Response to Regulatory Questions (RTQ)
0.1.0 - ci-build
Response to Regulatory Questions (RTQ), published by HL7 International. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/rtq-ig/ and changes regularly. See the Directory of published versions
| Draft as of 2025-11-11 |
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem ctd-categories-full</b></p><a name=\"ctd-categories-full\"> </a><a name=\"hcctd-categories-full\"> </a><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full</code> defines the following codes in a Is-A hierarchy:</p><table class=\"codes\"><tr><td><b>Lvl</b></td><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td>1</td><td style=\"white-space:nowrap\">summaries<a name=\"ctd-categories-full-summaries\"> </a></td><td>CTD Summaries</td><td>Module 2 – CTD Summaries</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0summaries.quality<a name=\"ctd-categories-full-summaries.46quality\"> </a></td><td>Quality Overall Summary</td><td>2.3 Quality Overall Summary</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0summaries.quality.intro<a name=\"ctd-categories-full-summaries.46quality.46intro\"> </a></td><td>Introduction</td><td>2.3.S/P Introduction</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0summaries.quality.body<a name=\"ctd-categories-full-summaries.46quality.46body\"> </a></td><td>Body of Data</td><td>2.3.S/P Body of Data</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0summaries.quality.literature<a name=\"ctd-categories-full-summaries.46quality.46literature\"> </a></td><td>Literature References</td><td>2.3.S/P Literature References</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0summaries.nonclinical<a name=\"ctd-categories-full-summaries.46nonclinical\"> </a></td><td>Nonclinical Overview</td><td>2.4 Nonclinical Overview</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0summaries.nonclinical.pharmacology<a name=\"ctd-categories-full-summaries.46nonclinical.46pharmacology\"> </a></td><td>Pharmacology</td><td>2.4.1-2 Pharmacology</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0summaries.nonclinical.pk<a name=\"ctd-categories-full-summaries.46nonclinical.46pk\"> </a></td><td>Pharmacokinetics</td><td>2.4.3 Pharmacokinetics</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0summaries.nonclinical.tox<a name=\"ctd-categories-full-summaries.46nonclinical.46tox\"> </a></td><td>Toxicology</td><td>2.4.4-6 Toxicology</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0summaries.clinical<a name=\"ctd-categories-full-summaries.46clinical\"> </a></td><td>Clinical Overview</td><td>2.5 Clinical Overview</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0summaries.clinical.efficacy<a name=\"ctd-categories-full-summaries.46clinical.46efficacy\"> </a></td><td>Efficacy</td><td>2.5.2 Efficacy</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0summaries.clinical.safety<a name=\"ctd-categories-full-summaries.46clinical.46safety\"> </a></td><td>Safety</td><td>2.5.3 Safety</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0summaries.clinical.brm<a name=\"ctd-categories-full-summaries.46clinical.46brm\"> </a></td><td>Benefit-Risk Assessment</td><td>2.5.4 Benefit-Risk</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0summaries.synopses<a name=\"ctd-categories-full-summaries.46synopses\"> </a></td><td>Synopses of Individual Studies</td><td>2.7 Synopses of Individual Studies</td></tr><tr><td>1</td><td style=\"white-space:nowrap\">quality<a name=\"ctd-categories-full-quality\"> </a></td><td>Quality (CMC)</td><td>Module 3 – Quality</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0quality.drug-substance<a name=\"ctd-categories-full-quality.46drug-substance\"> </a></td><td>Drug Substance</td><td>3.2.S Drug Substance</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-substance.general<a name=\"ctd-categories-full-quality.46drug-substance.46general\"> </a></td><td>General Information</td><td>3.2.S.1 General Information</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.general.nomenclature<a name=\"ctd-categories-full-quality.46drug-substance.46general.46nomenclature\"> </a></td><td>Nomenclature</td><td>3.2.S.1.1 Nomenclature</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.general.structure<a name=\"ctd-categories-full-quality.46drug-substance.46general.46structure\"> </a></td><td>Structure</td><td>3.2.S.1.2 Structure</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.general.properties<a name=\"ctd-categories-full-quality.46drug-substance.46general.46properties\"> </a></td><td>General Properties</td><td>3.2.S.1.3 General Properties</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-substance.manufacture<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture\"> </a></td><td>Manufacture</td><td>3.2.S.2 Manufacture</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.manufacture.manufacturer<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture.46manufacturer\"> </a></td><td>Manufacturer</td><td>3.2.S.2.1 Manufacturer</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.manufacture.description<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture.46description\"> </a></td><td>Description of Manufacturing Process and Process Controls</td><td>3.2.S.2.2 Description of Manufacturing Process</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.manufacture.controls<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture.46controls\"> </a></td><td>Control of Materials</td><td>3.2.S.2.3 Control of Materials</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.manufacture.critical-steps<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture.46critical-steps\"> </a></td><td>Controls of Critical Steps and Intermediates</td><td>3.2.S.2.4 Controls of Critical Steps and Intermediates</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.manufacture.validation<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture.46validation\"> </a></td><td>Process Validation and/or Evaluation</td><td>3.2.S.2.5 Process Validation</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.manufacture.development<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture.46development\"> </a></td><td>Manufacturing