Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology | Version: 1.0.0-ballot | |||
| Active as of 2024-04-08 | Computable Name: PqcmcSpecificationStatusTerminology | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.48.23 | ||||
Terminology used to qualify the information pertaining to specification statuses in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.
References
Expansion based on codesystem PQ-CMC-FDA Temporary Codes v1.0.0-ballot (CodeSystem)
This value set contains 5 concepts.
| Code | System | Display |
| C25425 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Approved |
| C48660 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Not Applicable |
| C134011 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Not Approved |
| C134012 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Reported in a CBE or AR |
| C134010 | http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy | Tentatively Approved |
Explanation of the columns that may appear on this page:
| Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies |
| System | The source of the definition of the code (when the value set draws in codes defined elsewhere) |
| Code | The code (used as the code in the resource instance) |
| Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application |
| Definition | An explanation of the meaning of the concept |
| Comments | Additional notes about how to use the code |
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-08
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