Cheiron backend test console

CTD Sections

CTD Pipeline

Curate which regulatory documents govern each CTD section. Add or remove CTD codes per document identity; every edit re-projects onto the document catalogue.

Add or edit an assignment

Assignments(106)

Document	CTD sections
Qualification of non-mutagenic impurities - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-qualification-non-mutagenic-impurities_en.pdf	3.2.S.3 3.2.P.5
Quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-non-clinical-and-clinical-aspects-live-recombinant-viral-vectored-vaccines_en.pdf	3.2.S.2 3.2.S.4 3.2.A.2
Development and manufacture of synthetic peptides - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-manufacture-synthetic-peptides_en.pdf	3.2.S.2 3.2.S.3 3.2.S.4
Pharmaceutical development of medicines for paediatric use - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmaceutical-development-medicines-paediatric-use_en.pdf	3.2.P.2
Use of Artificial Intelligence (AI) in the medicinal product lifecycle - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle_en.pdf	GMP-QMS
Quality of water for pharmaceutical use - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-water-pharmaceutical-use_en.pdf	3.2.P.3 3.2.A.1
Radiopharmaceuticals - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-radiopharmaceuticals-revision-1_en.pdf	3.2.P.3 3.2.P.5
Quality documentation for medicinal products when used with a medical device - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-documentation-medicinal-products-when-used-medical-device-first-version_en.pdf	3.2.P.7 3.2.R
Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-non-clinical-and-clinical-aspects-medicinal-products-containing-genetically-modified-cells-revision-1_en.pdf	3.2.S.2 3.2.S.3 3.2.A.2
Development of a guideline on the quality aspects of mRNA vaccines - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-aspects-mrna-vaccines_en.pdf	3.2.S.2 3.2.S.4 3.2.P.2
In-use stability testing of human medicinal products - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-use-stability-testing-human-medicinal-products_en.pdf	3.2.S.7 3.2.P.8
Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/questions-answers-data-requirements-when-transitioning-low-global-warming-potential-lgwp-propellants-oral-pressurised-metered-dose-inhalers_en.pdf	3.2.P.2 3.2.R M5
Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different-medicinal-products-shared-facilities_en.pdf	3.2.P.3 3.2.A.1 GMP-QMS
Non-clinical development and evaluation of microbiome-based medicinal products - Scientific guideline https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-development-reflection-paper-non-clinical-development-evaluation-microbiome-based-medicinal-products_en.pdf	3.2.A.2 M4
Pyrogen and Endotoxins Testing: Questions and Answers: Guidance for Industry https://www.fda.gov/media/83477/download	3.2.S.4 3.2.P.5
Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information: Guidance for Industry https://www.fda.gov/media/82945/download	3.2.S.2 3.2.P.3 3.2.A.2
Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff https://www.fda.gov/media/80481/download	3.2.R
Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry: Guidance for Industry https://www.fda.gov/media/152281/download	M1
Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products https://www.fda.gov/media/178022/download	3.2.S.2 3.2.A.2
Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA https://www.fda.gov/media/162263/download	M1
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products https://www.fda.gov/media/179858/download	3.2.R
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs https://www.fda.gov/media/162471/download	3.2.P.2 3.2.P.5
Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff https://www.fda.gov/media/119933/download	3.2.R GMP-QMS
The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls : Draft Guidance for Industry https://www.fda.gov/media/142500/download	3.2.P.2 3.2.P.5 M5
Bioavailability Studies Submitted in NDAs or INDs – General Considerations https://www.fda.gov/media/121311/download	3.2.P.2 M5
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry https://www.fda.gov/media/179545/download	3.2.P.2 3.2.R
Residual Drug in Transdermal and Related Drug Delivery Systems: Guidance for Industry https://www.fda.gov/media/79401/download	3.2.P.2 3.2.P.5
Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing: Guidance for Industry and Food and Drug Administration Staff https://www.fda.gov/media/93196/download	M1 3.2.R
Platform Technology Designation Program for Drug Development https://www.fda.gov/media/178938/download	M1
Analytical Procedures and Methods Validation for Drugs and Biologics https://www.fda.gov/media/87801/download	3.2.S.4 3.2.P.5
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry https://www.fda.gov/media/159261/download	3.2.S.3 3.2.S.4 M5
Regulatory Classification of Pharmaceutical Co-Crystals https://www.fda.gov/media/81824/download	3.2.S.1 3.2.S.3 3.2.S.4
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry: Guidance for Industry https://www.fda.gov/media/155997/download	M5
