ICH guidelines

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Every ICH guideline record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

1. e1The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for…
2. e10Choice of Control Group and Related Issues in Clinical Trials
3. e11a-ewgPaediatric Extrapolation
4. e11-r1Clinical Investigation of Medicinal Products in the Pediatric Population: Guideline and…
5. e11-r1-ewg-listAddendum: Clinical Investigation of Medicinal Products in the Pediatric Population
6. e12Principles for Clinical Evaluation of New Antihypertensive Drugs
7. e14The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for…
8. e14-q-as-r3Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and…
9. e14-s7b-q-a-r1Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation…
10. e15Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and…
11. e16Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and…
12. e17General principles for planning and design of Multi-Regional Clinical Trials
13. e17-iwg-listGeneral principles for planning and design of Multi-Regional Clinical Trials
14. e18Genomic Sampling and Management of Genomic Data
15. e18-ewg-listGenomic Sampling and Management of Genomic Data
16. e19A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or…
17. e20-ewgAdaptive Designs for Clinical Trials
18. e21-ewgInclusion of Pregnant and Breastfeeding Individuals in Clinical Trials
19. e22-ewgGeneral Considerations for Patient Preference Studies
20. e23-ewgConsiderations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision…
21. e2aClinical Safety Data Management: Definitions and Standards for Expedited Reporting
22. e2b-r3Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety…
23. e2b-r3-ewg-iwgElectronic Transmission of Individual Case Safety Reports (ICSRs)
24. e2b-r3-q-asClinical Safety Data Management: Data Elements for Transmission of Individual Case Safety…
25. e2c-r2Periodic Benefit-Risk Evaluation Report
26. e2c-r2-q-asQuestions & Answers: Periodic Benefit-Risk Evaluation Report
27. e2dPost-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
28. e2d-r1Post-Approval Safety Data: Definitions and Standards for Management and Reporting of…
29. e2ePharmacovigilance Planning
30. e2fDevelopment Safety Update Report
31. e3Structure and Content of Clinical Study Reports
32. e3-q-as-r1Questions & Answers: Structure and Content of Clinical Study Reports
33. e4Dose-Response Information to Support Drug Registration
34. e5-q-as-r1Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data
35. e5-r1Ethnic Factors in the Acceptability of Foreign Clinical Data
36. e6-r3Good Clinical Practice (GCP)
37. e6-r3-good-clinical-practice-gcp-annex-2
38. e7Studies in Support of Special Populations: Geriatrics
39. e7-q-asQuestions & Answers: Studies in Support of Special Populations : Geriatrics
40. e8-r1General Considerations for Clinical Studies
41. e9Statistical Principles for Clinical Trials
42. e9-r1Addendum: Statistical Principles for Clinical Trials
43. m1MedDRA - Medical Dictionary for Regulatory Activities
44. m10Bioanalytical Method Validation and Study Sample Analysis
45. m10-q-asQuestions and Answers: Bioanalytical Method Validation and Study Sample Analysis
46. m11-ewgClinical electronic Structured Harmonised Protocol (CeSHarP)
47. m12Drug Interaction Studies
48. m12-q-asQuestion and Answers: Drug Interactions Studies
49. m13a-ewgBioequivalence for Immediate-Release Solid Oral Dosage Forms
50. m13a-q-asQuestion and Answers: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
51. m13b-ewgBioequivalence for Immediate-Release Solid Oral Dosage Forms
52. m13c-ewgBioequivalence for Immediate-Release Solid Oral Dosage Forms
53. m14General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies…
54. m15-ewgGeneral Principles for Model-Informed Drug Development
55. m16-ewgStructured Product Quality Submissions
56. m18-ewgFramework for Determining the Utility of Comparative Efficacy Studies in Biosimilar…
57. m1-ptc-wgMedDRA Points to Consider
58. m2-ewgElectronic Standards for the Transfer of Regulatory Information
59. m3-r2Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and…
60. m3-r2-q-as-r2Questions & Answers: Guidance on Nonclinical Safety Studies for the Conduct of Human…
61. m5Data Elements and Standards for Drug Dictionaries
62. m6Virus and Gene Therapy Vector Shedding and Transmission
63. m7-r2Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit…
64. m7-r2-q-asAssessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit…
65. m7-r3-maintenance-ewg-iwgAssessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit…
66. m7-sub-groupRisk Assessment and Control of Nitrosamine Impurities
67. m8-ectd-v3-2-2Electronic Common Technical Document (eCTD) v3.2.2
68. m8-ectd-v4-0Electronic Common Technical Document (eCTD) v4.0
69. m8-ewg-iwgElectronic Common Technical Document (eCTD)
70. m9Biopharmaceutics Classification System-based Biowaivers
71. m9-q-asQ&As on Biopharmaceutics Classification System-based Biowaivers
72. q10Pharmaceutical Quality System