Process Development</td><td>3.2.S.2.6 Manufacturing Process Development</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-substance.characterisation<a name=\"ctd-categories-full-quality.46drug-substance.46characterisation\"> </a></td><td>Characterisation</td><td>3.2.S.3 Characterisation</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.characterisation.elucidation<a name=\"ctd-categories-full-quality.46drug-substance.46characterisation.46elucidation\"> </a></td><td>Elucidation of Structure and Other Characteristics</td><td>3.2.S.3.1 Elucidation of Structure</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.characterisation.impurities<a name=\"ctd-categories-full-quality.46drug-substance.46characterisation.46impurities\"> </a></td><td>Impurities</td><td>3.2.S.3.2 Impurities</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-substance.control<a name=\"ctd-categories-full-quality.46drug-substance.46control\"> </a></td><td>Control of Drug Substance</td><td>3.2.S.4 Control of Drug Substance</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.control.specification<a name=\"ctd-categories-full-quality.46drug-substance.46control.46specification\"> </a></td><td>Specification</td><td>3.2.S.4.1 Specification</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.control.analytical<a name=\"ctd-categories-full-quality.46drug-substance.46control.46analytical\"> </a></td><td>Analytical Procedures</td><td>3.2.S.4.2 Analytical Procedures</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.control.validation<a name=\"ctd-categories-full-quality.46drug-substance.46control.46validation\"> </a></td><td>Validation of Analytical Procedures</td><td>3.2.S.4.3 Validation of Analytical Procedures</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.control.batch<a name=\"ctd-categories-full-quality.46drug-substance.46control.46batch\"> </a></td><td>Batch Analyses</td><td>3.2.S.4.4 Batch Analyses</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.control.justification<a name=\"ctd-categories-full-quality.46drug-substance.46control.46justification\"> </a></td><td>Justification of Specification</td><td>3.2.S.4.5 Justification of Specification</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-substance.reference<a name=\"ctd-categories-full-quality.46drug-substance.46reference\"> </a></td><td>Reference Standards or Materials</td><td>3.2.S.5 Reference Standards</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-substance.container<a name=\"ctd-categories-full-quality.46drug-substance.46container\"> </a></td><td>Container Closure System</td><td>3.2.S.6 Container Closure System</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-substance.stability<a name=\"ctd-categories-full-quality.46drug-substance.46stability\"> </a></td><td>Stability</td><td>3.2.S.7 Stability</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.stability.summary<a name=\"ctd-categories-full-quality.46drug-substance.46stability.46summary\"> </a></td><td>Stability Summary and Conclusions</td><td>3.2.S.7.1 Stability Summary</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.stability.protocol<a name=\"ctd-categories-full-quality.46drug-substance.46stability.46protocol\"> </a></td><td>Post-approval Stability Protocol and Commitment</td><td>3.2.S.7.2 Post-approval Protocol</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-substance.stability.data<a name=\"ctd-categories-full-quality.46drug-substance.46stability.46data\"> </a></td><td>Stability Data</td><td>3.2.S.7.3 Stability Data</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0quality.drug-product<a name=\"ctd-categories-full-quality.46drug-product\"> </a></td><td>Drug Product</td><td>3.2.P Drug Product</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-product.description<a name=\"ctd-categories-full-quality.46drug-product.46description\"> </a></td><td>Description and Composition of the Drug Product</td><td>3.2.P.1 Description and Composition</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-product.pharmaceutical-development<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development\"> </a></td><td>Pharmaceutical Development</td><td>3.2.P.2 Pharmaceutical Development</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.pharmaceutical-development.components<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development.46components\"> </a></td><td>Components of the Drug Product</td><td>3.2.P.2.1 Components</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.pharmaceutical-development.drug-product<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development.46drug-product\"> </a></td><td>Drug Product</td><td>3.2.P.2.2 Drug Product</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.pharmaceutical-development.manufacturing<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development.46manufacturing\"> </a></td><td>Manufacturing Process Development</td><td>3.2.P.2.3 Manufacturing Process Development</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.pharmaceutical-development.container<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development.46container\"> </a></td><td>Container Closure System</td><td>3.2.P.2.4 Container Closure System</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.pharmaceutical-development.microbiological<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development.46microbiological\"> </a></td><td>Microbiological Attributes</td><td>3.2.P.2.5 Microbiological Attributes</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.pharmaceutical-development.compatibility<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development.46compatibility\"> </a></td><td>Compatibility</td><td>3.2.P.2.6 Compatibility</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-product.manufacture<a name=\"ctd-categories-full-quality.46drug-product.46manufacture\"> </a></td><td>Manufacture</td><td>3.2.P.3 Manufacture</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.manufacture.manufacturer<a name=\"ctd-categories-full-quality.46drug-product.46manufacture.46manufacturer\"> </a></td><td>Manufacturer(s)</td><td>3.2.P.3.1 Manufacturer(s)</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.manufacture.batch<a