| Clinical | Annual Report | General Investigational Plan |
| Clinical | Annual Report | Individual Study Information |
| Clinical | Annual Report | Status of Other Postmarketing Studies and Requirements |
| Clinical | Annual Report | Summary of Clinical Pharmacology Information |
| Clinical | Annual Report | |
| Clinical | Case Report Forms | |
| Clinical | Image Files | |
| Clinical | Investigational Brochure (IB) | Appendices |
| Clinical | Investigational Brochure (IB) | Investigational Brochure (IB) Binder |
| Clinical | Investigational Brochure (IB) | Main Body |
| Clinical | Investigational Brochure (IB) | Published Report |
| Clinical | Investigational Brochure (IB) | Summary of Changes |
| Clinical | Investigational Brochure (IB) | |
| Clinical | Listings | Abnormal Lab Values Patient Listing |
| Clinical | Listings | Adverse Events Listing |
| Clinical | Listings | Available on Request Listing |
| Clinical | Listings | Compliance and/or Drug Concentration Data Listing |
| Clinical | Listings | Demographic Data Listing |
| Clinical | Listings | Discontinued Patients Listing |
| Clinical | Listings | Individual Efficacy Response Data Listing |
| Clinical | Listings | Individual Laboratory Measurements Listing |
| Clinical | Listings | Patient Data Listing |
| Clinical | Listings | Patients Excluded from the Efficacy Analysis Listing |
| Clinical | Listings | Protocol Deviations Listing |
| Clinical | Listings | |
| Clinical | Regulatory Support | Compliance with Screening Outcomes |
| Clinical | Regulatory Support | Declarations - Statements |
| Clinical | Regulatory Support | Financial and Other Arrangements |
| Clinical | Regulatory Support | Good Clinical Practice (GCP) Compliance |
| Clinical | Regulatory Support | Individual Patient Data - Statement of Availability |
| Clinical | Regulatory Support | Information About the Experts |
| Clinical | Regulatory Support | Information Amendment - Clinical |
| Clinical | Regulatory Support | Investigational Medicinal Product Dossier (IMPD) Clinical Data |
| Clinical | Regulatory Support | List of Studies Conducted with the same Investigational Medicinal Product (IMP) |
| Clinical | Regulatory Support | Modification Description |
| Clinical | Regulatory Support | Opinion of the Ethics Committee (EC) |
| Clinical | Regulatory Support | Overall Benefit-Risk Assessment |
| Clinical | Regulatory Support | Proof of Insurance |
| Clinical | Regulatory Support | Protocol Safety and Efficacy Template (PSEAT) |
| Clinical | Regulatory Support | Special Protocol Assessment Request - Clinical Study |
| Clinical | Regulatory Support | |
| Clinical | Statistics and Data Management | Annotated CRF (aCRF) |
| Clinical | Statistics and Data Management | Annotated ECG Waveform Dataset |
| Clinical | Statistics and Data Management | Data Definition - Analysis Datasets ADaM |
| Clinical | Statistics and Data Management | Data Definition - Analysis Datasets Legacy |
| Clinical | Statistics and Data Management | Data Definition - Bioresearch Monitoring Program (BIMO) |
| Clinical | Statistics and Data Management | Data Definition - Data Tabulations Legacy |
| Clinical | Statistics and Data Management | Data Definition - Data Tabulations SDTM |
| Clinical | Statistics and Data Management | Data Definition - Miscellaneous |
| Clinical | Statistics and Data Management | Data Management Plan |
| Clinical | Statistics and Data Management | Data Monitoring Committee (DMC) |
| Clinical | Statistics and Data Management | Data Monitoring Plan |
| Clinical | Statistics and Data Management | Data on Bioequivalence Studies |
| Clinical | Statistics and Data Management | Dataset - Analysis ADaM |
| Clinical | Statistics and Data Management | Dataset - Analysis Legacy |
| Clinical | Statistics and Data Management | Dataset - Bioresearch Monitoring Program (BIMO) |
| Clinical | Statistics and Data Management | Dataset - Data Tabulation Legacy |
| Clinical | Statistics and Data Management | Dataset - Data Tabulation SDTM |
| Clinical | Statistics and Data Management | Dataset - Miscellaneous |
| Clinical | Statistics and Data Management | List of Patients Receiving Test Drug |
| Clinical | Statistics and Data Management | Program File - Analysis Datasets ADaM |
| Clinical | Statistics and Data Management | Program File - Analysis Datasets Legacy |
| Clinical | Statistics and Data Management | Randomization Scheme |
| Clinical | Statistics and Data Management | Reviewer’s Guide - Analysis Data (ADRG) |
| Clinical | Statistics and Data Management | Reviewer’s Guide - Bioresearch Monitoring Program (BIMO) |
| Clinical | Statistics and Data Management | Reviewer’s Guide - Study Data (CSDRG) |
| Clinical | Statistics and Data Management | Statistical Analysis Plan |
| Clinical | Statistics and Data Management | Statistical Output |
| Clinical | Statistics and Data Management | Subject Profile |
| Clinical | Statistics and Data Management | |
| Clinical | Study Protocol | Full Protocol or Protocol Amendment |
| Clinical | Study Protocol | Protocol Synopsis |
| Clinical | Study Protocol | Study Design |
| Clinical | Study Protocol | Summary of Changes |
| Clinical | Study Protocol | Tracked Changes Version |
| Clinical | Study Protocol | |
| Clinical | Study Report Appendices | Audit Certificates and Reports |
| Clinical | Study Report Appendices | Important Publications Referenced in the Report |
| Clinical | Study Report Appendices | Informed Consent Form (ICF) |
| Clinical | Study Report Appendices | Interlaboratory Standardization Methods |
| Clinical | Study Report Appendices | Investigator CVs |
| Clinical | Study Report Appendices | List and Description of Investigators and Sites |
| Clinical | Study Report Appendices | List of IECs and IRBs |
| Clinical | Study Report Appendices | Publications based on the study |
| Clinical | Study Report Appendices | Sample CRF |
| Clinical | Study Report Appendices | Signature Page |