Process Validation: General Principles and Practices: Guidance for Industry https://www.fda.gov/media/71021/download	3.2.S.2 3.2.P.3 GMP-QMS
Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products https://www.fda.gov/media/183631/download	3.2.S.2 3.2.S.3 3.2.A.2
CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports https://www.fda.gov/media/79182/download	M1
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry https://www.fda.gov/media/167073/download	3.2.P.2 M5
Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for Industry https://www.fda.gov/media/114549/download	M1 3.2.P.8 GMP-QMS
PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance: Guidance for Industry https://www.fda.gov/media/71012/download	3.2.P.2 3.2.P.3 3.2.P.5
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action https://www.fda.gov/media/70867/download	3.2.P.2 3.2.P.5 M5
Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability https://www.fda.gov/media/71463/download	3.2.S.2 3.2.A.2
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs https://www.fda.gov/media/162475/download	3.2.P.2 3.2.P.5
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies: Draft Guidance for Industry https://www.fda.gov/media/189366/download	M5
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations https://www.fda.gov/media/70851/download	3.2.P.2 3.2.P.5 3.2.P.7 3.2.R
Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry https://www.fda.gov/media/95444/download	3.2.P.2 3.2.P.3 3.2.P.5
Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry https://www.fda.gov/media/141720/download	M1 3.2.S.3 3.2.P.5
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation: Guidance for Industry https://www.fda.gov/media/71141/download	M1 3.2.P.2 3.2.P.3
Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation: Guidance for Industry https://www.fda.gov/media/70857/download	3.2.P.2 3.2.P.3 3.2.P.5
Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry https://www.fda.gov/media/157812/download	3.2.S.2 3.2.P.2 3.2.P.5
Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry https://www.fda.gov/media/133676/download	3.2.R M5
Bispecific Antibody Development Programs Guidance for Industry https://www.fda.gov/media/123313/download	3.2.S.2 3.2.S.3 3.2.S.4
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry: Guidance for Industry https://www.fda.gov/media/107622/download	3.2.S.2 3.2.S.3 3.2.S.4
Quality Considerations for Topical Ophthalmic Drug Products https://www.fda.gov/media/172937/download	3.2.P.2 3.2.P.5 3.2.P.7
Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry https://www.fda.gov/media/119267/download	GMP-QMS
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry https://www.fda.gov/media/113760/download	3.2.S.2 3.2.S.4 3.2.P.3 3.2.A.2
Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry: Guidance for Industry https://www.fda.gov/media/86193/download	M1 GMP-QMS
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products https://www.fda.gov/media/170198/download	M1 3.2.S.2 3.2.P.3
Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry: Guidance for Industry https://www.fda.gov/media/84217/download	M1 3.2.S.2 3.2.S.4
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development: Draft Guidance for Industry https://www.fda.gov/media/188270/download	M5
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations https://www.fda.gov/media/132674/download	3.2.P.2 3.2.P.5
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry https://www.fda.gov/media/167043/download	3.2.P.2 3.2.P.5 M5
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products https://www.fda.gov/media/178113/download	3.2.S.2 3.2.A.2
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs https://www.fda.gov/media/162476/download	3.2.P.2 3.2.P.5
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products: Guidance for Industry and FDA Staff https://www.fda.gov/media/76403/download	3.2.R
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations https://www.fda.gov/media/70939/download	3.2.P.2 3.2.P.5
Potency Assurance for Cellular and Gene Therapy Products https://www.fda.gov/media/175132/download	3.2.S.4 3.2.P.2 3.2.P.5
Development and Submission of Near Infrared Analytical Procedures https://www.fda.gov/media/91343/download	3.2.S.4 3.2.P.3 3.2.P.5
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation https://www.fda.gov/media/70837/download	3.2.P.2 3.2.P.3 3.2.P.5
Application of Human Factors Engineering Principles for Combination Products: Questions and Answers: Guidance for Industry and FDA Staff https://www.fda.gov/media/171855/download	3.2.P.7 3.2.R
Human Gene Therapy Products Incorporating Human Genome Editing: Guidance for Industry https://www.fda.gov/media/156894/download	3.2.S.2 3.2.S.3 3.2.S.4 3.2.P.3 M5
Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications: Guidance for Industry https://www.fda.gov/media/78428/download	3.2.S.2 3.2.S.3 3.2.A.2
ICH Q3E EWG — Guideline for Extractables and Leachables https://database.ich.org/sites/default/files/ICH_Q3E_EWG_Step2_DraftGuideline_2025_0704.pdf	3.2.S.6 3.2.P.7
