The FDA PQ-CMC FHIR IG is for submission of structured and standardized information regarding drug product quality, chemistry, manufacturing and processes controls. This data is intended for submission to the US FDA by biopharmaceutical companies for the purpose of drug application review. (built Tue, Jul 8, 2025 07:43+0000+00:00)
{
"description": "The FDA PQ-CMC FHIR IG is for submission of structured and standardized information regarding drug product quality, chemistry, manufacturing and processes controls. This data is intended for submission to the US FDA by biopharmaceutical companies for the purpose of drug application review. (built Tue, Jul 8, 2025 07:43+0000+00:00)",
"fhirVersions": [ "5.0.0" ],
"tools-version": 3,
"_id": "hl7.fhir.us.pq-cmc-fda@2.0.0",
"date": "20250708074310",
"license": "CC0-1.0",
"jurisdiction": "urn:iso:std:iso:3166#US",
"tgz": "-/hl7.fhir.us.pq-cmc-fda-2.0.0.tgz",
"dist": {
"tarball": "https://fs.get-ig.org/-/hl7.fhir.us.pq-cmc-fda-2.0.0.tgz"
},
"name": "hl7.fhir.us.pq-cmc-fda",
"type": "IG",
"title": "Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA",
"author": "HL7 International / Biomedical Research and Regulation",
"id": "hl7.fhir.us.pq-cmc-fda@2.0.0",
"directories": {
"lib": "package",
"example": "example"
},
"canonical": "http://hl7.org/fhir/us/pq-cmc-fda",
"url": "http://hl7.org/fhir/us/pq-cmc-fda/STU2",
"lsn": 772,
"version": "2.0.0",
"timestamp": "2025-07-08T09:30:54.880222693Z",
"maintainers": [ {
"url": "http://www.hl7.org/Special/committees/rcrim",
"name": "HL7 International / Biomedical Research and Regulation",
"email": "brr@lists.HL7.org"
} ],
"dependencies": {
"hl7.terminology.r5": "6.4.0",
"hl7.fhir.uv.extensions.r5": "5.2.0"
}
}