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 Thu, Dec 12, 2024 18:53+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 Thu, Dec 12, 2024 18:53+0000+00:00)",
"fhirVersions": [ "5.0.0" ],
"tools-version": 3,
"_id": "hl7.fhir.us.pq-cmc-fda@2.0.0-ballot",
"date": "20241212185304",
"license": "CC0-1.0",
"jurisdiction": "urn:iso:std:iso:3166#US",
"dist": {
"tarball": "https://fs.get-ig.org/-/hl7.fhir.us.pq-cmc-fda-2.0.0-ballot.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-ballot",
"directories": {
"lib": "package",
"example": "example"
},
"canonical": "http://hl7.org/fhir/us/pq-cmc-fda",
"url": "http://hl7.org/fhir/us/pq-cmc-fda/2025Jan",
"version": "2.0.0-ballot",
"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": "6.1.0",
"hl7.fhir.uv.extensions.r5": "5.1.0"
}
}