name=\"ctd-categories-full-quality.46drug-product.46manufacture.46batch\"> </a></td><td>Batch Formula</td><td>3.2.P.3.2 Batch Formula</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.manufacture.process<a name=\"ctd-categories-full-quality.46drug-product.46manufacture.46process\"> </a></td><td>Description of Manufacturing Process and Process Controls</td><td>3.2.P.3.3 Description of Manufacturing Process</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.manufacture.controls<a name=\"ctd-categories-full-quality.46drug-product.46manufacture.46controls\"> </a></td><td>Controls of Critical Steps and Intermediates</td><td>3.2.P.3.4 Controls of Critical Steps</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.manufacture.validation<a name=\"ctd-categories-full-quality.46drug-product.46manufacture.46validation\"> </a></td><td>Process Validation and/or Evaluation</td><td>3.2.P.3.5 Process Validation</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-product.excipients<a name=\"ctd-categories-full-quality.46drug-product.46excipients\"> </a></td><td>Control of Excipients</td><td>3.2.P.4 Control of Excipients</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.excipients.specifications<a name=\"ctd-categories-full-quality.46drug-product.46excipients.46specifications\"> </a></td><td>Specifications</td><td>3.2.P.4.1 Specifications</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.excipients.analytical<a name=\"ctd-categories-full-quality.46drug-product.46excipients.46analytical\"> </a></td><td>Analytical Procedures</td><td>3.2.P.4.2 Analytical Procedures</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.excipients.validation<a name=\"ctd-categories-full-quality.46drug-product.46excipients.46validation\"> </a></td><td>Validation of Analytical Procedures</td><td>3.2.P.4.3 Validation</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.excipients.justification<a name=\"ctd-categories-full-quality.46drug-product.46excipients.46justification\"> </a></td><td>Justification of Specifications</td><td>3.2.P.4.4 Justification</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.excipients.novel<a name=\"ctd-categories-full-quality.46drug-product.46excipients.46novel\"> </a></td><td>Novel Excipients</td><td>3.2.P.4.5 Novel Excipients</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-product.control<a name=\"ctd-categories-full-quality.46drug-product.46control\"> </a></td><td>Control of Drug Product</td><td>3.2.P.5 Control of Drug Product</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.control.specification<a name=\"ctd-categories-full-quality.46drug-product.46control.46specification\"> </a></td><td>Specification</td><td>3.2.P.5.1 Specification</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.control.analytical<a name=\"ctd-categories-full-quality.46drug-product.46control.46analytical\"> </a></td><td>Analytical Procedures</td><td>3.2.P.5.2 Analytical Procedures</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.control.validation<a name=\"ctd-categories-full-quality.46drug-product.46control.46validation\"> </a></td><td>Validation of Analytical Procedures</td><td>3.2.P.5.3 Validation</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.control.batch<a name=\"ctd-categories-full-quality.46drug-product.46control.46batch\"> </a></td><td>Batch Analyses</td><td>3.2.P.5.4 Batch Analyses</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.control.characterisation<a name=\"ctd-categories-full-quality.46drug-product.46control.46characterisation\"> </a></td><td>Characterisation of Impurities</td><td>3.2.P.5.5 Characterisation of Impurities</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.control.justification<a name=\"ctd-categories-full-quality.46drug-product.46control.46justification\"> </a></td><td>Justification of Specification</td><td>3.2.P.5.6 Justification</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-product.reference<a name=\"ctd-categories-full-quality.46drug-product.46reference\"> </a></td><td>Reference Standards or Materials</td><td>3.2.P.6 Reference Standards</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-product.container<a name=\"ctd-categories-full-quality.46drug-product.46container\"> </a></td><td>Container Closure System</td><td>3.2.P.7 Container Closure System</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.drug-product.stability<a name=\"ctd-categories-full-quality.46drug-product.46stability\"> </a></td><td>Stability</td><td>3.2.P.8 Stability</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.stability.summary<a name=\"ctd-categories-full-quality.46drug-product.46stability.46summary\"> </a></td><td>Stability Summary and Conclusions</td><td>3.2.P.8.1 Stability Summary</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.stability.protocol<a name=\"ctd-categories-full-quality.46drug-product.46stability.46protocol\"> </a></td><td>Post-approval Stability Protocol and Commitment</td><td>3.2.P.8.2 Post-approval Protocol</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0quality.drug-product.stability.data<a name=\"ctd-categories-full-quality.46drug-product.46stability.46data\"> </a></td><td>Stability Data</td><td>3.2.P.8.3 Stability Data</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0quality.appendices<a name=\"ctd-categories-full-quality.46appendices\"> </a></td><td>Appendices</td><td>3.2.A Appendices</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.appendices.facilities<a name=\"ctd-categories-full-quality.46appendices.46facilities\"> </a></td><td>Facilities and Equipment</td><td>3.2.A.1 Facilities and Equipment</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.appendices.adventitious<a name=\"ctd-categories-full-quality.46appendices.46adventitious\"> </a></td><td>Adventitious Agents Safety Evaluation</td><td>3.2.A.2 Adventitious Agents</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0quality.appendices.novel-excipients<a name=\"ctd-categories-full-quality.46appendices.46novel-excipients\"> </a></td><td>Novel Excipients</td><td>3.2.A.3 Novel Excipients</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0quality.regional<a name=\"ctd-categories-full-quality.46regional\"> </a></td><td>Regional