ICH Q5A(R2) — Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin https://database.ich.org/sites/default/files/ICH_Q5A%28R2%29_Guideline_2023_1101.pdf	3.2.S.2 3.2.A.2
ICH Q9(R1) — Quality Risk Management https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2025_0115_0.pdf	3.2.P.3 GMP-QMS
ICH Q7 — Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients https://database.ich.org/sites/default/files/Q7%20Guideline.pdf	3.2.S.2
ICH Q12 — Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf	M1 3.2.S.4 3.2.P.7
ICH Q1C — Stability Testing for New Dosage Forms https://database.ich.org/sites/default/files/Q1C%20Guideline.pdf	3.2.S.7 3.2.P.8
ICH S12 — Nonclinical Biodistribution Considerations for Gene Therapy Products https://database.ich.org/sites/default/files/ICH_S12_Step4_Guideline_2023_0314_WithCorrection_0.pdf	M4
ICH M11 EWG — Clinical electronic Structured Harmonised Protocol (CeSHarP) https://database.ich.org/sites/default/files/ICH_Step4_M11_Final_Guideline_2025_1119.pdf	M5
ICH Q2(R2) — Revision of Q2(R1) Analytical Validation https://database.ich.org/sites/default/files/ICH_Q2%28R2%29_Guideline_2023_1130_ErrorCorrection_2025.pdf	3.2.S.4 3.2.P.5
ICH Q11 — Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) https://database.ich.org/sites/default/files/Q11%20Guideline.pdf	3.2.S.2 3.2.S.3
ICH Q1D — Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products https://database.ich.org/sites/default/files/Q1D%20Guideline.pdf	3.2.S.7 3.2.P.8
ICH Q1B — Stability Testing : Photostability Testing of New Drug Substances and Products https://database.ich.org/sites/default/files/Q1B%20Guideline.pdf	3.2.S.7 3.2.P.8
ICH M13A EWG — Bioequivalence for Immediate-Release Solid Oral Dosage Forms https://database.ich.org/sites/default/files/ICH_M13A_Step4_Final_Guideline_2024_0723.pdf	3.2.P.2 M5
ICH Q1A(R2) — Stability Testing of New Drug Substances and Products https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf	3.2.S.7 3.2.P.8
ICH Q8(R2) — Pharmaceutical Development https://database.ich.org/sites/default/files/Q8%28R2%29%20Guideline.pdf	3.2.P.2 3.2.P.3
ICH M13B EWG — Bioequivalence for Immediate-Release Solid Oral Dosage Forms https://database.ich.org/sites/default/files/M13B_Draft%20Guideline_Step2_2025_0212_0.pdf	3.2.P.2 M5
ICH M7(R2) — Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk https://database.ich.org/sites/default/files/ICH_M7%28R2%29_Guideline_Step4_2023_0216_0.pdf	3.2.S.2 3.2.S.3 3.2.P.5
ICH Q14 — Analytical Procedure Development https://database.ich.org/sites/default/files/ICH_Q14_Guideline_2023_1130_ErrorCorrection_2025.pdf	3.2.S.4 3.2.P.5
ICH Q5D — Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products https://database.ich.org/sites/default/files/Q5D%20Guideline.pdf	3.2.S.2 3.2.A.2
ICH Q6B — Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products https://database.ich.org/sites/default/files/Q6B%20Guideline.pdf	3.2.S.4 3.2.P.5
ICH Q5C — Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products https://database.ich.org/sites/default/files/Q5C%20Guideline.pdf	3.2.S.7 3.2.P.8
ICH M4Q(R1) — CTD on Quality https://database.ich.org/sites/default/files/M4Q_R1_Guideline.pdf	M1 M2.3
ICH Q3C(R9) — Guideline for Residual Solvents https://database.ich.org/sites/default/files/ICH_Q3C%28R9%29_Guideline_MinorRevision_2024_2024_Approved.pdf	3.2.S.4 3.2.P.5
ICH Q3A(R2) — Impurities in New Drug Substances https://database.ich.org/sites/default/files/Q3A%28R2%29%20Guideline.pdf	3.2.S.2 3.2.S.3 3.2.S.4
ICH Q1E — Evaluation of Stability Data https://database.ich.org/sites/default/files/Q1E%20Guideline.pdf	3.2.S.7 3.2.P.8
ICH Q6A — Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances https://database.ich.org/sites/default/files/Q6A%20Guideline.pdf	3.2.S.4 3.2.P.5
ICH Q1F — Stability Data Package for Registration Applications in Climatic Zones III and IV https://database.ich.org/sites/default/files/Q1F_Stability_Guideline_WHO_2018.pdf	3.2.S.7 3.2.P.8
ICH Q13 — Continuous Manufacturing of Drug Substances and Drug Products https://database.ich.org/sites/default/files/ICH_Q13_Step4_Guideline_2022_1116.pdf	3.2.S.2 3.2.P.3
ICH Q3B(R2) — Impurities in New Drug Products https://database.ich.org/sites/default/files/Q3B%28R2%29%20Guideline.pdf	3.2.S.3 3.2.P.5
ICH Q5B — Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products https://database.ich.org/sites/default/files/Q5B%20Guideline.pdf	3.2.S.2 3.2.A.2
ICH Q3D(R2) — Guideline for Elemental Impurities https://database.ich.org/sites/default/files/Q3D-R2_Guideline_Step4_2022_0308.pdf	3.2.S.4 3.2.P.5
ICH Q1 EWG — Stability Testing of Drug Substances and Drug Products https://database.ich.org/sites/default/files/ICH_Q1EWG_Step2_Draft_Guideline_2025_0411.pdf	3.2.S.7 3.2.P.7 3.2.P.8 3.2.R
ICH Q10 — Pharmaceutical Quality System https://database.ich.org/sites/default/files/Q10%20Guideline.pdf	3.2.P.3 3.2.A.1 GMP-QMS
ICH Q5E — Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process https://database.ich.org/sites/default/files/Q5E%20Guideline.pdf	3.2.S.2 3.2.S.4 3.2.P.3
ICH M9 — Biopharmaceutics Classification System-based Biowaivers https://database.ich.org/sites/default/files/M9_Guideline_Step4_2019_1116.pdf	3.2.P.2 M5