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

CodeSystem: CTD Question Categories Full (Experimental)

Official URL: http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full Version: 0.1.0
Draft as of 2025-11-11 Computable Name: CTDQuestionCategoriesFull

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.

This Code system is referenced in the content logical definition of the following value sets:

  • This CodeSystem is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

This case-sensitive code system http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full defines the following codes in a Is-A hierarchy:

LvlCodeDisplayDefinition
1 summaries CTD Summaries Module 2 – CTD Summaries
2   summaries.quality Quality Overall Summary 2.3 Quality Overall Summary
3     summaries.quality.intro Introduction 2.3.S/P Introduction
3     summaries.quality.body Body of Data 2.3.S/P Body of Data
3     summaries.quality.literature Literature References 2.3.S/P Literature References
2   summaries.nonclinical Nonclinical Overview 2.4 Nonclinical Overview
3     summaries.nonclinical.pharmacology Pharmacology 2.4.1-2 Pharmacology
3     summaries.nonclinical.pk Pharmacokinetics 2.4.3 Pharmacokinetics
3     summaries.nonclinical.tox Toxicology 2.4.4-6 Toxicology
2   summaries.clinical Clinical Overview 2.5 Clinical Overview
3     summaries.clinical.efficacy Efficacy 2.5.2 Efficacy
3     summaries.clinical.safety Safety 2.5.3 Safety
3     summaries.clinical.brm Benefit-Risk Assessment 2.5.4 Benefit-Risk
2   summaries.synopses Synopses of Individual Studies 2.7 Synopses of Individual Studies
1 quality Quality (CMC) Module 3 – Quality
2   quality.drug-substance Drug Substance 3.2.S Drug Substance
3     quality.drug-substance.general General Information 3.2.S.1 General Information
4       quality.drug-substance.general.nomenclature Nomenclature 3.2.S.1.1 Nomenclature
4       quality.drug-substance.general.structure Structure 3.2.S.1.2 Structure
4       quality.drug-substance.general.properties General Properties 3.2.S.1.3 General Properties
3     quality.drug-substance.manufacture Manufacture 3.2.S.2 Manufacture
4       quality.drug-substance.manufacture.manufacturer Manufacturer 3.2.S.2.1 Manufacturer
4       quality.drug-substance.manufacture.description Description of Manufacturing Process and Process Controls 3.2.S.2.2 Description of Manufacturing Process
4       quality.drug-substance.manufacture.controls Control of Materials 3.2.S.2.3 Control of Materials
4       quality.drug-substance.manufacture.critical-steps Controls of Critical Steps and Intermediates 3.2.S.2.4 Controls of Critical Steps and Intermediates
4       quality.drug-substance.manufacture.validation Process Validation and/or Evaluation 3.2.S.2.5 Process Validation
4       quality.drug-substance.manufacture.development Manufacturing Process Development 3.2.S.2.6 Manufacturing Process Development
3     quality.drug-substance.characterisation Characterisation 3.2.S.3 Characterisation
4       quality.drug-substance.characterisation.elucidation Elucidation of Structure and Other Characteristics 3.2.S.3.1 Elucidation of Structure
4       quality.drug-substance.characterisation.impurities Impurities 3.2.S.3.2 Impurities
3     quality.drug-substance.control Control of Drug Substance 3.2.S.4 Control of Drug Substance
4       quality.drug-substance.control.specification Specification 3.2.S.4.1 Specification
4       quality.drug-substance.control.analytical Analytical Procedures 3.2.S.4.2 Analytical Procedures
4       quality.drug-substance.control.validation Validation of Analytical Procedures 3.2.S.4.3 Validation of Analytical Procedures
4       quality.drug-substance.control.batch Batch Analyses 3.2.S.4.4 Batch Analyses
4       quality.drug-substance.control.justification Justification of Specification 3.2.S.4.5 Justification of Specification
3     quality.drug-substance.reference Reference Standards or Materials 3.2.S.5 Reference Standards
3     quality.drug-substance.container Container Closure System 3.2.S.6 Container Closure System
3     quality.drug-substance.stability Stability 3.2.S.7 Stability
4       quality.drug-substance.stability.summary Stability Summary and Conclusions 3.2.S.7.1 Stability Summary