Information</td><td>3.3 Regional Information</td></tr><tr><td>1</td><td style=\"white-space:nowrap\">nonclinical<a name=\"ctd-categories-full-nonclinical\"> </a></td><td>Nonclinical Study Reports</td><td>Module 4 – Nonclinical Study Reports</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0nonclinical.pharmacology<a name=\"ctd-categories-full-nonclinical.46pharmacology\"> </a></td><td>Pharmacology</td><td>4.2 Pharmacology</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.pharmacology.primary<a name=\"ctd-categories-full-nonclinical.46pharmacology.46primary\"> </a></td><td>Primary Pharmacodynamics</td><td>4.2.1.1 Primary Pharmacodynamics</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.pharmacology.secondary<a name=\"ctd-categories-full-nonclinical.46pharmacology.46secondary\"> </a></td><td>Secondary Pharmacodynamics</td><td>4.2.1.2 Secondary Pharmacodynamics</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.pharmacology.safety<a name=\"ctd-categories-full-nonclinical.46pharmacology.46safety\"> </a></td><td>Safety Pharmacology</td><td>4.2.1.3 Safety Pharmacology</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.pharmacology.discussion<a name=\"ctd-categories-full-nonclinical.46pharmacology.46discussion\"> </a></td><td>Pharmacodynamic Drug Interactions</td><td>4.2.1.4 Pharmacodynamic Drug Interactions</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0nonclinical.pk<a name=\"ctd-categories-full-nonclinical.46pk\"> </a></td><td>Pharmacokinetics</td><td>4.2.2 Pharmacokinetics</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.pk.absorption<a name=\"ctd-categories-full-nonclinical.46pk.46absorption\"> </a></td><td>Absorption</td><td>4.2.2.1 Absorption</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.pk.distribution<a name=\"ctd-categories-full-nonclinical.46pk.46distribution\"> </a></td><td>Distribution</td><td>4.2.2.2 Distribution</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.pk.metabolism<a name=\"ctd-categories-full-nonclinical.46pk.46metabolism\"> </a></td><td>Metabolism</td><td>4.2.2.3 Metabolism</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.pk.excretion<a name=\"ctd-categories-full-nonclinical.46pk.46excretion\"> </a></td><td>Excretion</td><td>4.2.2.4 Excretion</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.pk.interactions<a name=\"ctd-categories-full-nonclinical.46pk.46interactions\"> </a></td><td>PK Drug Interactions</td><td>4.2.2.5 PK Drug Interactions</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0nonclinical.toxicology<a name=\"ctd-categories-full-nonclinical.46toxicology\"> </a></td><td>Toxicology</td><td>4.2.3 Toxicology</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.single<a name=\"ctd-categories-full-nonclinical.46toxicology.46single\"> </a></td><td>Single-Dose Toxicity</td><td>4.2.3.1 Single-Dose Toxicity</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.repeat<a name=\"ctd-categories-full-nonclinical.46toxicology.46repeat\"> </a></td><td>Repeat-Dose Toxicity</td><td>4.2.3.2 Repeat-Dose Toxicity</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.geno<a name=\"ctd-categories-full-nonclinical.46toxicology.46geno\"> </a></td><td>Genotoxicity</td><td>4.2.3.3 Genotoxicity</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.geno.invitro<a name=\"ctd-categories-full-nonclinical.46toxicology.46geno.46invitro\"> </a></td><td>In Vitro</td><td>4.2.3.3.1 In Vitro</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.geno.invivo<a name=\"ctd-categories-full-nonclinical.46toxicology.46geno.46invivo\"> </a></td><td>In Vivo</td><td>4.2.3.3.2 In Vivo</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.carc<a name=\"ctd-categories-full-nonclinical.46toxicology.46carc\"> </a></td><td>Carcinogenicity</td><td>4.2.3.4 Carcinogenicity</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.repro<a name=\"ctd-categories-full-nonclinical.46toxicology.46repro\"> </a></td><td>Reproductive and Developmental Toxicity</td><td>4.2.3.5 Reproductive Toxicity</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.repro.fertility<a name=\"ctd-categories-full-nonclinical.46toxicology.46repro.46fertility\"> </a></td><td>Fertility and Early Embryonic Development</td><td>4.2.3.5.1 Fertility</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.repro.embryo<a name=\"ctd-categories-full-nonclinical.46toxicology.46repro.46embryo\"> </a></td><td>Embryo-Fetal Development</td><td>4.2.3.5.2 Embryo-Fetal</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.repro.peri<a name=\"ctd-categories-full-nonclinical.46toxicology.46repro.46peri\"> </a></td><td>Peri- and Post-Natal Development</td><td>4.2.3.5.3 Peri-/Post-Natal</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.local<a name=\"ctd-categories-full-nonclinical.46toxicology.46local\"> </a></td><td>Local Tolerance</td><td>4.2.3.6 Local Tolerance</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.other<a name=\"ctd-categories-full-nonclinical.46toxicology.46other\"> </a></td><td>Other Toxicity Studies</td><td>4.2.3.7 Other Toxicity Studies</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.other.antigenicity<a name=\"ctd-categories-full-nonclinical.46toxicology.46other.46antigenicity\"> </a></td><td>Antigenicity</td><td>4.2.3.7.1 Antigenicity</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.other.immunotox<a name=\"ctd-categories-full-nonclinical.46toxicology.46other.46immunotox\"> </a></td><td>Immunotoxicity</td><td>4.2.3.7.2 Immunotoxicity</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.other.mechanistic<a name=\"ctd-categories-full-nonclinical.46toxicology.46other.46mechanistic\"> </a></td><td>Mechanistic Studies</td><td>4.2.3.7.3 Mechanistic</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.other.impurities<a name=\"ctd-categories-full-nonclinical.46toxicology.46other.46impurities\"> </a></td><td>Impurities</td><td>4.2.3.7.4 Impurities</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.other.metabolites<a name=\"ctd-categories-full-nonclinical.46toxicology.46other.46metabolites\"> </a></td><td>Metabolites</td><td>4.2.3.7.5 Metabolites</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0nonclinical.toxicology.other.other<a