| Clinical | Study Report Appendices | Statement of Investigator or 1572 |
| Clinical | Study Report Appendices | |
| Clinical | Study Reports | Documentation of Statistical Methods |
| Clinical | Study Reports | Legacy Clinical Study Report |
| Clinical | Study Reports | Microbiology Report |
| Clinical | Study Reports | Patient Narratives |
| Clinical | Study Reports | Postmarketing Description |
| Clinical | Study Reports | Published Study Report |
| Clinical | Study Reports | Report Body |
| Clinical | Study Reports | Study Report Binder |
| Clinical | Study Reports | Supporting Bioavailability/Pharmacokinetic (BA/PK) Report |
| Clinical | Study Reports | Synopsis |
| Clinical | Study Reports | Tables and Figures |
| Clinical | Study Reports | Title Page |
| Clinical | Study Reports | |
| Clinical | Summaries | Clinical Overview |
| Clinical | Summaries | Comparative Bioavailability - Bioequivalence |
| Clinical | Summaries | Comprehensive Summary - Bioequivalence |
| Clinical | Summaries | Integrated Summary of Efficacy (ISE) |
| Clinical | Summaries | Integrated Summary of Immunogenicity |
| Clinical | Summaries | Integrated Summary of Safety (ISS) |
| Clinical | Summaries | List of References |
| Clinical | Summaries | Summary of Bioavailability or Bioequivalence Study |
| Clinical | Summaries | Summary of Biopharmaceutic Studies and Analytical Methods |
| Clinical | Summaries | Summary of Clinical Efficacy |
| Clinical | Summaries | Summary of Clinical Pharmacology Studies |
| Clinical | Summaries | Summary of Clinical Safety |
| Clinical | Summaries | Synopses of Individual Studies |
| Clinical | Summaries | Tabular Listing of All Clinical Studies |
| Clinical | Summaries | |
| Clinical | Table of Contents | |
| Clinical | | |
| IDMP | eAF FHIR Output | |
| IDMP | EU IDMP Submission | |
| IDMP | | |
| Labeling | Carton or Container Label | |
| Labeling | Core Labeling | Company Core Data Sheet (CCDS) |
| Labeling | Core Labeling | Company Core Safety Information (CCSI) |
| Labeling | Core Labeling | Core Instructions for Use (IFU) |
| Labeling | Core Labeling | Core Patient Information |
| Labeling | Core Labeling | Target Product Label (TPL) |
| Labeling | Core Labeling | |
| Labeling | Package Component - Mock-Ups and Specimens | Carton or Container Label - Mock-Up |
| Labeling | Package Component - Mock-Ups and Specimens | Patient Information - Mock-Up |
| Labeling | Package Component - Mock-Ups and Specimens | Prescribing Information - Mock-Up |
| Labeling | Package Component - Mock-Ups and Specimens | Specimen |
| Labeling | Package Component - Mock-Ups and Specimens | |
| Labeling | Product Information | Consumer Medicine Information |
| Labeling | Product Information | Instructions for Use (IFU) |
| Labeling | Product Information | Medication Guide |
| Labeling | Product Information | Patient Information Leaflet (PIL) |
| Labeling | Product Information | Prescribing Information |
| Labeling | Product Information | Prescribing Information - Annotated |
| Labeling | Product Information | Product Information Combined |
| Labeling | Product Information | Product Information Combined - Annotated |
| Labeling | Product Information | Product Monograph |
| Labeling | Product Information | Structured Product Labeling (SPL) |
| Labeling | Product Information | Summary of Product Characteristics (SmPC) |
| Labeling | Product Information | Summary of Product Characteristics (SmPC) Comparison |
| Labeling | Product Information | |
| Labeling | Supporting Labeling Documents | Braille |
| Labeling | Supporting Labeling Documents | Condition of the Authorisation - Annex II |
| Labeling | Supporting Labeling Documents | Label Comprehension Studies |
| Labeling | Supporting Labeling Documents | Labeling Decision Record (LDR) |
| Labeling | Supporting Labeling Documents | Labeling History |
| Labeling | Supporting Labeling Documents | Other Product Information |
| Labeling | Supporting Labeling Documents | Readability Testing Report |
| Labeling | Supporting Labeling Documents | |
| Labeling | | |
| Literature | | |
| Nonclinical | Annual Report | Summary of Nonclinical Studies |
| Nonclinical | Annual Report | |
| Nonclinical | Regulatory Support | Animal Rule |
| Nonclinical | Regulatory Support | Antibiotic Resistance Data |
| Nonclinical | Regulatory Support | Good Laboratory Practice (GLP) Compliance |
| Nonclinical | Regulatory Support | Information About the Experts |
| Nonclinical | Regulatory Support | Information Amendment - Nonclinical |
| Nonclinical | Regulatory Support | Investigational Medicinal Product Dossier (IMPD) Nonclinical Data |
| Nonclinical | Regulatory Support | List of Studies Conducted with the same Investigational Medicinal Product (IMP) |
| Nonclinical | Regulatory Support | Special Protocol Assessment Request - Carcinogenicity Study |
| Nonclinical | Regulatory Support | |
| Nonclinical | Statistics and Data Management | Analysis ADAM Program |
| Nonclinical | Statistics and Data Management | Analysis Dataset |
| Nonclinical | Statistics and Data Management | Analysis Definition |
| Nonclinical | Statistics and Data Management | Analysis Legacy Data Definition |
| Nonclinical | Statistics and Data Management | Analysis Legacy Dataset |
| Nonclinical | Statistics and Data Management | Analysis Legacy Program |
| Nonclinical | Statistics and Data Management | Data Tabulation Data SEND Definition |
| Nonclinical | Statistics and Data Management | Legacy Data Tabulation Dataset |
| Nonclinical | Statistics and Data Management | Legacy Tabulation Definition - Nonclinical |
| Nonclinical | Statistics and Data Management | Miscellaneous Data Definition |
| Nonclinical | Statistics and Data Management | Miscellaneous Dataset |
| Nonclinical | Statistics and Data Management | Reviewer’s Guide - Study Data (NSDRG) |
| Nonclinical | Statistics and Data Management | SEND Data Tabulation Dataset |
