ANVISA & FDA: Navigating Pharmaceutical Translation Across Two Regulators

Two regulators, two sets of expectations

Pharmaceutical companies operating across Brazil and the United States submit essentially the same clinical and manufacturing data to two regulators that structure their review differently. ANVISA (Agência Nacional de Vigilância Sanitária) issues its rules through numbered resolutions known as RDCs (Resoluções da Diretoria Colegiada), and requires submissions in Portuguese, while the FDA reviews in English under its own procedural framework.

A dossier built to satisfy the FDA's expectations does not automatically satisfy ANVISA's, and the reverse is also true, which is why translation for this sector is closer to regulatory adaptation than to straightforward document conversion: the underlying science may transfer directly, but the way it needs to be presented, sectioned, and worded for each regulator generally does not.

Registration dossiers and structured formats

Many registration dossiers submitted to ANVISA follow a structure similar to the internationally recognized Common Technical Document (CTD) format, which organizes quality, nonclinical, and clinical data into standardized sections. Even where the underlying structure is similar to what was submitted to the FDA, the Portuguese-language version has to be built section by section with terminology that matches how ANVISA reviewers expect the same categories of data to be described, rather than translated as a single continuous document.

Inconsistent terminology between corresponding sections of the Portuguese and English dossiers is a common source of reviewer queries that can slow the registration timeline, particularly where a term used in the quality section of one language version does not match the term used for the same concept in the clinical section of the other.

GMP audit documentation

Good Manufacturing Practice (GMP) audit documentation, covering facility inspections, quality system records, and corrective action reports, is another recurring translation need, since ANVISA and the FDA both conduct GMP oversight of manufacturing facilities but generate and expect documentation in their own respective languages and formats.

A manufacturing site preparing for inspection by both regulators often maintains parallel documentation sets that need to describe the same processes and findings without drifting apart in how a given procedure or deviation is characterized, since an auditor comparing the Portuguese and English versions of a corrective action report will notice, and may query, any point where the two accounts of the same event no longer say the same thing.

Clinical trial protocols and package inserts

Clinical trial protocols conducted in Brazil, or extended to include Brazilian trial sites, need translation that keeps inclusion criteria, dosing instructions, and adverse-event terminology exact, since imprecision at this level affects how a study is actually conducted, not only how it reads.

Package inserts, known in Brazil as bulas, are similarly exacting: ANVISA regulates the specific content and format bulas must follow for both patient and healthcare-professional versions, and this is a distinct document type from the FDA's own prescribing information format, not a direct translation of it. A bula built by translating US prescribing information section-for-section, rather than by working from ANVISA's own required structure, typically needs substantial rework before it can be submitted.

Consistency across submissions

Keeping terminology consistent between the Portuguese and English versions of a submission, using the same rendering for a given drug substance, adverse event, or manufacturing term every time it appears, reduces the risk of clarifying questions or delays during regulatory review by either agency. This is typically managed through a maintained terminology glossary specific to the product and submission, checked by a second linguist against both language versions, rather than relying on translator memory alone across a submission that can run to hundreds of pages.

STIB's approach on this kind of work follows that same certified-translation-plus-second-linguist-review model rather than a single-pass translation, since a regulatory dossier is one of the few document types where a downstream reviewer, not just the client, is going to read every section closely.

Interpretation for regulatory and audit meetings

GMP facility inspections, regulatory clarification meetings, and cross-border technical discussions between a manufacturer's Brazilian and US-facing teams are common points where interpretation supports the same submission the translated documentation was built for. An interpreter working an ANVISA or FDA-facing meeting benefits from having already seen the specific terminology used in the site's translated GMP documentation, since a facility inspector's question about a procedure will typically reference the exact wording already used in the written record, and an interpreter unfamiliar with that wording risks introducing a term that does not match what the inspector is holding in front of them.