name=\"ctd-categories-full-nonclinical.46toxicology.46other.46other\"> </a></td><td>Other</td><td>4.2.3.7.6 Other</td></tr><tr><td>1</td><td style=\"white-space:nowrap\">clinical<a name=\"ctd-categories-full-clinical\"> </a></td><td>Clinical Study Reports</td><td>Module 5 – Clinical Study Reports</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0clinical.biopharm<a name=\"ctd-categories-full-clinical.46biopharm\"> </a></td><td>Biopharmaceutic Studies</td><td>5.2 Biopharmaceutic Studies</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.biopharm.ba-be<a name=\"ctd-categories-full-clinical.46biopharm.46ba-be\"> </a></td><td>Bioavailability / Bioequivalence</td><td>5.2.1-2 BA/BE Studies</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.biopharm.invitro<a name=\"ctd-categories-full-clinical.46biopharm.46invitro\"> </a></td><td>In Vitro–In Vivo Correlation</td><td>5.2.3 IVIVC</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0clinical.pk<a name=\"ctd-categories-full-clinical.46pk\"> </a></td><td>Clinical Pharmacology Studies</td><td>5.3 Clinical Pharmacology</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.pk.healthy<a name=\"ctd-categories-full-clinical.46pk.46healthy\"> </a></td><td>Studies in Healthy Subjects</td><td>5.3.1 Healthy Subjects</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.pk.patient<a name=\"ctd-categories-full-clinical.46pk.46patient\"> </a></td><td>Studies in Target Population</td><td>5.3.2 Target Population</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.pk.intrinsic<a name=\"ctd-categories-full-clinical.46pk.46intrinsic\"> </a></td><td>Intrinsic Factors</td><td>5.3.3 Intrinsic Factors</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0clinical.pk.intrinsic.renal<a name=\"ctd-categories-full-clinical.46pk.46intrinsic.46renal\"> </a></td><td>Renal Impairment</td><td>5.3.3.1 Renal</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0clinical.pk.intrinsic.hepatic<a name=\"ctd-categories-full-clinical.46pk.46intrinsic.46hepatic\"> </a></td><td>Hepatic Impairment</td><td>5.3.3.2 Hepatic</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0clinical.pk.intrinsic.age<a name=\"ctd-categories-full-clinical.46pk.46intrinsic.46age\"> </a></td><td>Age / Pediatric</td><td>5.3.3.3 Age/Pediatric</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.pk.extrinsic<a name=\"ctd-categories-full-clinical.46pk.46extrinsic\"> </a></td><td>Extrinsic Factors</td><td>5.3.4 Extrinsic Factors</td></tr><tr><td>4</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0clinical.pk.extrinsic.ddi<a name=\"ctd-categories-full-clinical.46pk.46extrinsic.46ddi\"> </a></td><td>Drug-Drug Interactions</td><td>5.3.4.1 DDI</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.pk.pop<a name=\"ctd-categories-full-clinical.46pk.46pop\"> </a></td><td>Population PK</td><td>5.3.5 Population PK</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0clinical.efficacy<a name=\"ctd-categories-full-clinical.46efficacy\"> </a></td><td>Clinical Efficacy & Safety Studies</td><td>5.3.5-5.4 Efficacy and Safety</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.efficacy.controlled<a name=\"ctd-categories-full-clinical.46efficacy.46controlled\"> </a></td><td>Controlled Clinical Studies</td><td>5.3.5.1 Controlled Studies</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.efficacy.uncontrolled<a name=\"ctd-categories-full-clinical.46efficacy.46uncontrolled\"> </a></td><td>Uncontrolled Studies</td><td>5.3.5.2 Uncontrolled</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.efficacy.other<a name=\"ctd-categories-full-clinical.46efficacy.46other\"> </a></td><td>Other Studies</td><td>5.3.5.3 Other</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.efficacy.analysis<a name=\"ctd-categories-full-clinical.46efficacy.46analysis\"> </a></td><td>Analyses of Efficacy</td><td>5.3.5.4 Analyses</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0clinical.safety<a name=\"ctd-categories-full-clinical.46safety\"> </a></td><td>Safety Data</td><td>5.3.6 Safety</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.safety.exposure<a name=\"ctd-categories-full-clinical.46safety.46exposure\"> </a></td><td>Extent of Exposure</td><td>5.3.6.1 Exposure</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.safety.ae<a name=\"ctd-categories-full-clinical.46safety.46ae\"> </a></td><td>Adverse Events</td><td>5.3.6.2 AEs</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.safety.lab<a name=\"ctd-categories-full-clinical.46safety.46lab\"> </a></td><td>Clinical Laboratory</td><td>5.3.6.3 Lab</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.safety.vital<a name=\"ctd-categories-full-clinical.46safety.46vital\"> </a></td><td>Vital Signs / ECG</td><td>5.3.6.4 Vital/ECG</td></tr><tr><td>3</td><td style=\"white-space:nowrap\">\u00a0\u00a0\u00a0\u00a0clinical.safety.immuno<a name=\"ctd-categories-full-clinical.46safety.46immuno\"> </a></td><td>Immunogenicity</td><td>5.3.6.5 Immunogenicity</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0clinical.literature<a name=\"ctd-categories-full-clinical.46literature\"> </a></td><td>Literature References</td><td>5.4 Literature References</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a0clinical.synopses<a name=\"ctd-categories-full-clinical.46synopses\"> </a></td><td>Synopses of Individual Studies</td><td>5.3.7 Synopses</td></tr></table></div>"
},
"url" : "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full",
"version" : "0.1.0",
"name" : "CTDQuestionCategoriesFull",
"title" : "CTD-Based Regulatory Question Categories (Full Granularity)",
"status" : "draft",
"experimental" : true,
"date" : "2025-11-11",
"publisher" : "HL7 International",
"contact" : [
{
"name" : "HL7 International",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org"
}
]
}
],
"description" : "Hierarchical terminology derived from ICH CTD Modules 2-5 for classifying regulator-to-sponsor questions in Structured Regulatory Correspondence (SRC). Supports multi-level granularity for EMA, FDA, and Health Canada harmonization.",
"caseSensitive" : true,
"valueSet" : "http://hl7.org/fhir/uv/src-ig/ValueSet/vs-ctd-question-categories-full",
"hierarchyMeaning" : "is-a",
