Adoption Date | Document title | ICH Guidelines Topic Code |
August 2023 | THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL SAFETY FOR DRUGS INTENDED FOR LONG-TERM TREATMENT OF NON-LIFE-THREATENING CONDITIONS | E1 |
September 2015 | CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING | E2A |
September 2015 | PERIODIC BENEFIT-RISK EVALUATION REPORT (PBRER) | E2C(R2) |
September 2015 | POST-APPROVAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING | E2D |
September 2015 | PHARMACOVIGILANCE PLANNING | E2E |
July 2015 | STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS | E3 |
August 2023 | DOSE-RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION | E4 |
August 2023 | ETHNIC FACTORS IN THE ACCEPTABILITY OF FOREIGN CLINICAL DATA | E5(R1) |
August 2023 | STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS | E7 |
August 2023 | GENERAL CONSIDERATIONS FOR CLINICAL STUDIES | E8(R1) |
August 2023 | STATISTICAL PRINCIPLES FOR CLINICAL TRIALS | E9 |
August 2023 | ADDENDUM ON ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS TO THE GUIDELINE ON STATISTICAL PRINCIPLES FOR CLINICAL TRIALS | E9(R1) |
August 2023 | CHOICE OF CONTROL GROUP AND RELATED ISSUES IN CLINICAL TRIALS | E10 |
August 2023 | GENERAL PRINCIPLES FOR PLANNING AND DESIGN OF MULTI-REGIONAL CLINICAL TRIALS | E17 |
August 2023 | A SELECTIVE APPROACH TO SAFETY DATA COLLECTION IN SPECIFIC LATE-STAGE PRE-APPROVAL OR POST-APPROVAL CLINICAL TRIALS | E19 |
September 2011 | VALIDATION OF ANALYTICAL PROCEDURES | Q2(R2) |
September 2011 | IMPURITIES IN NEW DRUG SUBSTANCES | Q3A(R2) |
September 2011 | IMPURITIES IN NEW DRUG PRODUCTS | Q3B(R2) |
September 2011 | IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS | Q3C(R9) |
September 2011 | GUIDELINE FOR ELEMENTAL IMPURITIES | Q3D(R2) |
September 2011 | QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF R-DNA DERIVED PROTEIN PRODUCTS | Q5B |
February 2011 | QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS | Q5C |
September 2011 | DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS | Q5D |
August 2017 | COMPARABILITY OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS | Q5E |
September 2011 | SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAL SUBSTANCES | Q6A |
September 2011 | SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS | Q6B |
July 2011 | GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS | Q7 |
July 2011 | PHARMACEUTICAL DEVELOPMENT | Q8(R2) |
July 2011 | QUALITY RISK MANAGEMENT | Q9(R1) |
July 2011 | PHARMACEUTICAL QUALITY SYSTEM | Q10 |
July 2011 | DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES) | Q11 |
November 2023 | CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS | Q13 |
January 2024 | GUIDELINE ON NEED FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS | S1A |
January 2024 | TESTING FOR CARCINOGENICITY OF PHARMACEUTICALS | S1B(R1) |
January 2024 | DOSE SELECTION FOR CARCINOGENICITY STUDIES OF PHARMACEUTICALS | S1C(R2) |
January 2024 | GUIDANCE ON GENOTOXICITY TESTING AND DATA INTERPRETATION FOR PHARMACEUTICALS INTENDED FOR HUMAN USE | S2(R1) |
January 2024 | NOTE FOR GUIDANCE ON TOXICOKINETICS: THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES | S3A |
January 2024 | GUIDANCE FOR REPEATED DOSE TISSUE DISTRIBUTION STUDIES | S3B |
January 2024 | DURATION OF CHRONIC TOXICITY TESTING IN ANIMALS (RODENT AND NON RODENT TOXICITY TESTING). | S4 |
January 2024 | DETECTION OF REPRODUCTIVE AND DEVELOPMENTAL TOXICITY FOR HUMAN PHARMACEUTICALS | S5(R3) |
March 2021 | PRECLINICAL SAFETY EVALUATION OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS | S6(R1) |
March 2021 | SAFETY PHARMACOLOGY STUDIES FOR HUMAN PHARMACEUTICALS | S7A |
March 2021 | THE NON-CLINICAL EVALUATION OF THE POTENTIAL FOR DELAYED VENTRICULAR REPOLARIZATION (QT INTERVAL PROLONGATION) BY HUMAN PHARMACEUTICALS | S7B |
January 2024 | IMMUNOTOXICITY STUDIES FOR HUMAN PHARMACEUTICALS | S8 |
March 2021 | NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS | S9 |
January 2024 | NONCLINICAL SAFETY TESTING IN SUPPORT OF DEVELOPMENT OF PAEDIATRIC MEDICINES | S11 |
January 2024 | NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS | S12 |
March 2021 | GUIDANCE ON NONCLINICAL SAFETY STUDIES FOR THE CONDUCT OF HUMAN CLINICAL TRIALS AND MARKETING AUTHORIZATION FOR PHARMACEUTICALS | M3(R2) |
September 2011 | ORGANISATION INCLUDING THE GRANULARITY DOCUMENT THAT PROVIDES GUIDANCE ON DOCUMENT LOCATION AND PAGINATIONS | M4(R4) |
September 2011 | CTD on Efficacy | M4E(R2) |
September 2011 | CTD on Safety | M4S(R2) |
September 2011 | CTD on Quality | M4Q(R1) |
April 2026 | ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK | M7(R2) |
| September 2015 | https://ich.org/page/electronic-standards-estri | E2B (R3) |
