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.
How ISP compares to the rest of the world.
ISP does not set its rules in isolation. Our primary-source review of preclinical translation requirements across nine LATAM regulators places Chile on the same three-tier map used above, so you can see where ISP is stricter — and where it is more permissive — than its neighbours.
Outside the region the picture changes again. The companion study of preclinical translation rules at eight non-LATAM regulators, from FDA and EMA to PMDA, NMPA, MHRA, Health Canada, TGA and Swissmedic found no primary instrument requiring visual replication of a Module 4 study report, which is why the sworn-translation ceiling described on this page is a LATAM-native construct.
If you are budgeting a multi-country programme, read the three-tier framework for ISP preclinical translation in the LATAM regulator study before deciding what to translate for Chile.
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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.