| Nonclinical | Statistics and Data Management | |
| Nonclinical | Study Protocol | Full Protocol or Protocol Amendment |
| Nonclinical | Study Protocol | |
| Nonclinical | Study Reports | Appendices |
| Nonclinical | Study Reports | Audit Certificates Report |
| Nonclinical | Study Reports | Compliance and Drug Concentration Data |
| Nonclinical | Study Reports | Final Study Report |
| Nonclinical | Study Reports | Inter-Laboratory Standardisation Methods Quality Assurance |
| Nonclinical | Study Reports | Investigator Signatures |
| Nonclinical | Study Reports | Publications Based on Study |
| Nonclinical | Study Reports | Publications Referenced in Report |
| Nonclinical | Study Reports | Statistical Methods Interim Analysis Plan |
| Nonclinical | Study Reports | Study Report Binder |
| Nonclinical | Study Reports | Study Report Body |
| Nonclinical | Study Reports | Synopsis |
| Nonclinical | Study Reports | Tables, Figures, and Listings |
| Nonclinical | Study Reports | |
| Nonclinical | Summaries | Introduction |
| Nonclinical | Summaries | Nonclinical Overview |
| Nonclinical | Summaries | Pharmacokinetic Tabulated Summary |
| Nonclinical | Summaries | Pharmacokinetic Written Summary |
| Nonclinical | Summaries | Pharmacology Tabulated Summary |
| Nonclinical | Summaries | Pharmacology Written Summary |
| Nonclinical | Summaries | Toxicology Tabulated Summary |
| Nonclinical | Summaries | Toxicology Written Summary |
| Nonclinical | Summaries | |
| Nonclinical | Table of Contents | |
| Nonclinical | | |
| Pharmacovigilance | Annual Report | Summary of Safety Information |
| Pharmacovigilance | Annual Report | |
| Pharmacovigilance | Country Specific Periodic Reports / Line Listings | Line Listing |
| Pharmacovigilance | Country Specific Periodic Reports / Line Listings | Periodic Report |
| Pharmacovigilance | Country Specific Periodic Reports / Line Listings | |
| Pharmacovigilance | Development Safety Update Report (DSUR) | Appendices |
| Pharmacovigilance | Development Safety Update Report (DSUR) | Line Listings of Serious Adverse Reactions |
| Pharmacovigilance | Development Safety Update Report (DSUR) | List of Subjects who Died During the Reporting Period |
| Pharmacovigilance | Development Safety Update Report (DSUR) | List of Subjects who Dropped Out of Studies During the Reporting Period |
| Pharmacovigilance | Development Safety Update Report (DSUR) | Published Report |
| Pharmacovigilance | Development Safety Update Report (DSUR) | Report Binder |
| Pharmacovigilance | Development Safety Update Report (DSUR) | Report Body |
| Pharmacovigilance | Development Safety Update Report (DSUR) | Summary |
| Pharmacovigilance | Development Safety Update Report (DSUR) | Title Page |
| Pharmacovigilance | Development Safety Update Report (DSUR) | |
| Pharmacovigilance | Individual Case Safety Report | ICSR Cover Letter |
| Pharmacovigilance | Individual Case Safety Report | Report |
| Pharmacovigilance | Individual Case Safety Report | |
| Pharmacovigilance | Periodic Adverse Experience Report (PAER / PADER) | Appendices |
| Pharmacovigilance | Periodic Adverse Experience Report (PAER / PADER) | Published Report |
| Pharmacovigilance | Periodic Adverse Experience Report (PAER / PADER) | Report Binder |
| Pharmacovigilance | Periodic Adverse Experience Report (PAER / PADER) | Report Body |
| Pharmacovigilance | Periodic Adverse Experience Report (PAER / PADER) | |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | Cumulative Summary Tabulation of Serious Adverse Events from Clinical Trials |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | Interval and Cumulative Summary Tabulations from Marketed Experience |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | List of the Sources of Information Used to Prepare the PBRER |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | Listing of Interventional Studies with a Primary Objective of Post-Authorization Safety Monitoring |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | Listing of Non-Interventional Studies with a Primary Objective of Post-Authorization Safety Monitoring |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | Published Report |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | Reference Information |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | Report Binder |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | Report Body |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | Summary |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | Tabular Summary of Safety Signals |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | Title Page |
| Pharmacovigilance | Periodic Benefit-Risk Evaluation or Safety Update Report (PBRER / PSUR) | |
| Pharmacovigilance | Regulatory Support | Good Pharmacovigilance Practice (GPP) Compliance |
| Pharmacovigilance | Regulatory Support | Information Related to the Qualified Person Responsible for Pharmacovigilance (QPPV) |
| Pharmacovigilance | Regulatory Support | Other Pharmacovigilance Information |
| Pharmacovigilance | Regulatory Support | Risk Communication |
| Pharmacovigilance | Regulatory Support | |
| Pharmacovigilance | Risk Evaluation and Mitigation Strategies (REMS) | Assessment Methodology |
| Pharmacovigilance | Risk Evaluation and Mitigation Strategies (REMS) | Draft REMS |
| Pharmacovigilance | Risk Evaluation and Mitigation Strategies (REMS) | Final Assessment Report |
| Pharmacovigilance | Risk Evaluation and Mitigation Strategies (REMS) | Final REMS |
| Pharmacovigilance | Risk Evaluation and Mitigation Strategies (REMS) | Modification History |
| Pharmacovigilance | Risk Evaluation and Mitigation Strategies (REMS) | Related Documents |
| Pharmacovigilance | Risk Evaluation and Mitigation Strategies (REMS) | Report Binder |
| Pharmacovigilance | Risk Evaluation and Mitigation Strategies (REMS) | |
| Pharmacovigilance | Risk Management Plan | Additional Risk Minimization Measures (aRMM) |
