IDMP ISO 11238

IDMP Substance ID SSI.

Definition

ISO 11238:2018 distinguishes 6 categories: Chemical, Protein, Nucleic Acid, Polymer, Structurally Diverse, Mixture. Each substance carries a unique SSI. EMA Substance Database and FDA GSRS (Global Substance Registration System) implement ISO 11238 with ~150000 referenced substances.

Origin

ISO 11238 published 2018 by ISO/TC 215 ; revision in progress for ISO 11238:2024.

Example in context

The paracetamol SSI is used on EMA SmPCs and FDA labels, aligning worldwide regulatory references.

Related terms

• ISO 11239 — form and packaging.