Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
Draft as of 2024-10-30 |
{
"resourceType" : "ValueSet",
"id" : "pqcmc-substance-name-type",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet pqcmc-substance-name-type</b></p><a name=\"pqcmc-substance-name-type\"> </a><a name=\"hcpqcmc-substance-name-type\"> </a><a name=\"pqcmc-substance-name-type-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"CodeSystem-cmc-ncit-dummy.html\"><code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C71898\">C71898</a></td><td>Brand</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C97054\">C97054</a></td><td>Generic Name</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C203355\">C203355</a></td><td>GSRS Preferred Term</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C203357\">C203357</a></td><td>Systematic Name</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C203358\">C203358</a></td><td>USP-NF Established Name</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C54682\">C54682</a></td><td>CAS Number</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C142585\">C142585</a></td><td>INN</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C96973\">C96973</a></td><td>USAN</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C203356\">C203356</a></td><td>IUPAC Name</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C95517\">C95517</a></td><td>ISBT-128 DIN</td></tr><tr><td><a href=\"CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C203354\">C203354</a></td><td>Company ID/Code</td></tr></table></li></ul></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}
],
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type",
"identifier" : [
{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.40.36.48.27"
}
],
"version" : "1.0.0",
"name" : "PqcmcSubstanceNameType",
"title" : "Substance Name Type",
"status" : "draft",
"experimental" : false,
"date" : "2024-10-30T15:40:50+00:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
{
"name" : "HL7 International / Biomedical Research and Regulation",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
},
{
"system" : "email",
"value" : "brr@lists.HL7.org"
}
]
}
],
"description" : "A category of terminology used to quality the information pertaining to the type of substance name in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "US",
"display" : "United States of America"
}
]
}
],
"compose" : {
"include" : [
{
"system" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy",
"concept" : [
{
"code" : "C71898",
"display" : "Brand"
},
{
"code" : "C97054",
"display" : "Generic Name"
},
{
"code" : "C203355",
"display" : "GSRS Preferred Term"
},
{
"code" : "C203357",
"display" : "Systematic Name"
},
{
"code" : "C203358",
"display" : "USP-NF Established Name"
},
{
"code" : "C54682",
"display" : "CAS Number"
},
{
"code" : "C142585",
"display" : "INN"
},
{
"code" : "C96973",
"display" : "USAN"
},
{
"code" : "C203356",
"display" : "IUPAC Name"
},
{
"code" : "C95517",
"display" : "ISBT-128 DIN"
},
{
"code" : "C203354",
"display" : "Company ID/Code"
}
]
}
]
}
}