Chile · Spanish · ISP
ISP translation, built for the Chilean ANAMED review cycle.
What Chile's Instituto de Salud Pública (ISP/ANAMED) expects from Spanish clinical trial and registration documentation — and how an Amavita pilot delivers a package aligned to Chilean regulatory usage.
What this covers
ISP in three moving parts.
What must be in Chilean Spanish
Protocol, informed consent, investigator's brochure, SUSAR narratives, and product labeling — with Chilean medical terminology, not neutral Latin American Spanish.
Certification and notarization
Legal instruments require a traductor oficial and notarial legalization; foreign public documents follow apostille rules under the Chilean adherence to the Hague Convention.
Where submissions stall
Terminology drift from Chilean usage, ICFs written above the expected reading level, and inconsistent unit conventions trigger observaciones from ANAMED evaluators.
What must be in Chilean Spanish
Protocol, informed consent, investigator's brochure, SUSAR narratives, and product labeling — with Chilean medical terminology, not neutral Latin American Spanish.
Certification and notarization
Legal instruments require a traductor oficial and notarial legalization; foreign public documents follow apostille rules under the Chilean adherence to the Hague Convention.
Where submissions stall
Terminology drift from Chilean usage, ICFs written above the expected reading level, and inconsistent unit conventions trigger observaciones from ANAMED evaluators.
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Frequently asked
ISP translation, quick answers.
What language does ISP require for clinical trial submissions in Chile?
ISP's Agencia Nacional de Medicamentos (ANAMED) reviews clinical trial dossiers in Spanish. Protocols, informed consent forms, investigator's brochures, safety narratives, and product labeling must be translated into Chilean Spanish, with source-language documents accepted only when paired with a compliant translation.
Who certifies translations for ISP submissions?
Legal instruments and foreign public documents require a traductor oficial and, where applicable, notarial legalization and apostille. Technical documents such as protocols and investigator brochures should be prepared by qualified medical translators reviewed by clinicians familiar with ANAMED expectations.
How does the Amavita pilot cover ISP submissions?
A pilot scopes one Chilean protocol or dossier, delivers an MD-reviewed Spanish package aligned to ISP/ANAMED expectations, and includes a pre-submission QC checklist covering terminology, ICF readability, and legalization workflow.
Next step
Scope a Chile pilot this quarter.
Share your Chile protocol or registration dossier. Our team will reach out within 2 business days with a scoped pilot proposal and timeline.