MedDRA
The Medical Dictionary for Regulatory Activities, the controlled terminology for adverse events and medical history.
What it means
MedDRA is the ICH-endorsed controlled medical terminology used to code adverse events, medical history, and indications. Spanish and Brazilian Portuguese MedDRA distributions are used across LATAM; translators must use the current MedDRA version's Lower Level Terms (LLTs) rather than free-text equivalents.
Why it matters for LATAM submissions
Free-text translation of an adverse event that does not map to an approved LLT breaks coding downstream and causes safety database queries in every country.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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