| Pharmacovigilance | Risk Management Plan | Appendices |
| Pharmacovigilance | Risk Management Plan | Implementation Plan (for aRMMs) |
| Pharmacovigilance | Risk Management Plan | Post-Marketing Surveillance |
| Pharmacovigilance | Risk Management Plan | Published Report |
| Pharmacovigilance | Risk Management Plan | Related Documents |
| Pharmacovigilance | Risk Management Plan | Report Binder |
| Pharmacovigilance | Risk Management Plan | |
| Pharmacovigilance | Safety Management Plan (SMP) | Safety Management Plan Protocol (SMP) |
| Pharmacovigilance | Safety Management Plan (SMP) | |
| Pharmacovigilance | Table of Contents | |
| Pharmacovigilance | | |
| Quality | Adventitious Agents Safety Evaluation | |
| Quality | Annual Report | Summary of Manufacturing Changes |
| Quality | Annual Report | Summary of Microbiological Changes |
| Quality | Annual Report | |
| Quality | Characterization of Drug Substance | Elucidation of Structure and Characteristics |
| Quality | Characterization of Drug Substance | Impurities |
| Quality | Characterization of Drug Substance | |
| Quality | Comparability Protocols for Drug Product | |
| Quality | Comparability Protocols for Drug Substance | |
| Quality | Container Closure Systems for Drug Product | |
| Quality | Container Closure Systems for Drug Substance | |
| Quality | Control of Drug Product | Analytical Procedures |
| Quality | Control of Drug Product | Batch Analyses |
| Quality | Control of Drug Product | Characterization of Impurities |
| Quality | Control of Drug Product | Justification of Specifications |
| Quality | Control of Drug Product | Specifications |
| Quality | Control of Drug Product | Validation of Analytical Procedures |
| Quality | Control of Drug Product | |
| Quality | Control of Drug Substance | Analytical Procedures |
| Quality | Control of Drug Substance | Batch Analyses |
| Quality | Control of Drug Substance | Justification of Specifications |
| Quality | Control of Drug Substance | Specifications |
| Quality | Control of Drug Substance | Validation of Analytical Procedures |
| Quality | Control of Drug Substance | |
| Quality | Control of Excipients | Analytical Procedures |
| Quality | Control of Excipients | Certificate of Analysis (CoA) |
| Quality | Control of Excipients | Control of Excipients (Consolidated) |
| Quality | Control of Excipients | Excipients of Human or Animal Origin |
| Quality | Control of Excipients | Justification of Specifications |
| Quality | Control of Excipients | Novel Excipients |
| Quality | Control of Excipients | Specifications |
| Quality | Control of Excipients | Validation of Analytical Procedures |
| Quality | Control of Excipients | |
| Quality | Description and Composition of the Drug Product | |
| Quality | Drug Master Files for Drug Product | |
| Quality | Drug Master Files for Drug Substance | |
| Quality | Drug Product Stability | Post-Approval Stability Protocol and Stability Commitment |
| Quality | Drug Product Stability | Stability Data |
| Quality | Drug Product Stability | Stability Summary and Conclusions |
| Quality | Drug Product Stability | |
| Quality | Drug Substance Stability | Post-Approval Stability Protocol and Stability Commitment |
| Quality | Drug Substance Stability | Stability Data |
| Quality | Drug Substance Stability | Stability Summary and Conclusions |
| Quality | Drug Substance Stability | |
| Quality | Facilities and Equipment | Establishment Licensing |
| Quality | Facilities and Equipment | Facilities and Equipment Overview |
| Quality | Facilities and Equipment | Facilities Diagrams |
| Quality | Facilities and Equipment | Manufacturing Site Documents (MSD) |
| Quality | Facilities and Equipment | |
| Quality | General Information about the Drug Substance | General Properties |
| Quality | General Information about the Drug Substance | Nomenclature |
| Quality | General Information about the Drug Substance | Structure |
| Quality | General Information about the Drug Substance | |
| Quality | Manufacture of Drug Product | Batch Formula |
| Quality | Manufacture of Drug Product | Certificate of Analysis (CoA) |
| Quality | Manufacture of Drug Product | Controls of Critical Steps and Intermediates |
| Quality | Manufacture of Drug Product | Description of Manufacturing Process and Process Controls |
| Quality | Manufacture of Drug Product | Executed Production Record |
| Quality | Manufacture of Drug Product | Manufacturers |
| Quality | Manufacture of Drug Product | Process Validation and/or Evaluation |
| Quality | Manufacture of Drug Product | |
| Quality | Manufacture of Drug Substance | Cell Bank Testing |
| Quality | Manufacture of Drug Substance | Cell Line Development |
| Quality | Manufacture of Drug Substance | Certificate of Analysis (CoA) |
| Quality | Manufacture of Drug Substance | Control of Materials |
| Quality | Manufacture of Drug Substance | Controls of Critical Steps and Intermediates |
| Quality | Manufacture of Drug Substance | Description of Manufacturing Process and Process Controls |
| Quality | Manufacture of Drug Substance | Executed Production Record |
| Quality | Manufacture of Drug Substance | Manufacturers |
| Quality | Manufacture of Drug Substance | Manufacturing Process Development |
| Quality | Manufacture of Drug Substance | Process Validation and/or Evaluation |
| Quality | Manufacture of Drug Substance | |
| Quality | Pharmaceutical Development of the Drug Product | Compatibility |
| Quality | Pharmaceutical Development of the Drug Product | Components of Drug Product |
| Quality | Pharmaceutical Development of the Drug Product | Container Closure System |
| Quality | Pharmaceutical Development of the Drug Product | Drug Product |
| Quality | Pharmaceutical Development of the Drug Product | Manufacturing Process Development |
| Quality | Pharmaceutical Development of the Drug Product | Microbiological Attributes |