"content" : "complete",
"concept" : [
{
"code" : "summaries",
"display" : "CTD Summaries",
"definition" : "Module 2 – CTD Summaries",
"concept" : [
{
"code" : "summaries.quality",
"display" : "Quality Overall Summary",
"definition" : "2.3 Quality Overall Summary",
"concept" : [
{
"code" : "summaries.quality.intro",
"display" : "Introduction",
"definition" : "2.3.S/P Introduction"
},
{
"code" : "summaries.quality.body",
"display" : "Body of Data",
"definition" : "2.3.S/P Body of Data"
},
{
"code" : "summaries.quality.literature",
"display" : "Literature References",
"definition" : "2.3.S/P Literature References"
}
]
},
{
"code" : "summaries.nonclinical",
"display" : "Nonclinical Overview",
"definition" : "2.4 Nonclinical Overview",
"concept" : [
{
"code" : "summaries.nonclinical.pharmacology",
"display" : "Pharmacology",
"definition" : "2.4.1-2 Pharmacology"
},
{
"code" : "summaries.nonclinical.pk",
"display" : "Pharmacokinetics",
"definition" : "2.4.3 Pharmacokinetics"
},
{
"code" : "summaries.nonclinical.tox",
"display" : "Toxicology",
"definition" : "2.4.4-6 Toxicology"
}
]
},
{
"code" : "summaries.clinical",
"display" : "Clinical Overview",
"definition" : "2.5 Clinical Overview",
"concept" : [
{
"code" : "summaries.clinical.efficacy",
"display" : "Efficacy",
"definition" : "2.5.2 Efficacy"
},
{
"code" : "summaries.clinical.safety",
"display" : "Safety",
"definition" : "2.5.3 Safety"
},
{
"code" : "summaries.clinical.brm",
"display" : "Benefit-Risk Assessment",
"definition" : "2.5.4 Benefit-Risk"
}
]
},
{
"code" : "summaries.synopses",
"display" : "Synopses of Individual Studies",
"definition" : "2.7 Synopses of Individual Studies"
}
]
},
{
"code" : "quality",
"display" : "Quality (CMC)",
"definition" : "Module 3 – Quality",
"concept" : [
{
"code" : "quality.drug-substance",
"display" : "Drug Substance",
"definition" : "3.2.S Drug Substance",
"concept" : [
{
"code" : "quality.drug-substance.general",
"display" : "General Information",
"definition" : "3.2.S.1 General Information",
"concept" : [
{
"code" : "quality.drug-substance.general.nomenclature",
"display" : "Nomenclature",
"definition" : "3.2.S.1.1 Nomenclature"
},
{
"code" : "quality.drug-substance.general.structure",
"display" : "Structure",
"definition" : "3.2.S.1.2 Structure"
},
{
"code" : "quality.drug-substance.general.properties",
"display" : "General Properties",
"definition" : "3.2.S.1.3 General Properties"
}
]
},
{
"code" : "quality.drug-substance.manufacture",
"display" : "Manufacture",
"definition" : "3.2.S.2 Manufacture",
"concept" : [
{
"code" : "quality.drug-substance.manufacture.manufacturer",
"display" : "Manufacturer",
"definition" : "3.2.S.2.1 Manufacturer"
},
{
"code" : "quality.drug-substance.manufacture.description",
"display" : "Description of Manufacturing Process and Process Controls",
"definition" : "3.2.S.2.2 Description of Manufacturing Process"
},
{
"code" : "quality.drug-substance.manufacture.controls",
"display" : "Control of Materials",
"definition" : "3.2.S.2.3 Control of Materials"
},
{
"code" : "quality.drug-substance.manufacture.critical-steps",
"display" : "Controls of Critical Steps and Intermediates",
"definition" : "3.2.S.2.4 Controls of Critical Steps and Intermediates"
},
{
"code" : "quality.drug-substance.manufacture.validation",
"display" : "Process Validation and/or Evaluation",
"definition" : "3.2.S.2.5 Process Validation"
},
{
"code" : "quality.drug-substance.manufacture.development",
"display" : "Manufacturing Process Development",
"definition" : "3.2.S.2.6 Manufacturing Process Development"
}
]
},
{
"code" : "quality.drug-substance.characterisation",
"display" : "Characterisation",
"definition" : "3.2.S.3 Characterisation",
"concept" : [
{
"code" : "quality.drug-substance.characterisation.elucidation",
"display" : "Elucidation of Structure and Other Characteristics",
"definition" : "3.2.S.3.1 Elucidation of Structure"
},
{
"code" : "quality.drug-substance.characterisation.impurities",
"display" : "Impurities",
"definition" : "3.2.S.3.2 Impurities"
}
]
},
{
"code" : "quality.drug-substance.control",
"display" : "Control of Drug Substance",
"definition" : "3.2.S.4 Control of Drug Substance",
"concept" : [
{
"code" : "quality.drug-substance.control.specification",
"display" : "Specification",
"definition" : "3.2.S.4.1 Specification"
},
{
"code" : "quality.drug-substance.control.analytical",
"display" : "Analytical Procedures",
"definition" : "3.2.S.4.2 Analytical Procedures"
},
{
"code" : "quality.drug-substance.control.validation",
"display" : "Validation of Analytical Procedures",
"definition" : "3.2.S.4.3 Validation of Analytical Procedures"
},
{
"code" : "quality.drug-substance.control.batch",
"display" : "Batch Analyses",
"definition" : "3.2.S.4.4 Batch Analyses"
},
{
"code" : "quality.drug-substance.control.justification",
"display" : "Justification of Specification",
"definition" : "3.2.S.4.5 Justification of Specification"
}
]
},
{
"code" : "quality.drug-substance.reference",
"display" : "Reference Standards or Materials",
"definition" : "3.2.S.5 Reference Standards"
},
{
"code" : "quality.drug-substance.container",
"display" : "Container Closure System",
"definition" : "3.2.S.6 Container Closure System"
},
{
"code" : "quality.drug-substance.stability",
"display" : "Stability",
"definition" : "3.2.S.7 Stability",
"concept" : [
{
"code" : "quality.drug-substance.stability.summary",
"display" : "Stability Summary and Conclusions",
"definition" : "3.2.S.7.1 Stability Summary"
},
{
"code" : "quality.drug-substance.stability.protocol",
"display" : "Post-approval Stability Protocol and Commitment",
"definition" : "3.2.S.7.2 Post-approval Protocol"
},
{
"code" : "quality.drug-substance.stability.data",
"display" : "Stability Data",
"definition" : "3.2.S.7.3 Stability Data"
}
]
}
]
},
{
"code" : "quality.drug-product",
"display" : "Drug Product",
"definition" : "3.2.P Drug Product",
"concept" : [
{
"code" : "quality.drug-product.description",
"display" : "Description and Composition of the Drug Product",
"definition" : "3.2.P.1 Description and Composition"
},
{
"code" : "quality.drug-product.pharmaceutical-development",
"display" : "Pharmaceutical Development",
"definition" : "3.2.P.2 Pharmaceutical Development",
