Your company is filing with Anvisa, Brazil's health regulator, or opening a clinical trial site in Brazil. The protocol, the Investigator's Brochure and the regulatory documents are in English. The question on the project plan is simple: which of these have to be in Portuguese, and who will translate them?
This guide answers it with Anvisa's own rules, so your regulatory team can plan the translation before the filing date gets close. Our native Brazilian Portuguese team translates pharma, clinical and medical documents for companies in India and worldwide.
Have a dossier or protocol to translate now? Get a quote or Connect us on WhatsApp. Send the files and your filing date, and we reply with a quote.
This is general guidance, not regulatory or legal advice. Confirm the requirements for your specific petition with your regulatory affairs team.
The basic rule: Anvisa works in Portuguese
Anvisa's rule on filing documents, RDC 947/2024, sets the language in article 11 (full text):
- Documents filed with Anvisa must be in Portuguese.
- Documents in English and Spanish are accepted, but Anvisa may ask you to send a translation.
- When a translation is needed and no specific rule requires a sworn version, a free translation (tradução livre, a professional translation that is not sworn) may be accepted.
Anvisa repeats this in its filing FAQ. In practice, an English document can go in, but a translation request from the reviewer can arrive later, while your file waits. Having the Portuguese ready avoids that delay.
Clinical trials: three documents that must be in Portuguese
Clinical trials in Brazil are governed by RDC 945/2024. Anvisa's official Q&A on clinical research (version 5.0, October 2026, item 5.3.9) is clear. For the clinical development dossier (DDCM), the trial-specific dossier (DEEC) and substantial amendments, these documents must be presented in Portuguese:
- Investigational Medicinal Product Development Plan (PDME)
- Clinical Protocol
- Investigator's Brochure (Brochura do Investigador)
The other documents may be filed in English or Spanish, but Anvisa says Portuguese is preferred whenever possible. Its DDCM/DEEC submission manual goes further and recommends submitting all documentation in Portuguese, because the reviewer can ask for a translation.
Planning a Brazilian trial? Send the protocol and brochure first. Get a quote or Connect us on WhatsApp.
Patient-facing documents: clarity is a rule
Research with people in Brazil follows the National Health Council's Resolution 466/2012. It says the informed consent form (TCLE) must contain all necessary information "in clear and objective language, easy to understand" (item II.23). Researchers must give information in clear, accessible language suited to the participant's culture, age and socioeconomic condition (item IV.1).
A word-for-word translation of an English consent form often fails that test. Patients in Brazil need natural Brazilian Portuguese, not European Portuguese and not machine output. That is exactly where a native translator matters. See why in Brazilian vs European Portuguese and AI vs human translation.
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Pick your document. Guidance only — confirm with your regulatory team.
What we translate for pharma and life-science companies
- Clinical protocols, amendments and synopses
- Investigator's Brochures and development plans
- Informed consent forms (TCLE) and assent forms
- Patient questionnaires, diaries and recruitment material
- Regulatory correspondence and responses to Anvisa requests
- Quality, manufacturing and technical documents
- Medical reports, discharge summaries and test results
- Medicine and medical device information for the Brazilian market
We work in both directions: English to Brazilian Portuguese, and Portuguese to English when Brazilian sites send documents back (Portuguese to English translation). See also our document translation and business translation services, and the industries we serve.
Have a protocol, brochure or consent form on your desk right now? Get a quote or Connect us on WhatsApp.
Free translation or sworn translation?
| Document use | What usually works |
|---|---|
| Anvisa petition where no rule asks for a sworn version | Professional native translation (tradução livre), per RDC 947/2024 art. 11 §3 |
| Clinical protocol, Investigator's Brochure, PDME | Professional native Portuguese translation, consistent across all documents |
| Consent forms and patient material | Native Brazilian Portuguese written for patients, reviewed for clarity |
| Legal or public documents where a rule requires a sworn version | Sworn translation (tradução juramentada) by a sworn public translator in Brazil |
We are honest about the last row. Sworn translations for Brazil are signed by sworn public translators registered there, and we do not claim that accreditation. Our sworn translation guide explains how it works. For everything else in the table, our native team delivers the professional translation.
How we handle pharma documents
Our team is led by Layla Correa Mishra, Lead Native Brazilian Portuguese Translator. For regulated documents we:
- assign native Brazilian Portuguese translators to the project;
- keep the same terms across the protocol, brochure and consent form, so the documents agree with each other;
- use translation memory and glossary tools, and can work with your approved glossary;
- flag any source term that is unclear, so your team decides instead of us guessing;
Interactive check
Anvisa language rules: true or false?
Guidance only — not regulatory or legal advice.
How to get a quote
- Send the files through the quote form or WhatsApp: Word, PDF or scans.
- Tell us the purpose: Anvisa filing, ethics committee, trial site or internal review.
- Share your filing date and any glossary or earlier translations.
- Get your quote. Every project is quoted individually, based on length, subject and deadline. Our cost guide explains what affects the price.
- Receive the translation, with notes on any terms your team should confirm.
Getting files ready? Read how to prepare documents for translation.
Sources
- Anvisa RDC 947/2024 — art. 11
- Anvisa filing FAQ — Protocolo, informações gerais
- Anvisa Q&A on clinical research — RDC 945/2024 and IN 338, version 5.0, October 2026, item 5.3.9
- Anvisa DDCM/DEEC submission manual — 24 February 2025
- Anvisa RDC 945/2024 — published in the Official Gazette (DOU), 29 November 2024
- CNS Resolution 466/2012 — items II.23 and IV.1
File with confidence
Send your protocol, brochure or Anvisa documents to our native Brazilian Portuguese team today: Get a quote or Connect us on WhatsApp.
Need pharma or clinical documents in Portuguese?
See our document translation and business translation services, or request a quote for your protocol or dossier.
Frequently asked questions
Does Anvisa accept documents in English?
Yes. RDC 947/2024 art. 11 accepts English and Spanish, but says documents must be in Portuguese and that Anvisa may ask for a translation.
Which clinical trial documents must be in Portuguese?
Anvisa's Q&A on RDC 945/2024 (version 5.0, item 5.3.9) says the development plan (PDME), the clinical protocol and the Investigator's Brochure must be in Portuguese. Other documents may be in English or Spanish, with Portuguese preferred.
Does a translation for Anvisa have to be sworn?
Not always. Under RDC 947/2024 art. 11 §3, a free (non-sworn) translation may be accepted when no specific rule requires a sworn version.
What language rules apply to the informed consent form?
CNS Resolution 466/2012 requires clear, objective, easy-to-understand language, adapted to the participant's culture, age and socioeconomic condition.
How much does pharmaceutical translation cost?
We quote every project individually based on length, subject and deadline. Request a quote and we reply with a price for your files.
Do you translate medical reports for patients too?
Yes. Send the reports through the quote form or WhatsApp and tell us where they will be used.
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