| Quality | Pharmaceutical Development of the Drug Product | Pharmaceutical Development of the Drug Product (Consolidated) |
| Quality | Pharmaceutical Development of the Drug Product | |
| Quality | Quality Overall Summary | Appendices |
| Quality | Quality Overall Summary | Drug Product Summary |
| Quality | Quality Overall Summary | Drug Substance Summary |
| Quality | Quality Overall Summary | Introduction |
| Quality | Quality Overall Summary | Quality Overall Summary (Consolidated) |
| Quality | Quality Overall Summary | Regional Information Summary / Overview |
| Quality | Quality Overall Summary | |
| Quality | Reference Standards or Materials for Drug Product | |
| Quality | Reference Standards or Materials for Drug Substance | |
| Quality | Regional Information | Alcohol Content Declaration |
| Quality | Regional Information | Assessment of Similarity |
| Quality | Regional Information | Batch Records (Master/Executed) |
| Quality | Regional Information | Certified Product Details |
| Quality | Regional Information | Comparability Protocols |
| Quality | Regional Information | Diluents and Coloring Agents in the Product Formula |
| Quality | Regional Information | Information on Batches used in Nonclinical and Clinical Studies |
| Quality | Regional Information | Lot Release |
| Quality | Regional Information | Materials of Animal and/or Human Origin |
| Quality | Regional Information | Medical Device |
| Quality | Regional Information | Method Validation Package |
| Quality | Regional Information | Multiple API Manufacturers |
| Quality | Regional Information | On Site Evaluation |
| Quality | Regional Information | Parent API Manufacturer with Various Sites |
| Quality | Regional Information | Pharmaceutical and Biological Availability |
| Quality | Regional Information | Porcine - Pork Declaration |
| Quality | Regional Information | Process Validation Scheme for the Drug Product |
| Quality | Regional Information | Regional Information (Consolidated) |
| Quality | Regional Information | Sample Information |
| Quality | Regional Information | Statistician’s Package |
| Quality | Regional Information | Supplier’s Compliance with Packaging and Colouring Standards |
| Quality | Regional Information | Yearly Biologic Product Report (YBPR) |
| Quality | Regional Information | |
| Quality | Regulatory Support | Annexes - Manufacturing |
| Quality | Regulatory Support | API Change Control |
| Quality | Regulatory Support | Certificate - Ph. Eur. Suitability (CEP) |
| Quality | Regulatory Support | Certificate - Pharmaceutical Product (CPP) |
| Quality | Regulatory Support | Certificate - Plasma Master File (PMF) |
| Quality | Regulatory Support | Certificate - Vaccine Antigen Master File (VAMF) |
| Quality | Regulatory Support | Comparison of Generic Drug and Reference Listed Drug |
| Quality | Regulatory Support | Data Verification |
| Quality | Regulatory Support | DMF - ASMF Authorization - Reference Letter |
| Quality | Regulatory Support | Environmental Risk Assessment |
| Quality | Regulatory Support | Flow-Chart of Manufacturing Process |
| Quality | Regulatory Support | Genetically Modified Organism (GMO) Assessment |
| Quality | Regulatory Support | Good Manufacturing Practice (GMP) Compliance |
| Quality | Regulatory Support | Import and Export Information |
| Quality | Regulatory Support | Information About the Experts |
| Quality | Regulatory Support | Information Amendment - Quality |
| Quality | Regulatory Support | Investigational Medicinal Product Dossier (IMPD) Quality Consolidated |
| Quality | Regulatory Support | Investigational Medicinal Product Dossier (IMPD) Summary of Changes |
| Quality | Regulatory Support | Investigational Medicinal Product Dossier (IMPD) Tracked Changes |
| Quality | Regulatory Support | Manufacturer Qualification Documents |
| Quality | Regulatory Support | Manufacturing Authorization |
| Quality | Regulatory Support | Non-Investigational Medicinal Products Used in Trial |
| Quality | Regulatory Support | Pharmacy Manual |
| Quality | Regulatory Support | Qualified Person (QP) Declaration |
| Quality | Regulatory Support | Special Protocol Assessment Request - Stability Study |
| Quality | Regulatory Support | Statement - Non-Animal Sourced Materials |
| Quality | Regulatory Support | Statement - Right of Reference |
| Quality | Regulatory Support | |
| Quality | Solvents for Reconstitution and Diluents | |
| Quality | Table of Contents | |
| Quality | | |
| Regulatory | Accelerated and Priority Review | Correspondence Regarding Accelerated and Priority Review |
| Regulatory | Accelerated and Priority Review | Emergency Use Authorization (EUA) Information |
| Regulatory | Accelerated and Priority Review | Fast Track Status Decision |
| Regulatory | Accelerated and Priority Review | Other Application for Accelerated Review Designation |
| Regulatory | Accelerated and Priority Review | Request - Breakthrough Therapy Designation |
| Regulatory | Accelerated and Priority Review | Request - Fast Track Designation |
| Regulatory | Accelerated and Priority Review | Request - Priority Review |
| Regulatory | Accelerated and Priority Review | Request - Rolling Review |
| Regulatory | Accelerated and Priority Review | Tropical Disease Priority Review Voucher |
| Regulatory | Accelerated and Priority Review | Withdrawal Request - Fast Track Designation |
| Regulatory | Accelerated and Priority Review | |
| Regulatory | Administrative Information | Additional Data - Information |
| Regulatory | Administrative Information | Annexes - Other |
| Regulatory | Administrative Information | Approval Application (Copy) |
| Regulatory | Administrative Information | ATC Product Code Submission |
| Regulatory | Administrative Information | Background of Origin - Discovery of Development |
| Regulatory | Administrative Information | Checklist Form - Self Assessment Report |
| Regulatory | Administrative Information | Comparison Table |