4       quality.drug-substance.stability.protocol Post-approval Stability Protocol and Commitment 3.2.S.7.2 Post-approval Protocol
4       quality.drug-substance.stability.data Stability Data 3.2.S.7.3 Stability Data
2   quality.drug-product Drug Product 3.2.P Drug Product
3     quality.drug-product.description Description and Composition of the Drug Product 3.2.P.1 Description and Composition
3     quality.drug-product.pharmaceutical-development Pharmaceutical Development 3.2.P.2 Pharmaceutical Development
4       quality.drug-product.pharmaceutical-development.components Components of the Drug Product 3.2.P.2.1 Components
4       quality.drug-product.pharmaceutical-development.drug-product Drug Product 3.2.P.2.2 Drug Product
4       quality.drug-product.pharmaceutical-development.manufacturing Manufacturing Process Development 3.2.P.2.3 Manufacturing Process Development
4       quality.drug-product.pharmaceutical-development.container Container Closure System 3.2.P.2.4 Container Closure System
4       quality.drug-product.pharmaceutical-development.microbiological Microbiological Attributes 3.2.P.2.5 Microbiological Attributes
4       quality.drug-product.pharmaceutical-development.compatibility Compatibility 3.2.P.2.6 Compatibility
3     quality.drug-product.manufacture Manufacture 3.2.P.3 Manufacture
4       quality.drug-product.manufacture.manufacturer Manufacturer(s) 3.2.P.3.1 Manufacturer(s)
4       quality.drug-product.manufacture.batch Batch Formula 3.2.P.3.2 Batch Formula
4       quality.drug-product.manufacture.process Description of Manufacturing Process and Process Controls 3.2.P.3.3 Description of Manufacturing Process
4       quality.drug-product.manufacture.controls Controls of Critical Steps and Intermediates 3.2.P.3.4 Controls of Critical Steps
4       quality.drug-product.manufacture.validation Process Validation and/or Evaluation 3.2.P.3.5 Process Validation
3     quality.drug-product.excipients Control of Excipients 3.2.P.4 Control of Excipients
4       quality.drug-product.excipients.specifications Specifications 3.2.P.4.1 Specifications
4       quality.drug-product.excipients.analytical Analytical Procedures 3.2.P.4.2 Analytical Procedures
4       quality.drug-product.excipients.validation Validation of Analytical Procedures 3.2.P.4.3 Validation
4       quality.drug-product.excipients.justification Justification of Specifications 3.2.P.4.4 Justification
4       quality.drug-product.excipients.novel Novel Excipients 3.2.P.4.5 Novel Excipients
3     quality.drug-product.control Control of Drug Product 3.2.P.5 Control of Drug Product
4       quality.drug-product.control.specification Specification 3.2.P.5.1 Specification
4       quality.drug-product.control.analytical Analytical Procedures 3.2.P.5.2 Analytical Procedures
4       quality.drug-product.control.validation Validation of Analytical Procedures 3.2.P.5.3 Validation
4       quality.drug-product.control.batch Batch Analyses 3.2.P.5.4 Batch Analyses
4       quality.drug-product.control.characterisation Characterisation of Impurities 3.2.P.5.5 Characterisation of Impurities
4       quality.drug-product.control.justification Justification of Specification 3.2.P.5.6 Justification
3     quality.drug-product.reference Reference Standards or Materials 3.2.P.6 Reference Standards
3     quality.drug-product.container Container Closure System 3.2.P.7 Container Closure System
3     quality.drug-product.stability Stability 3.2.P.8 Stability
4       quality.drug-product.stability.summary Stability Summary and Conclusions 3.2.P.8.1 Stability Summary
4       quality.drug-product.stability.protocol Post-approval Stability Protocol and Commitment 3.2.P.8.2 Post-approval Protocol
4       quality.drug-product.stability.data Stability Data 3.2.P.8.3 Stability Data
2   quality.appendices Appendices 3.2.A Appendices
3     quality.appendices.facilities Facilities and Equipment 3.2.A.1 Facilities and Equipment
3     quality.appendices.adventitious Adventitious Agents Safety Evaluation 3.2.A.2 Adventitious Agents
3     quality.appendices.novel-excipients Novel Excipients 3.2.A.3 Novel Excipients
2   quality.regional Regional Information 3.3 Regional Information
1 nonclinical Nonclinical Study Reports Module 4 – Nonclinical Study Reports
2   nonclinical.pharmacology Pharmacology 4.2 Pharmacology
