Glossary
LATAM regulatory translation terms
A plain-language reference for the regulators, documents, quality steps, and certification types that shape clinical trial and marketing authorization submissions in Latin America.
Regulators
- ANVISABrazil's federal health surveillance agency that regulates clinical trials, medicines, medical devices, and cosmetics.
- COFEPRISMexico's Federal Commission for Protection against Health Risks, the regulator for clinical trials and marketing authorizations.
- INVIMAColombia's National Food and Drug Surveillance Institute, responsible for clinical trial and product registration review.
- ANMATArgentina's National Administration of Drugs, Foods and Medical Devices.
- DIGEMIDPeru's General Directorate of Medicines, Supplies, and Drugs.
- ARCSAEcuador's Agency for the Regulation, Control, and Sanitary Surveillance of Health Products.
- ISPChile's Public Health Institute, the regulator for clinical trials and health products.
- MINSAPanama's Ministry of Health, which oversees clinical trial and health product registration.
Translation & Certification
- Sworn translatorA translator authorized by a legal authority to certify translations for official submissions.
- Tradutor juramentadoBrazil's sworn public translator, required for legal instruments submitted to ANVISA.
- Perito traductorMexico's expert translator, often required for certified legal and regulatory translations.
- Certificate of accuracyA signed statement attesting that a translation is complete and accurate.
- ApostilleAn international certification that authenticates a public document for use in another country.
Quality Workflow
- Back-translationRe-translating a translated document into the source language to verify meaning is preserved.
- Adversarial back-translationA back-translation process designed to challenge the translation rather than simply reproduce it.
- Six-Gate QCAmavita's six-step quality workflow for regulatory translations.
- Cognitive debriefingA process that tests whether translated patient materials are understood as intended.
Documents & Dossiers
- ProtocolThe detailed plan that describes how a clinical trial will be conducted.
- Informed consent form (ICF)The document that explains a clinical trial to participants and captures their voluntary agreement.
- TCLEBrazil's informed consent form, the Termo de Consentimento Livre e Esclarecido.
- Instructions for Use (IFU)The document that tells patients or clinicians how to use a medical device or product.
- DossierThe complete set of documents submitted to a regulator for review.
- eCTDElectronic Common Technical Document, the standard format for regulatory submission dossiers.
- CMCChemistry, Manufacturing, and Controls — the quality module of a regulatory dossier.
Safety & Pharmacovigilance
- SAESerious Adverse Event, a safety event that must be reported to regulators and ethics committees.
- SUSARSuspected Unexpected Serious Adverse Reaction, a safety report requiring expedited regulatory submission.
- PharmacovigilanceThe science and practice of monitoring and reporting drug safety after approval.
- NOM-012Mexico's official standard for pharmacovigilance, including safety reporting in Spanish.
Submissions & Approvals
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