Submission-language requirements: which regulators accept English and which require Spanish or Portuguese, module by module

The question is per module, not per country

Language requirements are usually discussed as a country property: Brazil is Portuguese, Mexico is Spanish, the United States is English. That framing is what causes over-translation. Authorities do not set one language for a submission; they set obligations for specific kinds of content, and those obligations differ inside the same dossier.

A single ANVISA or COFEPRIS filing can legitimately contain English study reports, a national-language technical summary, fully Portuguese or Spanish labeling, and sworn-translated legal certificates. Deciding module by module is the difference between a proportionate budget and a blanket one.

LATAM: what each authority expects

The column that never varies is the middle one. Every LATAM authority in this table requires national-language labeling and patient-facing content, and no amount of dossier design changes that.

Global authorities: English as working language, with exceptions

• FDA — English throughout; foreign-language source material must be accompanied by a complete, accurate English translation.
• EMA — English for the centralised procedure dossier, with all EU official languages required for product information at authorisation.
• MHRA — English, with certified translation and a written confirmation of correctness for foreign-language documents.
• Health Canada — English or French; both for labeling and patient-facing content.
• TGA — English; translations must be accompanied by a translator declaration.
• Swissmedic — national language or English for much of the dossier, applicant-attested translations, national languages for product information.
• PMDA (Japan) — Japanese as the legal default, with a narrow conditional English route for eligible applicants after advance consultation.
• NMPA (China) — Chinese dossier, with the foreign-language original attached as reference.

Devices, pharmaceuticals, and biologics

Medical devices

The instructions for use and labeling are the binding constraint, and they are national language in every LATAM market. Technical files, standards test reports, and clinical evaluation annexes can usually stay in English with a national-language clinical summary. Device teams over-buy most often by translating the entire technical file for a market that only needed the IFU and a summary.

Pharmaceuticals

Modules 3 and 4 carry the most tolerance for English. Module 1 is administrative and national language by nature. Product information and labeling are national language and are also the documents most exposed to inconsistency, because they are revised late and often by a different party than the one who translated the dossier.

Biologics

Same rule set, larger surface. Comparability exercises, process validation, and analytical method documentation generate thousands of pages where an English core plus a rigorous national-language summary is both accepted and defensible. The risk in biologics is not language choice; it is terminology drift across a very large corpus.

Building one master, many national layers

1. Freeze an English technical master with a controlled terminology list.
2. Decide, per authority, which modules travel as-is and which need a national-language summary.
3. Build the national-language layer once per language, not once per country, and adapt only what regulation forces to differ.
4. Handle legal-status documents separately, on the sworn track, with the apostille sequence planned first.
5. Version everything against the master so a later amendment does not desynchronize five markets at once.

Sponsors who structure submissions this way tend to find that the translation question stops being about price per word and becomes a question about which content genuinely has to change language at all.

Frequently asked questions

Do LATAM regulators accept dossiers written in English?

Partly, and the answer is module-dependent rather than country-wide. Technical modules — nonclinical study reports, quality documentation, and large analytical annexes — are frequently accepted in English or accepted with a national-language summary. Administrative, legal, labeling, and patient-facing content is national language in every LATAM jurisdiction without exception.

Which content is always required in the national language?

Three groups. Labeling and instructions for use; informed consent and any patient-facing material; and legal-administrative documents such as powers of attorney, certificates, and corporate records. No regulator in this survey treats those as translatable-on-request — they are national language by default.

Is the language rule different for medical devices and pharmaceuticals?

The direction is the same but the pressure points differ. Device submissions concentrate national-language obligation in the IFU, labeling, and clinical evaluation summary. Pharmaceutical and biologic submissions concentrate it in product information, labeling, and the administrative module, while allowing more English in Modules 3 and 4.

Does Brazil require Portuguese for the whole ANVISA dossier?

No. Portuguese is required for labeling, product information, patient materials, and legal-administrative documents. Technical documentation has narrower obligations, and in practice a Portuguese summary of an English technical report is often the accepted middle path. Treating the entire dossier as full-Portuguese is a common and expensive misreading.

What about biologics — is the language rule stricter?

The language rule is not stricter, but the volume is larger and the consequence of inconsistency is higher. Biologics dossiers carry heavy CMC and comparability content, so a module-level language decision made early saves far more than it does for a small-molecule filing.

How should we handle a regulator whose guidance does not mention language?

Assume national language for anything with legal or patient effect, keep the source-language original for technical content, and add a substantive national-language summary so a reviewer never has to work in a foreign language to reach a conclusion. That default is accepted everywhere in this survey.

Can one English master dossier serve several LATAM countries?

Yes, as a master. The English technical core stays constant, and each country gets a national-language layer for labeling, patient-facing content, and legal documents. That structure is cheaper and far more consistent than commissioning country-by-country full translations of the same science.

Related reading

• Preclinical translation requirements across 9 LATAM regulators — the module-4 view of the same language question.
• What global regulators require for translating preclinical dossiers — FDA, EMA, PMDA, NMPA, MHRA, Health Canada, TGA and Swissmedic, source-anchored.
• Medical device translation services — IFU, labeling, and technical-file scope for device submissions.
• Pharmaceutical translation services — module-level scoping for pharma and biologics filings.
• Sworn vs. certified translation for regulatory submissions — which certification each LATAM regulator actually accepts.
• The costliest translation mistakes in regulatory filings — the error classes that trigger RFIs and how to catch them.

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