclinical evidence is regulated as a Spanish summary inside the IB.
In 5 of 19 countries, a general “translate everything into Spanish or Portuguese” clause, combined with a preclinical filing item in the same instrument, reaches those reports in principle. Those countries are Brazil, Cuba, Ecuador, Nicaragua, and — at the committee layer only — Paraguay.
In 0 of 19 countries did any regulator or committee write a rule that specifically names a biocompatibility dossier, an ISO 14971 file, a toxicology report, a design V&V, a cleaning validation, or an IEC 60601 test report as a required translated deliverable.

Sponsors and CROs across the region have nevertheless been translating those documents for years. This article walks through what the regulators actually wrote — including where they wrote the opposite — and what a defensible translation scope looks like as a result.

The 5 countries where the general clause reaches preclinical reports — named openly

These are the exceptions. A defensible article names its counter-evidence before its supporting evidence.

Brazil

Brazil is a two-layer system. ANVISA, the medicines regulator, accepts a “free translation” backstop:

Quando necessária a tradução, na ausência de norma específica que exija tradução na versão juramentada, poderá ser aceita tradução livre.
— ANVISA RDC 947/2024

The clinical dossier can be filed in Portuguese, English, or Spanish (art. 11 §2). Contrary to a common misconception, ANVISA does not require sworn / juramentada translation of clinical-trial submission documents. Sworn translation in Brazil is a judicial-procedure and civil-registry standard (Código de Processo Civil art. 192; Código Civil art. 224; LINDB art. 15; CNJ Resolução 155). None of those rules reaches the ANVISA clinical dossier.

But no Brazilian trial reaches ANVISA without CEP/CONEP review, and here the picture flips:

Somente serão apreciados protocolos de pesquisa lançados na Plataforma e que apresentarem toda a documentação solicitada, em Português, acompanhado dos originais em língua estrangeira, quando houver.
— CONEP Norma Operacional 001/2013

Institutional CEPs restate the rule. UFSCar's mandatory-documents list is particularly explicit: it requires the Brochura do investigador or, in the alternative, “trabalhos que fundamentam a experimentação prévia” — the underlying works founding the prior experimentation — in Portuguese (UFSCar CEP). In Brazil, the general translate-clause reaches the preclinical annex at the ethics-committee layer even though the sanitary regulator's own rule would accept it in English or Spanish.

Cuba

CECMED, the Cuban regulator, combines a general Spanish mandate with an explicit preclinical filing item:

Toda la documentación se presentará en idioma español, en soporte impreso y electrónico.
— CECMED Regulación 21-08

read together with a “PARTE III: Información No Clínica” and an explicit reference to “los reportes de los estudios individuales.” — CECMED Regulación 21-08

The general clause plus the explicit list of individual-study reports reaches underlying preclinical reports.

Ecuador

Ecuador's ARCSA and its institutional CEI CEISH-INSPI both write broad Spanish-language mandates, and Ecuador is the one country in the region that combines all three elements — a general Spanish rule, a specific preclinical-report filing item, and a sworn/official translation requirement:

17. Estudios preclínicos: se presentarán los estudios preclínicos que respalden la seguridad del producto en investigación.
— ARCSA Requisitos Ensayos Clínicos

read with:

Toda la documentación deberá ser presentada en idioma castellano… con su traducción oficial, debidamente apostillada o legalizada.
— ARCSA Requisitos Ensayos Clínicos; Acuerdo Ministerial 0075-2017 art. 9

CEISH-INSPI's internal reglamento (Art. 66) is unrestricted: “Todos los documentos deberán ser presentados en idioma castellano.” (CEISH-INSPI Reglamento). Ecuador is the jurisdiction where an over-translation-avoidance posture faces the sharpest resistance.

Nicaragua

MINSA's Normativa - 166 pairs a general translate-into-Spanish clause with a specific animal-toxicity filing item:

Toda la información que se solicite en la presente normativa debe ser presentada en idioma original, traducido al español.
— MINSA Normativa - 166

read with:

Estudio previo de toxicidad en animales incluyendo carcinogenicidad y teratogenicidad.
— MINSA Normativa - 166

The submission list names toxicology, carcinogenicity, and teratogenicity as discrete deliverables, and the general clause requires them in Spanish.

