Comparison of Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA with US-Core

The following Profiles do not derive from US Core, and should be reviewed with the US Realm Committee:

• Document Reference Attachment
• Basic Organization
• Graphic Reference
• Structure Data Reference

US Realm	Current Build	Difference	Union	Intersection	Notes
ValueSets
Common Languages	All Languages	Comparison	Union	Intersection	83 Breaking Changes, 0 Changes, 4 Notes
All Security Labels	Example set of Security Labels	Comparison	Union	Intersection	1 Breaking Change, 1 Change, 14 Notes
US Core DocumentReference Type	FHIR Document Type Codes	Comparison	Union	Intersection	2 Breaking Changes, 0 Changes, 10 Notes
StructureDefinitions
US Core DocumentReference Profile	Document Reference Attachment	Comparison	Union	Intersection	4 Breaking Changes, 10 Changes, 44 Notes
US Core DocumentReference Profile	Graphic Reference	Comparison	Union	Intersection	5 Breaking Changes, 10 Changes, 44 Notes
US Core DocumentReference Profile	Structure Data Reference	Comparison	Union	Intersection	5 Breaking Changes, 10 Changes, 44 Notes
US Core Organization Profile	Basic Organization	Comparison	Union	Intersection	3 Breaking Changes, 5 Changes, 21 Notes