| Regulatory | Administrative Information | Compassionate Use |
| Regulatory | Administrative Information | Confirmation of Contract |
| Regulatory | Administrative Information | Cover Letter |
| Regulatory | Administrative Information | Cross Reference to Previously Submitted Information |
| Regulatory | Administrative Information | Dispute Resolution Information |
| Regulatory | Administrative Information | Field Alert Reports |
| Regulatory | Administrative Information | General Note to Reviewer |
| Regulatory | Administrative Information | Information on Development Studies |
| Regulatory | Administrative Information | Justification for Not Providing Biopharmaceutic Studies |
| Regulatory | Administrative Information | Labeling Exemption |
| Regulatory | Administrative Information | Lifecycle Management Tracking Table |
| Regulatory | Administrative Information | List of Attached Documents |
| Regulatory | Administrative Information | List of Authorized to Persons to Incorporate by Reference |
| Regulatory | Administrative Information | List of Similar Products |
| Regulatory | Administrative Information | Other Administrative Information |
| Regulatory | Administrative Information | Other Documents on Previously Approved Drugs |
| Regulatory | Administrative Information | Power of Attorney |
| Regulatory | Administrative Information | Pricing Information |
| Regulatory | Administrative Information | Proof of Delivery |
| Regulatory | Administrative Information | Registration Status |
| Regulatory | Administrative Information | Request for Waiver - In Vivo Bioavailability Studies |
| Regulatory | Administrative Information | Request for Waiver - In Vivo Studies |
| Regulatory | Administrative Information | Request for Waiver - Other |
| Regulatory | Administrative Information | Table of Contents |
| Regulatory | Administrative Information | Template of Database Entering |
| Regulatory | Administrative Information | |
| Regulatory | Annual Report | Distribution Data |
| Regulatory | Annual Report | Foreign Marketing |
| Regulatory | Annual Report | IND or NDA Annual Report (Consolidated) |
| Regulatory | Annual Report | Log of Outstanding Regulatory Business |
| Regulatory | Annual Report | Status of Postmarketing Study Commitments and Requirements |
| Regulatory | Annual Report | Summary of Labeling Changes |
| Regulatory | Annual Report | Summary of Other Significant New Information |
| Regulatory | Annual Report | |
| Regulatory | Application Forms | Form - Application |
| Regulatory | Application Forms | Form - Application Annex |
| Regulatory | Application Forms | Form - Certification and Attestation |
| Regulatory | Application Forms | Form - Declaration Radiopharmaceuticals |
| Regulatory | Application Forms | Form - Drug Master File (DMF) |
| Regulatory | Application Forms | Form - EudraCT |
| Regulatory | Application Forms | Form - Fee |
| Regulatory | Application Forms | Form - Full Declaration |
| Regulatory | Application Forms | Form - Manufacturer Information |
| Regulatory | Application Forms | Form - Other |
| Regulatory | Application Forms | Form - Periodic Report - PSUR - PBRER |
| Regulatory | Application Forms | Form - Pharmaceutical Information for Parenteral Preparations |
| Regulatory | Application Forms | Form - Renewal |
| Regulatory | Application Forms | Form - Specimen Submission |
| Regulatory | Application Forms | Form - Status Marketing Authorisations Abroad |
| Regulatory | Application Forms | Form - Variation |
| Regulatory | Application Forms | Form 1571 |
| Regulatory | Application Forms | Form 2252 |
| Regulatory | Application Forms | Form 2253 |
| Regulatory | Application Forms | Form 2567 |
| Regulatory | Application Forms | Form 3397 |
| Regulatory | Application Forms | Form 356h |
| Regulatory | Application Forms | Form 3674 |
| Regulatory | Application Forms | Form 3792 |
| Regulatory | Application Forms | Form 3794 |
| Regulatory | Application Forms | Form 3938 |
| Regulatory | Application Forms | Form 3988 |
| Regulatory | Application Forms | Proof of Payment |
| Regulatory | Application Forms | Regulatory Enrolment (REP) - Company Template (CO) |
| Regulatory | Application Forms | Regulatory Enrolment (REP) - Product Information Template (PI) |
| Regulatory | Application Forms | Regulatory Enrolment (REP) - Regulatory Transaction Template (RT) |
| Regulatory | Application Forms | Signature Page |
| Regulatory | Application Forms | |
| Regulatory | Application Status | Request - Inactivation |
| Regulatory | Application Status | Request - Reactivation |
| Regulatory | Application Status | Request - Reconsideration Documentation |
| Regulatory | Application Status | Request - Reinstatement |
| Regulatory | Application Status | Withdrawal Request - Investigational Application |
| Regulatory | Application Status | Withdrawal Request - Listed Drug (Generic) |
| Regulatory | Application Status | Withdrawal Request - Marketed Product |
| Regulatory | Application Status | Withdrawal Request - Other |
| Regulatory | Application Status | Withdrawal Request - Unapproved Marketing Application |
| Regulatory | Application Status | |
| Regulatory | Authorizations - Declarations - Statements | Authorisation - EU-EFTA |
| Regulatory | Authorizations - Declarations - Statements | Authorization - Letter |
| Regulatory | Authorizations - Declarations - Statements | Authorization - Sharing Information |
| Regulatory | Authorizations - Declarations - Statements | Declaration - Applicant |
| Regulatory | Authorizations - Declarations - Statements | Declaration - Authenticity |
| Regulatory | Authorizations - Declarations - Statements | Declaration - Co-Marketed Medicines |
| Regulatory | Authorizations - Declarations - Statements | Declaration - Electronic Copy |
| Regulatory | Authorizations - Declarations - Statements | Statement - Basis for Submission |