Paraguay — but only at the committee layer

Paraguay is the unusual case: the regulator, DINAVISA, is not on the OPPOSES list — its current INF-DI-01 requires the Investigator's Brochure bilingually (Spanish and English), with no standalone preclinical-report translation duty. But the Comité de Ética en Investigación of the Instituto Nacional de Salud, operating under the Comité Nacional de Bioética, writes broadly:

En caso de que la documentación se encuentre en otro idioma, se deberá adjuntar una traducción de todos los documentos, hechas por traductor oficial.
— CEI-INS Reglamento

together with a submission-list item requiring “los estudios preclínicos disponibles.” — CEI-INS Reglamento

Paraguay is the only instance in the region of a committee inventing a translation duty its regulator did not create. For sponsors filing at institutions other than CEI-INS, the DINAVISA rule is what governs; for filings that route through CEI-INS specifically, the committee rule bites.

The 14 countries where the tightened claim holds

Across Argentina, Bolivia, Chile, Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Panama, Peru, Uruguay, and Venezuela, no regulator and no ethics committee we could find requires translation of the underlying preclinical reports. The rule that governs preclinical is a Spanish summary inside the Investigator's Brochure body. The underlying reports — biocompatibility, toxicology, ISO 14971, IEC 60601, design V&V, cleaning validation — are not called into the file as translated deliverables.

Four of these countries deserve specific mention because their rules are the clearest.

Mexico — preclinical as summary

Mexico's clinical-trial requirements sheet is explicit that what the regulator asks for is not a report but a summary:

Resumen de la información preclínica y clínica previamente obtenida (Manual del investigador o documento equivalente)
— COFEPRIS-04-010-A

The requirements sheet regulates format, but contains no occurrence of idioma, español, traducción, traducido or inglés. Mexico's Reglamento LGS closes the loop by confining the ethics committee to reviewing “los riesgos, los beneficios y la carta de consentimiento” (Reglamento LGS Art. 109) — participant protection, not technical-dossier review. The national bioethics gatekeeper, CONBIOÉTICA, additionally permits documentation in Spanish or in another language where the committee has the means to review it.

Colombia — one sworn translation, and it isn't preclinical

Colombia's clinical trial guide ASS-RSA-GU030 requires the protocol and IB in Spanish and English — a bilingual filing, not a translation directive on the underlying annex. The guide's only sworn-translation clause covers one document:

I. Certificado de cumplimiento de las Buenas Prácticas de Manufactura del fabricante del producto en investigación, con su respectiva apostilla, legalización y traducción oficial al idioma castellano.
— ASS-RSA-GU030

The GMP certificate. Not the toxicology report. Not the biocompatibility file. Not the risk analysis.

And in December 2025, INVIMA issued the region's only regulator-published instrument addressed specifically to ethics committees, the Guía para los comités de ética en investigación (ASS-RSA-GU040). The guide is entirely silent on translation and on the language of preclinical documents, the IB, and scientific technical annexes. Its only language directive attaches to informed-consent style (“lenguaje claro y comprensible”) — INVIMA ASS-RSA-GU040 (Dec 2025). A CEI-directed regulator instrument, issued in December 2025, with nothing to say about translating the preclinical annex, is unusually strong evidence that the topic is out of scope for the ethics committee.

Panama — preclinical rides in the IB, no language rule

Panama's Decreto Ejecutivo 1843 de 2014 expects preclinical content to arrive inside the Investigator's Brochure:

Folleto o manual del investigador, en donde, además de la información esencial, aparezcan todas las referencias clínicas y/o preclínicas de la molécula o medicamento en estudio.
— DE 1843/2014

The decree's only translation obligation is for the informed consent form in indigenous-language contexts. Every other document — including the IB carrying the preclinical references — is silent on language.