"concept" : [
{
"code" : "quality.drug-product.pharmaceutical-development.components",
"display" : "Components of the Drug Product",
"definition" : "3.2.P.2.1 Components"
},
{
"code" : "quality.drug-product.pharmaceutical-development.drug-product",
"display" : "Drug Product",
"definition" : "3.2.P.2.2 Drug Product"
},
{
"code" : "quality.drug-product.pharmaceutical-development.manufacturing",
"display" : "Manufacturing Process Development",
"definition" : "3.2.P.2.3 Manufacturing Process Development"
},
{
"code" : "quality.drug-product.pharmaceutical-development.container",
"display" : "Container Closure System",
"definition" : "3.2.P.2.4 Container Closure System"
},
{
"code" : "quality.drug-product.pharmaceutical-development.microbiological",
"display" : "Microbiological Attributes",
"definition" : "3.2.P.2.5 Microbiological Attributes"
},
{
"code" : "quality.drug-product.pharmaceutical-development.compatibility",
"display" : "Compatibility",
"definition" : "3.2.P.2.6 Compatibility"
}
]
},
{
"code" : "quality.drug-product.manufacture",
"display" : "Manufacture",
"definition" : "3.2.P.3 Manufacture",
"concept" : [
{
"code" : "quality.drug-product.manufacture.manufacturer",
"display" : "Manufacturer(s)",
"definition" : "3.2.P.3.1 Manufacturer(s)"
},
{
"code" : "quality.drug-product.manufacture.batch",
"display" : "Batch Formula",
"definition" : "3.2.P.3.2 Batch Formula"
},
{
"code" : "quality.drug-product.manufacture.process",
"display" : "Description of Manufacturing Process and Process Controls",
"definition" : "3.2.P.3.3 Description of Manufacturing Process"
},
{
"code" : "quality.drug-product.manufacture.controls",
"display" : "Controls of Critical Steps and Intermediates",
"definition" : "3.2.P.3.4 Controls of Critical Steps"
},
{
"code" : "quality.drug-product.manufacture.validation",
"display" : "Process Validation and/or Evaluation",
"definition" : "3.2.P.3.5 Process Validation"
}
]
},
{
"code" : "quality.drug-product.excipients",
"display" : "Control of Excipients",
"definition" : "3.2.P.4 Control of Excipients",
"concept" : [
{
"code" : "quality.drug-product.excipients.specifications",
"display" : "Specifications",
"definition" : "3.2.P.4.1 Specifications"
},
{
"code" : "quality.drug-product.excipients.analytical",
"display" : "Analytical Procedures",
"definition" : "3.2.P.4.2 Analytical Procedures"
},
{
"code" : "quality.drug-product.excipients.validation",
"display" : "Validation of Analytical Procedures",
"definition" : "3.2.P.4.3 Validation"
},
{
"code" : "quality.drug-product.excipients.justification",
"display" : "Justification of Specifications",
"definition" : "3.2.P.4.4 Justification"
},
{
"code" : "quality.drug-product.excipients.novel",
"display" : "Novel Excipients",
"definition" : "3.2.P.4.5 Novel Excipients"
}
]
},
{
"code" : "quality.drug-product.control",
"display" : "Control of Drug Product",
"definition" : "3.2.P.5 Control of Drug Product",
"concept" : [
{
"code" : "quality.drug-product.control.specification",
"display" : "Specification",
"definition" : "3.2.P.5.1 Specification"
},
{
"code" : "quality.drug-product.control.analytical",
"display" : "Analytical Procedures",
"definition" : "3.2.P.5.2 Analytical Procedures"
},
{
"code" : "quality.drug-product.control.validation",
"display" : "Validation of Analytical Procedures",
"definition" : "3.2.P.5.3 Validation"
},
{
"code" : "quality.drug-product.control.batch",
"display" : "Batch Analyses",
"definition" : "3.2.P.5.4 Batch Analyses"
},
{
"code" : "quality.drug-product.control.characterisation",
"display" : "Characterisation of Impurities",
"definition" : "3.2.P.5.5 Characterisation of Impurities"
},
{
"code" : "quality.drug-product.control.justification",
"display" : "Justification of Specification",
"definition" : "3.2.P.5.6 Justification"
}
]
},
{
"code" : "quality.drug-product.reference",
"display" : "Reference Standards or Materials",
"definition" : "3.2.P.6 Reference Standards"
},
{
"code" : "quality.drug-product.container",
"display" : "Container Closure System",
"definition" : "3.2.P.7 Container Closure System"
},
{
"code" : "quality.drug-product.stability",
"display" : "Stability",
"definition" : "3.2.P.8 Stability",
"concept" : [
{
"code" : "quality.drug-product.stability.summary",
"display" : "Stability Summary and Conclusions",
"definition" : "3.2.P.8.1 Stability Summary"
},
{
"code" : "quality.drug-product.stability.protocol",
"display" : "Post-approval Stability Protocol and Commitment",
"definition" : "3.2.P.8.2 Post-approval Protocol"
},
{
"code" : "quality.drug-product.stability.data",
"display" : "Stability Data",
"definition" : "3.2.P.8.3 Stability Data"
}
]
}
]
},
{
"code" : "quality.appendices",
"display" : "Appendices",
"definition" : "3.2.A Appendices",
"concept" : [
{
"code" : "quality.appendices.facilities",
"display" : "Facilities and Equipment",
"definition" : "3.2.A.1 Facilities and Equipment"
},
{
"code" : "quality.appendices.adventitious",
"display" : "Adventitious Agents Safety Evaluation",
"definition" : "3.2.A.2 Adventitious Agents"
},
{
"code" : "quality.appendices.novel-excipients",
"display" : "Novel Excipients",
"definition" : "3.2.A.3 Novel Excipients"
}
]
},
{
"code" : "quality.regional",
"display" : "Regional Information",
"definition" : "3.3 Regional Information"
}
]
},
{
"code" : "nonclinical",
"display" : "Nonclinical Study Reports",
"definition" : "Module 4 – Nonclinical Study Reports",
"concept" : [
{
"code" : "nonclinical.pharmacology",
"display" : "Pharmacology",
"definition" : "4.2 Pharmacology",
"concept" : [
{
"code" : "nonclinical.pharmacology.primary",
"display" : "Primary Pharmacodynamics",
"definition" : "4.2.1.1 Primary Pharmacodynamics"
},
{
"code" : "nonclinical.pharmacology.secondary",
"display" : "Secondary Pharmacodynamics",
"definition" : "4.2.1.2 Secondary Pharmacodynamics"
},
{
"code" : "nonclinical.pharmacology.safety",
"display" : "Safety Pharmacology",
"definition" : "4.2.1.3 Safety Pharmacology"
},
{
"code" : "nonclinical.pharmacology.discussion",
"display" : "Pharmacodynamic Drug Interactions",
"definition" : "4.2.1.4 Pharmacodynamic Drug Interactions"
}
]
},
{
"code" : "nonclinical.pk",
"display" : "Pharmacokinetics",