| September 2015 | ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs): Questions and Answers | E2B(R3) Q&As |
| September 2015 | Post-approval safety data: definitions and standards for management and reporting of individual case safety report | E2D(R1) |
| October 2025 | Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin | Q5A (R2) |
| March 2026 | General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise RealWorld Data for Safety Assessment of Medicines | M14 |
| March 2021 | Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals | S9 Q&As |
| July 2024 | Photosafety Evaluation of Pharmaceuticals | S10 |
| July 2011 | Implementation | Q8/Q9/Q10 Q&As (R5) |
| July 2011 | Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients | Q7 Q&As |
| September 2011 | Tablet Friability General Chapter | Q4B Annex 9(R1) |
| September 2011 | Sterility Test General Chapter | Q4B Annex 8(R1) |
| September 2011 | Dissolution Test General Chapter | Q4B Annex 7(R2) |
| September 2011 | Uniformity of Dosage Units General Chapter | Q4B Annex 6 |
| September 2011 | Disintegration Test General Chapter | Q4B Annex 5(R1) |
| September 2011 | Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter | Q4B Annex 4C(R1) |
| September 2011 | Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter | Q4B Annex 4B(R1) |
| September 2011 | Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter | Q4B Annex 4A(R1) |
| September 2011 | Test for Particulate Contamination: Sub-Visible Particles General Chapter | Q4B Annex 3(R1) |
| September 2011 | Test for Extractable Volume of Parenteral Preparations General Chapter | Q4B Annex 2(R1) |
| September 2011 | Bacterial Endotoxins Test General Chapter | Q4B Annex 14 |
| September 2011 | Bulk Density and Tapped Density of Powders General Chapter | Q4B Annex 13 |
| September 2011 | Analytical Sieving General Chapter | Q4B Annex 12 |
| September 2011 | Capillary Electrophoresis General Chapter | Q4B Annex 11 |
| September 2011 | Polyacrylamide Gel Electrophoresis General Chapter | Q4B Annex 10(R1) |
| September 2011 | Residue on Ignition/Sulphated Ash General Chapter | Q4B Annex 1(R1) |
| September 2011 | Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions | Q4B |
| September 2011 | Evaluation of Stability Data | Q1E |
| May 2011 | Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products | Q1D |
| May 2011 | Stability Testing for New Dosage Forms | Q1C |
| May 2011 | Stability Testing : Photostability Testing of New Drug Substances and Products | Q1B |
| May 2011 | Stability Testing of New Drug Substances and Products | Q1A(R2) |
| July 2011 | Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances | Q11 Q&As |
| September 2011 | Electronic Common Technical Document (eCTD) v3.2.2 | M8 eCTD v3.2.2 |
| September 2011 | Questions & Answers: CTD on Quality | M4Q Q&As (R1) |
| September 2011 | Questions & Answers: Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use | M4 Q&As (R3) |
| March 2021 | Questions & Answers: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals | M3(R2) Q&As (R2) |
| September 2015 | MedDRA – Medical Dictionary for Regulatory Activities | M1 |
| April 2026 | Good Clinical Practice (GCP) | E6 (R3) |
| August 2023 | Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data | E5 Q&As (R1) |
| September 2015 | Questions & Answers: Periodic Benefit-Risk Evaluation Report | E2C(R2) Q&As |
| March 2021 | Clinical Investigation of Medicinal Products in the Pediatric Population: Guideline and Addendum | E11(R1) |
| November 2020 | DEVELOPMENT SAFETY UPDATE REPORT | E2F |
| July 2015 | Questions & Answers (R1): Structure and Content of Clinical Study Reports | E3 Q&As (R1) |
| August 2023 | Questions & Answers: Studies in Support of Special Populations: Geriatrics | E7 Q&As |
| April 2026 | BIOANALYTICAL METHOD VALIDATION AND STUDY SAMPLE ANALYSIS | M10 |
| April 2026 | CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL (CESHARP) | M11 |
| April 2026 | DRUG INTERACTION STUDIES | M12 |
| April 2026 | IOEQUIVALENCE FOR IMMEDIATERELEASE SOLID ORAL DOSAGE FORMS | M13A |
| April 2026 | GENERAL PRINCIPLES FOR MODEL-INFORMED DRUG DEVELOPMENT | M15 |
| September 2011 | Questions & Answers(R4): CTD on Efficacy | M4E Q&As (R4) |
| September 2011 | Questions & Answers(R4): CTD on Safety | M4S Q&As (R2) |
| April 2026 | BIOPHARMACEUTICS CLASSIFICATION SYSTEM-BASED BIOWAIVERS | M9 |
| April 2026 | Questions and Answers(M9):BIOPHARMACEUTICS CLASSIFICATION SYSTEM-BASED BIOWAIVERS | M9 Q&As |
| January 2024 | QUESTIONS AND ANSWERS TO ICH S3A: NOTE FOR GUIDANCE ONTOXICOKINETICS: THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES FOCUS ON MICROSAMPLIN | S3A Q&As |
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