Argentina — a correction on the record

The clearest quote in the LATAM preclinical-translation debate is Argentina's Disposición ANMAT 6677/2010:

Todos los documentos que se sometan a esta Administración deben presentarse en idioma español, a excepción de la MPI dado que ésta sólo se utiliza como antecedente del estudio.
— Disposición ANMAT 6677/2010 (InfoLeg)

That quote is real, and it was decisive for 15 years. It is no longer operative. Disposición ANMAT 7516/2025, effective 1 December 2025, derogated 6677/2010 in full. The successor's annexes — retrievable at InfoLeg (Anexo II) and InfoLeg (Anexo III) — do not preserve the MPI carve-out. They contain no general language rule at all. Instead, 7516/2025 sets a document-specific architecture: Spanish for recruitment material, product labelling, and investigator CVs; sworn (“traductor matriculado”) translation for the sponsor's delegation of functions and foreign-authority approvals; silence on language for the MPI, protocol, IMPD, informed consent, and safety reports.

The backstop is Ley 20305 art. 6, which requires sworn translation of any foreign-language document submitted to a national administrative body. In practice, ANMAT reviewers now have discretion under that general statute. The MPI-in-English carve-out that used to be an express regulatory allowance is now an administrative silence with a legacy practice.

For sponsors filing in Argentina in 2026 and beyond, the correct posture is: Spanish IB is safer than English IB, notwithstanding the historical carve-out, until the new administrative practice consolidates.

The pattern that survives across all 19 countries

Three findings hold across the entire dataset, once the counterexamples are named honestly.

Language rules attach to a closed list, and no rule specifically names a preclinical report on that list. Across the 50 instruments read, every regulator that writes a language rule names some subset of: protocol, IB body, informed consent form, regulator's evaluation form, product label, patient-facing materials, GMP certificate. Not one instrument in the region specifically names biocompatibility, toxicology, GLP raw data, ISO 14971, design V&V, cleaning validation, packaging validation, calibration, IEC 60601, or IEC 62304 test reports as a required translated deliverable. Where the general translate-everything clause reaches these documents (the 5-country exception), it does so by aggregation, not by specific naming.
Where sworn or certified translation is required, it attaches to legal-status documents, not scientific ones. Colombia binds sworn translation to the GMP certificate. Argentina 7516/2025 binds it to the sponsor's delegation-of-authority and foreign-authority approvals. Panama binds it to the ICF in indigenous-language contexts. WCG IRB binds it to consent forms and participant materials. In 17 of 19 LATAM countries, the sworn-translation premium never touches a scientific technical annex. The two exceptions — Ecuador and Paraguay's CEI-INS — are the countries where a sworn-translation regime reaches the scientific dossier.
Preclinical evidence is regulated as summarized narrative inside the Investigator's Brochure across the majority of the region. Mexico (“resumen”), Colombia (“breve resumen”), Panama (“referencias”), Dominican Republic (preclinical as evaluation criterion, not filing item), El Salvador (IB summary), Guatemala (IB summary), Argentina 7516/2025 (IB required with no language rule attached), and the institutional CEIs inheriting from each of these all converge on the same regulatory construction. The IB body carries the Spanish summary; the underlying reports are neither required nor translated.

Amavita Sciences™ — where this fits

Amavita Sciences™ is the translational-services layer we built to keep the required work rigorous — protocol, IB body, ICF, labels, patient materials — while giving sponsors the analytical honesty to stop paying for the unrequired work. Every deliverable we release ships with a bilingual page-by-page layout, a findings report classified across four severity tiers, exact citations to the source page, and a correction cycle at no additional charge.

On the underlying preclinical reports, our default is summary translation inside the IB body with the underlying report referenced in English, unless the specific regulator on the specific program (Brazil CEP, Cuba, Ecuador, Nicaragua, Paraguay CEI-INS) says otherwise. That default reflects the research above.

If your program includes preclinical documentation you have been translating in full, we can review your scope in a single call against the same 50-entity source base this article draws from, and tell you exactly where the regulator's own text supports narrowing.

You can reach us here or through your usual bioaccess® contact.

