Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
The Food and Drug Administration (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. It profiles FHIR® documents to be submitted as XML files in Module 3 of the eCTD to the FDA. It was created under their sponsorship.
- IG Proposal
- Project Insight Number: 1537
- Project Confluence page: Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
- Project Scope Statement: Pharmaceutical Quality (PQ) PSS
- code: pq-cmc-fda
- canonical: http://hl7.org/fhir/us/pq-cmc-fda
- CI Build: https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda/
FHIR® is the registered trademark of HL7.