| Regulatory | Authorizations - Declarations - Statements | Statement - Generic Drug Enforcement Act |
| Regulatory | Authorizations - Declarations - Statements | Statement - Other |
| Regulatory | Authorizations - Declarations - Statements | |
| Regulatory | Certificates and Certifications | Certificate - Legal Registration |
| Regulatory | Certificates and Certifications | Certificate - Medical Device Approval |
| Regulatory | Certificates and Certifications | Certificate - Other |
| Regulatory | Certificates and Certifications | Certification - Applicant - MAH |
| Regulatory | Certificates and Certifications | Certification - Approvals |
| Regulatory | Certificates and Certifications | Certification - Commissioned Research |
| Regulatory | Certificates and Certifications | Certification - Debarment |
| Regulatory | Certificates and Certifications | Certification - Drug Quality and Safety |
| Regulatory | Certificates and Certifications | Certification - Enterprises |
| Regulatory | Certificates and Certifications | Certification - Field Copy |
| Regulatory | Certificates and Certifications | Certification - Financial Certification and Disclosure Information |
| Regulatory | Certificates and Certifications | Certification - Lawful Source |
| Regulatory | Certificates and Certifications | Certification - Other |
| Regulatory | Certificates and Certifications | Certification - Qualification |
| Regulatory | Certificates and Certifications | Certification - Registrar of Companies |
| Regulatory | Certificates and Certifications | Certification - Registration |
| Regulatory | Certificates and Certifications | Certification - South African Pharmacy Council (SAPC) Registration |
| Regulatory | Certificates and Certifications | |
| Regulatory | Clinical Trial Information | Certifications of Clinical Trials |
| Regulatory | Clinical Trial Information | Declaration of the End of Trial Form |
| Regulatory | Clinical Trial Information | Diversity Plan |
| Regulatory | Clinical Trial Information | EudraCT Number Confirmation |
| Regulatory | Clinical Trial Information | Form - Clinical Trial Site Information |
| Regulatory | Clinical Trial Information | Information on Prior-Related Clinical Applications |
| Regulatory | Clinical Trial Information | Information Related to Clinical Trials |
| Regulatory | Clinical Trial Information | Investigational Carton and Container Labels |
| Regulatory | Clinical Trial Information | Investigational Labeling |
| Regulatory | Clinical Trial Information | Lay Summary |
| Regulatory | Clinical Trial Information | Notice of Compliance (NOC) with Conditions |
| Regulatory | Clinical Trial Information | Notification of Discontinuation of Clinical Trial |
| Regulatory | Clinical Trial Information | Potential Safety Risk |
| Regulatory | Clinical Trial Information | Reference Product Label |
| Regulatory | Clinical Trial Information | Request to Charge for Clinical Trial |
| Regulatory | Clinical Trial Information | Request to Charge for Expanded Access |
| Regulatory | Clinical Trial Information | |
| Regulatory | Contact - Sponsor - Applicant Information | Change in Contact - Agent |
| Regulatory | Contact - Sponsor - Applicant Information | Change of Address |
| Regulatory | Contact - Sponsor - Applicant Information | Change of Ownership |
| Regulatory | Contact - Sponsor - Applicant Information | Change of Sponsor - MAH |
| Regulatory | Contact - Sponsor - Applicant Information | Proposed Holder of Certificate of Registration (PHCR) |
| Regulatory | Contact - Sponsor - Applicant Information | Transfer of Obligation |
| Regulatory | Contact - Sponsor - Applicant Information | |
| Regulatory | Correspondence | Acknowledgement of Receipt |
| Regulatory | Correspondence | Agency Decisions |
| Regulatory | Correspondence | Approval Letter |
| Regulatory | Correspondence | From Health Authority |
| Regulatory | Correspondence | Health Authority Advice |
| Regulatory | Correspondence | Meeting Correspondence |
| Regulatory | Correspondence | Meeting Granted Letter |
| Regulatory | Correspondence | Other Correspondence |
| Regulatory | Correspondence | Record of Contact |
| Regulatory | Correspondence | Request for Information |
| Regulatory | Correspondence | To Health Authority |
| Regulatory | Correspondence | |
| Regulatory | Data Submission | IDMP FHIR Message |
| Regulatory | Data Submission | |
| Regulatory | Emergency Care Research | Correspondence Regarding Emergency Care Research |
| Regulatory | Emergency Care Research | Exemption from Informed Consent for Emergency Care Research |
| Regulatory | Emergency Care Research | Public Disclosure Statement for Emergency Care Research |
| Regulatory | Emergency Care Research | |
| Regulatory | Foreign Regulatory Information | Data Similarities and Differences |
| Regulatory | Foreign Regulatory Information | Documents on Usage Status Abroad |
| Regulatory | Foreign Regulatory Information | Foreign Evaluation Reports |
| Regulatory | Foreign Regulatory Information | Foreign Regulatory Status |
| Regulatory | Foreign Regulatory Information | International Information |
| Regulatory | Foreign Regulatory Information | |
| Regulatory | Health Authority Interactions | Commitments Master List |
| Regulatory | Health Authority Interactions | Health Authority Questions Master List |
| Regulatory | Health Authority Interactions | |
| Regulatory | Investigational Medicinal Product Dossier (IMPD) Published | |
| Regulatory | Meeting Materials and Pre-Submission Details | Background Materials |
| Regulatory | Meeting Materials and Pre-Submission Details | Compliance with Meeting and Pre-Submission Processes |
| Regulatory | Meeting Materials and Pre-Submission Details | Compliance with Pre-Submission Planning Form and Letter |
| Regulatory | Meeting Materials and Pre-Submission Details | Details of Additional Data to be Submitted |
| Regulatory | Meeting Materials and Pre-Submission Details | Meeting Request |