Frequently asked questions

Do LATAM regulators require preclinical study reports to be translated into Spanish?: Not as a class. Across 19 Latin American countries and 50 primary-source instruments, no regulator or ethics committee writes a rule that specifically names a biocompatibility dossier, a toxicology report, an ISO 14971 file, a design V&V, a cleaning validation, or an IEC 60601 test report as a required translated deliverable. In 14 of 19 countries, the underlying preclinical reports are neither required as translated deliverables nor treated as reachable by any general translate-clause. In 5 of 19 countries — Brazil, Cuba, Ecuador, Nicaragua, and Paraguay's CEI-INS specifically — a general Spanish/Portuguese mandate combined with a preclinical filing item does reach those reports in principle.
What must be translated into Spanish for a LATAM clinical trial submission?: The closed list, consistent across the region, is: the protocol, the Investigator's Brochure body, the informed consent form, investigator CVs, product labels and instructions for use, and patient-facing materials. Colombia additionally requires a bilingual (Spanish and English) filing of the protocol and IB for drug studies. Sworn translation is limited to specific legal-status documents: Colombia's GMP certificate; Argentina 7516/2025's sponsor delegation-of-authority and foreign-authority approvals; Panama's ICF in indigenous-language contexts; WCG IRB's participant materials. Ecuador and Paraguay's CEI-INS are the two jurisdictions where a sworn/official-translation regime reaches beyond legal-status documents into the scientific dossier.
Does Argentina still exempt the Investigator's Brochure from the Spanish-language requirement?: Not by express clause. Disposición ANMAT 6677/2010 §2.4 did — its language was: “Todos los documentos… deben presentarse en idioma español, a excepción de la MPI dado que ésta sólo se utiliza como antecedente del estudio.” That disposition was derogated by Disp. 7516/2025 effective 1 December 2025. The successor's annexes contain no general language rule and no MPI carve-out. The MPI-in-English practice now survives as administrative discretion under Ley 20305 art. 6, not as an express regulatory allowance.
Does Brazil require preclinical annexes to be translated into Portuguese?: Yes at the ethics-committee layer, by aggregation. CONEP Norma Operacional 001/2013 requires all requested documentation in Portuguese with foreign-language originals attached. Institutional CEPs restate the rule; UFSCar's mandatory-documents list explicitly reaches the “trabalhos que fundamentam a experimentação prévia” — underlying preclinical works. ANVISA RDC 947/2024 art. 11 accepts English or Spanish outright and applies a “tradução livre” (free translation) standard for anything requiring translation, but no Brazilian trial reaches ANVISA without CEP/CONEP review, so the CEP posture governs.
Does Brazil require sworn (juramentada) translation of clinical trial documents?: No. ANVISA RDC 947/2024 art. 11 §3 is dispositive: “na ausência de norma específica que exija tradução na versão juramentada, poderá ser aceita tradução livre.” Brazil's sworn-translation regime is a judicial-procedure and civil-registry standard (Código de Processo Civil art. 192, Código Civil art. 224, LINDB art. 15, CNJ Resolução 155) that fires only where a foreign-language document enters the Brazilian civil-procedure or registry system — which the clinical trial dossier does not, unless collateral litigation or contract-registration is triggered.
Does WCG IRB require preclinical reports to be translated?: No. WCG's translation regime attaches only to consent forms and participant materials, with a formal Certificate of Translation from the translator. The Investigator's Brochure is required “in most cases” with no translation obligation, and preclinical reports are not a WCG submission item at all.
Which LATAM countries require sworn/official translation that reaches the scientific dossier?: Two: Ecuador (ARCSA's Acuerdo Ministerial 0075-2017 art. 9 requires “traducción oficial, debidamente apostillada o legalizada” for all documentation, combined with the specific preclinical-report filing item at requirement 17) and Paraguay at the CEI-INS layer specifically (“traductor oficial” for all foreign-language documents, combined with the “estudios preclínicos disponibles” filing item). In the other 17 countries, sworn or certified translation attaches only to legal-status documents (GMP certificates, delegation instruments, foreign-authority approvals, ICFs in indigenous-language contexts), never to the scientific technical annex.

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Julio G. Martinez-Clark

Co-Founder & CEO, bioaccess® · Founder, Amavita Sciences™

Julio leads bioaccess®, a first-in-human clinical trial CRO operating across Latin America, and Amavita Sciences™, regulatory language infrastructure for LATAM clinical trial and medical device submissions. bioaccess® has filed clinical trial dossiers with national regulators and ethics committees in Colombia, the Dominican Republic, Mexico, Panama, and El Salvador.

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Translating a preclinical annex in full? We will review your scope against the same 50-instrument source base behind this article.