3     nonclinical.pharmacology.primary Primary Pharmacodynamics 4.2.1.1 Primary Pharmacodynamics
3     nonclinical.pharmacology.secondary Secondary Pharmacodynamics 4.2.1.2 Secondary Pharmacodynamics
3     nonclinical.pharmacology.safety Safety Pharmacology 4.2.1.3 Safety Pharmacology
3     nonclinical.pharmacology.discussion Pharmacodynamic Drug Interactions 4.2.1.4 Pharmacodynamic Drug Interactions
2   nonclinical.pk Pharmacokinetics 4.2.2 Pharmacokinetics
3     nonclinical.pk.absorption Absorption 4.2.2.1 Absorption
3     nonclinical.pk.distribution Distribution 4.2.2.2 Distribution
3     nonclinical.pk.metabolism Metabolism 4.2.2.3 Metabolism
3     nonclinical.pk.excretion Excretion 4.2.2.4 Excretion
3     nonclinical.pk.interactions PK Drug Interactions 4.2.2.5 PK Drug Interactions
2   nonclinical.toxicology Toxicology 4.2.3 Toxicology
3     nonclinical.toxicology.single Single-Dose Toxicity 4.2.3.1 Single-Dose Toxicity
3     nonclinical.toxicology.repeat Repeat-Dose Toxicity 4.2.3.2 Repeat-Dose Toxicity
3     nonclinical.toxicology.geno Genotoxicity 4.2.3.3 Genotoxicity
4       nonclinical.toxicology.geno.invitro In Vitro 4.2.3.3.1 In Vitro
4       nonclinical.toxicology.geno.invivo In Vivo 4.2.3.3.2 In Vivo
3     nonclinical.toxicology.carc Carcinogenicity 4.2.3.4 Carcinogenicity
3     nonclinical.toxicology.repro Reproductive and Developmental Toxicity 4.2.3.5 Reproductive Toxicity
4       nonclinical.toxicology.repro.fertility Fertility and Early Embryonic Development 4.2.3.5.1 Fertility
4       nonclinical.toxicology.repro.embryo Embryo-Fetal Development 4.2.3.5.2 Embryo-Fetal
4       nonclinical.toxicology.repro.peri Peri- and Post-Natal Development 4.2.3.5.3 Peri-/Post-Natal
3     nonclinical.toxicology.local Local Tolerance 4.2.3.6 Local Tolerance
3     nonclinical.toxicology.other Other Toxicity Studies 4.2.3.7 Other Toxicity Studies
4       nonclinical.toxicology.other.antigenicity Antigenicity 4.2.3.7.1 Antigenicity
4       nonclinical.toxicology.other.immunotox Immunotoxicity 4.2.3.7.2 Immunotoxicity
4       nonclinical.toxicology.other.mechanistic Mechanistic Studies 4.2.3.7.3 Mechanistic
4       nonclinical.toxicology.other.impurities Impurities 4.2.3.7.4 Impurities
4       nonclinical.toxicology.other.metabolites Metabolites 4.2.3.7.5 Metabolites
4       nonclinical.toxicology.other.other Other 4.2.3.7.6 Other
1 clinical Clinical Study Reports Module 5 – Clinical Study Reports
2   clinical.biopharm Biopharmaceutic Studies 5.2 Biopharmaceutic Studies
3     clinical.biopharm.ba-be Bioavailability / Bioequivalence 5.2.1-2 BA/BE Studies
3     clinical.biopharm.invitro In Vitro–In Vivo Correlation 5.2.3 IVIVC
2   clinical.pk Clinical Pharmacology Studies 5.3 Clinical Pharmacology
3     clinical.pk.healthy Studies in Healthy Subjects 5.3.1 Healthy Subjects
3     clinical.pk.patient Studies in Target Population 5.3.2 Target Population
3     clinical.pk.intrinsic Intrinsic Factors 5.3.3 Intrinsic Factors
4       clinical.pk.intrinsic.renal Renal Impairment 5.3.3.1 Renal
4       clinical.pk.intrinsic.hepatic Hepatic Impairment 5.3.3.2 Hepatic
4       clinical.pk.intrinsic.age Age / Pediatric 5.3.3.3 Age/Pediatric
3     clinical.pk.extrinsic Extrinsic Factors 5.3.4 Extrinsic Factors
4       clinical.pk.extrinsic.ddi Drug-Drug Interactions 5.3.4.1 DDI
3     clinical.pk.pop Population PK 5.3.5 Population PK
2   clinical.efficacy Clinical Efficacy & Safety Studies 5.3.5-5.4 Efficacy and Safety
3     clinical.efficacy.controlled Controlled Clinical Studies 5.3.5.1 Controlled Studies
3     clinical.efficacy.uncontrolled Uncontrolled Studies 5.3.5.2 Uncontrolled
3     clinical.efficacy.other Other Studies 5.3.5.3 Other
3     clinical.efficacy.analysis Analyses of Efficacy 5.3.5.4 Analyses
2   clinical.safety Safety Data 5.3.6 Safety
3     clinical.safety.exposure Extent of Exposure 5.3.6.1 Exposure
3     clinical.safety.ae Adverse Events 5.3.6.2 AEs
3     clinical.safety.lab Clinical Laboratory 5.3.6.3 Lab
3     clinical.safety.vital Vital Signs / ECG 5.3.6.4 Vital/ECG
3     clinical.safety.immuno Immunogenicity 5.3.6.5 Immunogenicity
2   clinical.literature Literature References 5.4 Literature References
2   clinical.synopses Synopses of Individual Studies 5.3.7 Synopses