| Regulatory | Meeting Materials and Pre-Submission Details | Pre-Submission Details |
| Regulatory | Meeting Materials and Pre-Submission Details | Sponsor Meeting Minutes |
| Regulatory | Meeting Materials and Pre-Submission Details | |
| Regulatory | Multidisciplinary Information | Information Amendment - Multiple Module |
| Regulatory | Multidisciplinary Information | Multidisciplinary Tabular Summaries |
| Regulatory | Multidisciplinary Information | |
| Regulatory | Orphan Drug Information | Form - Application for Recognition of Orphan Drug Status |
| Regulatory | Orphan Drug Information | Orphan Drug Designation |
| Regulatory | Orphan Drug Information | Orphan Drug Status - Decision |
| Regulatory | Orphan Drug Information | Orphan Market Exclusivity |
| Regulatory | Orphan Drug Information | Orphan Market Exclusivity - Similarity |
| Regulatory | Orphan Drug Information | |
| Regulatory | Patent and Exclusivity Information | Data Protection Information |
| Regulatory | Patent and Exclusivity Information | Exclusivity Claim |
| Regulatory | Patent and Exclusivity Information | Extended Data - Market Exclusivity |
| Regulatory | Patent and Exclusivity Information | Patent Information and Certification |
| Regulatory | Patent and Exclusivity Information | |
| Regulatory | Pediatric (Paediatric) Information | Correspondence Regarding Pediatric Exclusivity or Study Plans |
| Regulatory | Pediatric (Paediatric) Information | Information Related to Pediatrics (Paediatrics) |
| Regulatory | Pediatric (Paediatric) Information | Paediatric Investigation Plan (PIP) - Pediatric Study Plan (PSP) |
| Regulatory | Pediatric (Paediatric) Information | Request - Deferral of Pediatric Studies |
| Regulatory | Pediatric (Paediatric) Information | Request - Pediatric Exclusivity Determination |
| Regulatory | Pediatric (Paediatric) Information | Request - Proposed Pediatric Study and Amendments |
| Regulatory | Pediatric (Paediatric) Information | Request - Waiver of Pediatric Studies |
| Regulatory | Pediatric (Paediatric) Information | |
| Regulatory | Post-Authorization Information | Other Post-Approval Information |
| Regulatory | Post-Authorization Information | Post-Approval CMC Changes |
| Regulatory | Post-Authorization Information | Post-Approval Labeling Changes |
| Regulatory | Post-Authorization Information | Post-Marketing Studies |
| Regulatory | Post-Authorization Information | |
| Regulatory | Product Name Information | Documents about Japanese Accepted Names for Pharmaceuticals |
| Regulatory | Product Name Information | Look-alike/Sound-alike Assessment |
| Regulatory | Product Name Information | Nomenclature Certification of Product Common Name |
| Regulatory | Product Name Information | Nonproprietary Name Information (INN) |
| Regulatory | Product Name Information | Proprietary Name Information |
| Regulatory | Product Name Information | Trade Name Declaration |
| Regulatory | Product Name Information | Trademark Information |
| Regulatory | Product Name Information | |
| Regulatory | Promotional Materials | Annotated Label |
| Regulatory | Promotional Materials | Annotated Material |
| Regulatory | Promotional Materials | Annotated Reference |
| Regulatory | Promotional Materials | Clean Material |
| Regulatory | Promotional Materials | Pre-dissemination Review of Television Ads |
| Regulatory | Promotional Materials | Presubmission Accelerated Launch Materials |
| Regulatory | Promotional Materials | Presubmission Accelerated Non-Launch Materials |
| Regulatory | Promotional Materials | Promotional 2253 Materials |
| Regulatory | Promotional Materials | Request for Advisory Comments on Launch Materials |
| Regulatory | Promotional Materials | Request for Advisory Comments on Non-Launch Materials |
| Regulatory | Promotional Materials | |
| Regulatory | Request for Comments and Advice | Request for Comments and Advice - Other |
| Regulatory | Request for Comments and Advice | Request for Scientific Advice |
| Regulatory | Request for Comments and Advice | |
| Regulatory | Response to Questions and Request for Information | Response to Questions (RTQ) |
| Regulatory | Response to Questions and Request for Information | Response to Request for Information (RFI) |
| Regulatory | Response to Questions and Request for Information | |
| Regulatory | Specific Requirements for Different Types of Applications | Combination Medicine Consent |
| Regulatory | Specific Requirements for Different Types of Applications | Conditional Marketing Authorisation |
| Regulatory | Specific Requirements for Different Types of Applications | Exceptional Circumstances |
| Regulatory | Specific Requirements for Different Types of Applications | Information for Bibliographical (Literature) Based Applications |
| Regulatory | Specific Requirements for Different Types of Applications | Information for Generic - Hybrid - Bio-Similar Applications |
| Regulatory | Specific Requirements for Different Types of Applications | Medicines Register Details |
| Regulatory | Specific Requirements for Different Types of Applications | OTC Product Assurances |
| Regulatory | Specific Requirements for Different Types of Applications | Summaries of Designated Reviews on Poisonous - Deleterious Drugs |
| Regulatory | Specific Requirements for Different Types of Applications | Umbrella Brand Assessment |
| Regulatory | Specific Requirements for Different Types of Applications | |
| Regulatory | Summary Introduction | |
| Regulatory | Translation Acknowledgements or Certificates | |
| Regulatory | | |
| Staged | | |
| Submission Ready | Clinical Study | |
| Submission Ready | Nonclinical Study | |
| Submission Ready | Report | |
| Submission Ready | | |
| Submissions | | |
| Submissions Archive | Content | |
| Submissions Archive | Structure | |
| Submissions Archive | | |
| Templates | | |
| UDI | UDI Submission | |
| UDI | | |
| Unclassified | | |