"definition" : "4.2.2 Pharmacokinetics",
"concept" : [
{
"code" : "nonclinical.pk.absorption",
"display" : "Absorption",
"definition" : "4.2.2.1 Absorption"
},
{
"code" : "nonclinical.pk.distribution",
"display" : "Distribution",
"definition" : "4.2.2.2 Distribution"
},
{
"code" : "nonclinical.pk.metabolism",
"display" : "Metabolism",
"definition" : "4.2.2.3 Metabolism"
},
{
"code" : "nonclinical.pk.excretion",
"display" : "Excretion",
"definition" : "4.2.2.4 Excretion"
},
{
"code" : "nonclinical.pk.interactions",
"display" : "PK Drug Interactions",
"definition" : "4.2.2.5 PK Drug Interactions"
}
]
},
{
"code" : "nonclinical.toxicology",
"display" : "Toxicology",
"definition" : "4.2.3 Toxicology",
"concept" : [
{
"code" : "nonclinical.toxicology.single",
"display" : "Single-Dose Toxicity",
"definition" : "4.2.3.1 Single-Dose Toxicity"
},
{
"code" : "nonclinical.toxicology.repeat",
"display" : "Repeat-Dose Toxicity",
"definition" : "4.2.3.2 Repeat-Dose Toxicity"
},
{
"code" : "nonclinical.toxicology.geno",
"display" : "Genotoxicity",
"definition" : "4.2.3.3 Genotoxicity",
"concept" : [
{
"code" : "nonclinical.toxicology.geno.invitro",
"display" : "In Vitro",
"definition" : "4.2.3.3.1 In Vitro"
},
{
"code" : "nonclinical.toxicology.geno.invivo",
"display" : "In Vivo",
"definition" : "4.2.3.3.2 In Vivo"
}
]
},
{
"code" : "nonclinical.toxicology.carc",
"display" : "Carcinogenicity",
"definition" : "4.2.3.4 Carcinogenicity"
},
{
"code" : "nonclinical.toxicology.repro",
"display" : "Reproductive and Developmental Toxicity",
"definition" : "4.2.3.5 Reproductive Toxicity",
"concept" : [
{
"code" : "nonclinical.toxicology.repro.fertility",
"display" : "Fertility and Early Embryonic Development",
"definition" : "4.2.3.5.1 Fertility"
},
{
"code" : "nonclinical.toxicology.repro.embryo",
"display" : "Embryo-Fetal Development",
"definition" : "4.2.3.5.2 Embryo-Fetal"
},
{
"code" : "nonclinical.toxicology.repro.peri",
"display" : "Peri- and Post-Natal Development",
"definition" : "4.2.3.5.3 Peri-/Post-Natal"
}
]
},
{
"code" : "nonclinical.toxicology.local",
"display" : "Local Tolerance",
"definition" : "4.2.3.6 Local Tolerance"
},
{
"code" : "nonclinical.toxicology.other",
"display" : "Other Toxicity Studies",
"definition" : "4.2.3.7 Other Toxicity Studies",
"concept" : [
{
"code" : "nonclinical.toxicology.other.antigenicity",
"display" : "Antigenicity",
"definition" : "4.2.3.7.1 Antigenicity"
},
{
"code" : "nonclinical.toxicology.other.immunotox",
"display" : "Immunotoxicity",
"definition" : "4.2.3.7.2 Immunotoxicity"
},
{
"code" : "nonclinical.toxicology.other.mechanistic",
"display" : "Mechanistic Studies",
"definition" : "4.2.3.7.3 Mechanistic"
},
{
"code" : "nonclinical.toxicology.other.impurities",
"display" : "Impurities",
"definition" : "4.2.3.7.4 Impurities"
},
{
"code" : "nonclinical.toxicology.other.metabolites",
"display" : "Metabolites",
"definition" : "4.2.3.7.5 Metabolites"
},
{
"code" : "nonclinical.toxicology.other.other",
"display" : "Other",
"definition" : "4.2.3.7.6 Other"
}
]
}
]
}
]
},
{
"code" : "clinical",
"display" : "Clinical Study Reports",
"definition" : "Module 5 – Clinical Study Reports",
"concept" : [
{
"code" : "clinical.biopharm",
"display" : "Biopharmaceutic Studies",
"definition" : "5.2 Biopharmaceutic Studies",
"concept" : [
{
"code" : "clinical.biopharm.ba-be",
"display" : "Bioavailability / Bioequivalence",
"definition" : "5.2.1-2 BA/BE Studies"
},
{
"code" : "clinical.biopharm.invitro",
"display" : "In Vitro–In Vivo Correlation",
"definition" : "5.2.3 IVIVC"
}
]
},
{
"code" : "clinical.pk",
"display" : "Clinical Pharmacology Studies",
"definition" : "5.3 Clinical Pharmacology",
"concept" : [
{
"code" : "clinical.pk.healthy",
"display" : "Studies in Healthy Subjects",
"definition" : "5.3.1 Healthy Subjects"
},
{
"code" : "clinical.pk.patient",
"display" : "Studies in Target Population",
"definition" : "5.3.2 Target Population"
},
{
"code" : "clinical.pk.intrinsic",
"display" : "Intrinsic Factors",
"definition" : "5.3.3 Intrinsic Factors",
"concept" : [
{
"code" : "clinical.pk.intrinsic.renal",
"display" : "Renal Impairment",
"definition" : "5.3.3.1 Renal"
},
{
"code" : "clinical.pk.intrinsic.hepatic",
"display" : "Hepatic Impairment",
"definition" : "5.3.3.2 Hepatic"
},
{
"code" : "clinical.pk.intrinsic.age",
"display" : "Age / Pediatric",
"definition" : "5.3.3.3 Age/Pediatric"
}
]
},
{
"code" : "clinical.pk.extrinsic",
"display" : "Extrinsic Factors",
"definition" : "5.3.4 Extrinsic Factors",
"concept" : [
{
"code" : "clinical.pk.extrinsic.ddi",
"display" : "Drug-Drug Interactions",
"definition" : "5.3.4.1 DDI"
}
]
},
{
"code" : "clinical.pk.pop",
"display" : "Population PK",
"definition" : "5.3.5 Population PK"
}
]
},
{
"code" : "clinical.efficacy",
"display" : "Clinical Efficacy & Safety Studies",
"definition" : "5.3.5-5.4 Efficacy and Safety",
"concept" : [
{
"code" : "clinical.efficacy.controlled",
"display" : "Controlled Clinical Studies",
"definition" : "5.3.5.1 Controlled Studies"
},
{
"code" : "clinical.efficacy.uncontrolled",
"display" : "Uncontrolled Studies",
"definition" : "5.3.5.2 Uncontrolled"
},
{
"code" : "clinical.efficacy.other",
"display" : "Other Studies",
"definition" : "5.3.5.3 Other"
},
{
"code" : "clinical.efficacy.analysis",
"display" : "Analyses of Efficacy",
"definition" : "5.3.5.4 Analyses"
}
]
},
{
"code" : "clinical.safety",
"display" : "Safety Data",
"definition" : "5.3.6 Safety",
"concept" : [
{
"code" : "clinical.safety.exposure",
"display" : "Extent of Exposure",
"definition" : "5.3.6.1 Exposure"
},
{
"code" : "clinical.safety.ae",
"display" : "Adverse Events",
"definition" : "5.3.6.2 AEs"
},
{
"code" : "clinical.safety.lab",
"display" : "Clinical Laboratory",
"definition" : "5.3.6.3 Lab"
},
{
"code" : "clinical.safety.vital",
"display" : "Vital Signs / ECG",
"definition" : "5.3.6.4 Vital/ECG"
},
{
"code" : "clinical.safety.immuno",
"display" : "Immunogenicity",
"definition" : "5.3.6.5 Immunogenicity"
}
]
},
{
"code" : "clinical.literature",
"display" : "Literature References",
"definition" : "5.4 Literature References"
},
{
"code" : "clinical.synopses",
"display" : "Synopses of Individual Studies",
"definition" : "5.3.7 Synopses"
}
]
}
]
}