Disposición 6677/10 (ANMAT)
ANMAT's Régimen de Buena Práctica Clínica for pharmacological studies in Argentina.
What it means
Disposición 6677/10 sets ANMAT's GCP regime, including sponsor, investigator, ethics, and documentation requirements. All submitted documents must be in Spanish, with sworn translations for foreign-origin documents and CTPCBA legalization when filed outside the translator's jurisdiction.
Why it matters for LATAM submissions
The disposición is the reference the ANMAT reviewer cites in observations. Mapping ICF, protocol, and IB translations against it during preparation prevents the majority of first-cycle findings.
Relevant regulators
ANMAT
Related terms
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