International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use is a joint initiative involving both regulators and research-based industry focusing on the technical requirements for medical product containing new drugs.There are Six Parties from the research-based industry directly involved in the decision making process: EU, EFPIA, MHLW, JPMA, FDA and PhRMA.In November 2005, the ICH Steering Committee adopted a new codification system for ICH Guidelines. The purpose of this new codification is to ensure that the numbering/coding of ICH Guidelines is more logical, consistent and clear. With the new codification revisions to an ICH Guideline are shown as (R1, (R2), (R3) depending on the number of revisions. Annexes or Addenda to Guidelines have now been incorporated into the core Guidelines and are indicated as revisions to the core Guideline (e.g., R1).ICH Guidelines (Batch Q: Quality)StabilityQ1A (R2)Stability Testing of New Drug Substances and ProductsQ1BStability Testing: Photostability Testing of New Drug Substances and ProductsQ1CStability Testing for New Dosage FormsQ1DBracketing and Matrixing Designs for Stability Testing of New Drug Substances and ProductsQ1EEvaluation of Stability DataAnalytical ValidationQ2 (R1)Validation of Analytical Procedures: Text and MethodologyImpuritiesQ3A (R2)Impurities in New Drug SubstancesQ3B (R2)Impurities in New Drug ProductsQ3C (R4)Impurities: Guideline for Residual SolventsPharmacopeiasQ4BEvaluation and Recommendation of Pharmacopeial Texts for Use in the ICH RegionsQ4B Annex 1Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Residue on Ignition/Sulphated Ash - General ChapterQ4B Annex 2Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Test for extractable Volume of Parenteral Preparations - General ChapterQ4B Annex 3Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Test for Particulate Contamination: Sub-Visible Particles – General ChapterQ4B Annex 4AEvaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests – General ChapterQ4B Annex 4BEvaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms – General ChapterQ4B Annex 4CEvaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use – General ChapterQ4B Annex 5Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Disintegration Test – General ChapterQ4B Annex 6Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on University of Dosage Units – General ChapterQ4B Annex 7Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Dissolution Test – General ChapterQ4B Annex 8Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Sterility Chapter – General ChapterQ4B Annex 9Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Tablet Friability – General ChapterQ4B Annex 10Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions – on Polyacrylamide Gel Electrophoresis – General ChapterQuality of Biotechnological ProductsQ5A (R1)Viral Safety Evaluation of Biotechnological Products Derived from Cell Lines of Human or Animal OriginQ5BQuality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein ProductsQ5CQuality of Biotechnological Products: Stability Testing of Biotechnological/Biological ProductsQ5DDerivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological ProductsQ5EComparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing ProcessSpecificationsQ6ASpecifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (Including Decision Trees)Q6BSpecifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological ProductsGood Manufacturing PracticeQ7Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsPharmaceutical DevelopmentQ8 (R2)Pharmaceutical DevelopmentQuality Risk ManagementQ9Quality Risk ManagementPharmaceutical Quality SystemQ10Pharmaceutical Quality SystemICH Guidelines (Batch S: Safety)SafetyS1ANeed for Carcinogenicity Studies of PharmaceuticalsS1BTesting for Carcinogenicity of PharmaceuticalsS1C (R2)Dose Selection for Carcinogenicity Studies of PharmaceuticalsGenotoxicity StudiesS2 (R1)Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human UseS2AGuidance on Specific Aspects of Regulatory Genotoxicity Tests for PharmaceuticalsS2BGenotoxicity: A Standard Battery for Genotoxicity Testing of PharmaceuticalsToxicokinetics and PharmacokineticsS3ANote for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity StudiesS3BPharmacokinetics: Guidance for Repeated Dose Tissue Distribution StudiesToxicity TestingS4Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)Reproductive ToxicityS5 (R2)Detection of Toxicity to Reproduction for Medical Products & Toxicity to Male FertilityBiotechnological ProductsS6Preclinical Safety Evaluation of Biotechnology-Derived PharmaceuticalsPharmacology StudiesS7ASafety Pharmacology Studies for Human PharmaceuticalsS7BThe Non-Clinical Evaluation of Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human PharmaceuticalsImmunotoxicology StudiesS8Immunotoxicity Studies for Human PharmaceuticalsS9Nonclinical Evaluation for Anticancer PharmaceuticalsICH Guidelines (Batch M: Multidisciplinary)M2 ICSR (R2)Electronic Transmission of Individual Case Safety Reports Message Specification (ICH ICSR DTD Version 2.1) companion document to E2B (R3)M3 (R1)Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for PharmaceuticalsM3 (R2)Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for PharmaceuticalsM4 (R3)Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use – Including the Annex; The Granularity DocumentM4Q (R1)The Common Technical Document for the Registration of Pharmaceuticals for Human Use: QualityM4S (R2)The Common Technical Document for the Registration of Pharmaceuticals for Human Use: SafetyM4E (R1)The Common Technical Document for the Registration of Pharmaceuticals for Human Use: EfficacyM5Data Elements and Standards for Drug DictionariesICH Guidelines (Batch E: Efficacy)EfficacyE1The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening ConditionsE2AClinical Safety Data Management: Definitions and Standards for Expedited ReportingE2B (R3)Second Revision of the Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety ReportsTo read together with M2 ICSR (R2) Message Specification (ICH ICSR DTD Version 2.1 February 2001)E2C (R1)Clinical Safety Data Management: Periodic Safety Update Reports for Marketed DrugsE2DPost-Approval Safety Data Management: Definitions and Standards for Expedited ReportingE2E