73. q11Development and Manufacture of Drug Substances (Chemical Entities and…
74. q11-q-asQuestions & Answers: Selection and Justification of Starting Materials for the Manufacture…
75. q12Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
76. q13Continuous Manufacturing of Drug Substances and Drug Products
77. q14Analytical Procedure Development
78. q1a-r2Stability Testing of New Drug Substances and Products
79. q1bStability Testing : Photostability Testing of New Drug Substances and Products
80. q1cStability Testing for New Dosage Forms
81. q1dBracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
82. q1eEvaluation of Stability Data
83. q1-ewgStability Testing of Drug Substances and Drug Products
84. q1fStability Data Package for Registration Applications in Climatic Zones III and IV
85. q2-r2Validation of Analytical Procedures
86. q2-r2-q14Training on Validation of Analytical Procedures and Q14: Analytical Procedure Development
87. q3a-r2Impurities in New Drug Substances
88. q3b-r2Impurities in New Drug Products
89. q3c-r10-maintenance-ewgMaintenance of the Guideline for Residual Solvents
90. q3c-r9Guideline for Residual Solvents
91. q3d-r2Guideline for Elemental Impurities
92. q3d-r3-maintenanceMaintenance of the Guideline for Elemental Impurities
93. q3e-ewgGuideline for Extractables and Leachables
94. q4aPharmacopoeial Harmonisation
95. q4b-annex-10-r1Polyacrylamide Gel Electrophoresis General Chapter
96. q4b-annex-11Capillary Electrophoresis General Chapter
97. q4b-annex-12Analytical Sieving General Chapter
98. q4b-annex-13Bulk Density and Tapped Density of Powders General Chapter
99. q4b-annex-14Bacterial Endotoxins Test General Chapter
100. q4b-annex-1-r1Residue on Ignition/Sulphated Ash General Chapter
101. q4b-annex-2-r1Test for Extractable Volume of Parenteral Preparations General Chapter
102. q4b-annex-3-r1Test for Particulate Contamination: Sub-Visible Particles General Chapter
103. q4b-annex-4a-r1Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General…
104. q4b-annex-4b-r1Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms…
105. q4b-annex-4c-r1Microbiological Examination of Non-Sterile Products: Acceptance Criteria for…
106. q4b-annex-5-r1Disintegration Test General Chapter
107. q4b-annex-6Uniformity of Dosage Units General Chapter
108. q4b-annex-7-r2Dissolution Test General Chapter
109. q4b-annex-8-r1Sterility Test General Chapter
110. q4b-annex-9-r1Tablet Friability General Chapter
111. q4b-faqsFrequently Asked Question
112. q4b-r1Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
113. q5a-r2Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or…
114. q5bAnalysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein…
115. q5cQuality of Biotechnological Products: Stability Testing of Biotechnological/Biological…
116. q5dDerivation and Characterisation of Cell Substrates Used for Production of…
117. q5eComparability of Biotechnological/Biological Products Subject to Changes in their…
118. q5e-annex-ewgComparability of Advanced Therapy Medicinal Products (ATMPs) Subject to Changes in Their…
119. q6aSpecifications : Test Procedures and Acceptance Criteria for New Drug Substances and New…
120. q6bSpecifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological…
121. q6-r1-ewgRevision of the Specifications Guidelines
122. q7Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
123. q7-q-asQuestions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical…
124. q8-q9-q10Implementation
125. q8-r2Pharmaceutical Development
126. q9-r1Quality Risk Management
127. q9-r1-iwg2023-2024 Training on Quality Risk Management
128. q9-r1-training-group-2024-2025-quality-risk-management
129. s10Photosafety Evaluation of Pharmaceuticals
130. s11Nonclinical Safety Testing in Support of Development of Paediatric Medicines
131. s12Nonclinical Biodistribution Considerations for Gene Therapy Products
132. s13-ewgNonclinical Safety Studies for Oligonucleotide-based Therapeutics
133. s1aNeed for Carcinogenicity Studies of Pharmaceuticals
134. s1b-r1Testing for Carcinogenicity of Pharmaceuticals
135. s1b-r1-iwgTraining on Testing for Carcinogenicity of Pharmaceuticals
136. s1c-r2Dose Selection for Carcinogenicity Studies of Pharmaceuticals
137. s2-r1Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for…
138. s3aNote for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity…
139. s3a-q-asQuestions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic…
140. s3bPharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
141. s4Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)
142. s5-r3Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human…
143. s5-r4Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human…
144. s6-r1Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
145. s7aSafety Pharmacology Studies for Human Pharmaceuticals
146. s7bThe Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT…
147. s8Immunotoxicity Studies for Human Pharmaceuticals
148. s9Nonclinical Evaluation for Anticancer Pharmaceuticals
149. s9-q-asQuestions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals