ICH Guidelines are the Heart and Soul of the Pharmaceutical Industry. ICH is an organization that provides Guidance for the Pharma sector to meet regulatory requirements.
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Complete list of ICH Guidelines 2024
Background of ICH Guidelines
ICH was established in 1990. The International Council is a bridge between regulatory authorities and the pharmaceutical industry. Because it helps to discuss the scientific and technical requirements of pharmaceuticals and develop guidelines accordingly. The organization gradually evolved and the ICH guidelines are applied by regulatory authorities.
The ICH mission is to achieve Harmonisation to ensure safe, effective, and high-quality medicines are developed, registered and maintained efficiently to meet the standards. ICH includes 17 Members and 32 Observers after the announcement of organizational changes in October 2015.
What is the full form of ICH Guidelines?
The full form of ICH is “The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use”. In the early days, ICH was called as “International Conference on Harmonisation”.
Implementation Status
The Harmonized ICH Guidelines are implemented within the respective country or region. The Regulatory Members should implement all Guidelines in line with the respective laws and or rules.
The The International Council for Harmonisation will monitor the progress of international Harmonisation and the level of implementation and adherence to ICH Guidelines within Regulatory Member and Observer countries/regions.
ICH Guidelines List
There are four types available for reference and implementation.
- ICH Quality Guidelines
- ICH Safety Guidelines
- ICH Efficacy Guidelines
- ICH Multidisciplinary Guidelines
An index and complete list are illustrated below for easy understanding.
Latest ICH Quality Guidelines 2024
The ICH Quality Guidelines are the Holy Guidance to the Pharmaceutical Industry to meet the regulatory and cGMP requirements.
The Harmonization goals in the Quality include notable milestones including performing Stability studies, defining thresholds for impurities testing, and a more flexible approach to pharmaceutical quality based on Current Good Manufacturing Practice (cGMP) risk management.
The Quality guidelines are divided into sections, namely from “Q1 to Q14”. A complete list of ICH Quality Guidelines is illustrated below for easy reference.
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ICH Stability Guidelines (Q1A – Q1F)
Stability Studies are the most important subject in the Pharmaceutical world, where ICH Stability guidelines provides the best in class guidance. The details are as follows.
Q1A (R2) – Stability Testing of New Drug Substances and Products
Q1B – Stability Testing – Photostability Testing of New Drug Substances and Products
Q1C – Stability Testing for New Dosage Forms
Q1D – Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Q1E – Evaluation of Stability Data
Q1F – Stability Data Package for Registration Applications in Climatic Zones III and IV
Analytical Validation Guidelines (Q2)
Analytical Method Validation is one of the most important subject. The details are follows.
Q2 (R1) – Validation of Analytical Procedures: Text and Methodology
Q2 (R2)/ Q14 – Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation
Impurities Guidelines (Q3A – Q3E)
Impurity Studies are the key aspect of Pharmaceutical industry. The list of details are as follows.
Q3A (R2) – Impurities in New Drug Substances
Q3B (R2) – Impurities in New Drug Products
Q3C (R6) – Maintenance of the Guideline for Residual Solvents
Q3C (R8) – Maintenance of the Guideline for Residual Solvents
Q3D(R1) – Guideline for Elemental Impurities
Q3D(R2) – Maintenance of Q3D(R1) for cutaneous and transdermal products
Q3D training – Implementation of Guideline for Elemental Impurities
Q3E- Impurity Assessment and Control of Extractables and Leachable for Pharmaceuticals and Biologics
Pharmacopoeias Guidelines (Q4A – Q4B)
Q4A – Pharmacopoeial Harmonisation
Q4B – Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Annexures to ICH Q4 (Annex 1 – 7)
Annex1 (R1) – Residue on Ignition/Sulphated Ash General Chapter
Annex2 (R1) – Test for Extractable Volume of Parenteral Preparations General Chapter
Annex3 (R1) – Test for Particulate Contamination: Sub-Visible Particles General Chapter
Annex4A (R1) – Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
Annex4B (R1) – Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter
Annex4C (R1) – Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
Annex5 (R1) – Disintegration Test General Chapter
Annex6 – Uniformity of Dosage Units General Chapter
Annex7 (R2) – Dissolution Test General Chapter
Annexures to ICH Q4 (Annex 8 – 14)
Annex8 (R1) – Sterility Test General Chapter
Annex9 (R1) – Tablet Friability General Chapter
Annex10 (R1) – Polyacrylamide Gel Electrophoresis General Chapter
Annex11 – Capillary Electrophoresis General Chapter
Annex12 – Analytical Sieving General Chapter
Annex13 – Bulk Density and Tapped Density of Powders General Chapter
Annex14 – Bacterial Endotoxins Test General Chapter
Quality of Biotechnological Products (Q5A – Q5E)
Q5A (R1) – Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Q5A (R2) – Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Q5B – Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Q5C – Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
Q5D – Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
Q5E – Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
ICH Quality Guidelines – Specifications (ICH Q6A – Q6B)
Q6A Specifications – Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Q6B Specifications – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Good Manufacturing Practice Guidelines (ICH Q7) (GMP / cGMP)
Current Good Manufacturing Practice Guidelines (ICH Q7) (GMP / cGMP) are the most important subject in ICH Quality Guidelines. This ICH Q7 is a Key aspect of the Pharmaceutical industry. The list is as follows.
Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Q7 Q&A – Questions and Answers – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
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Pharmaceutical Development Guidelines (Q8)
Q8 (R2) – Pharmaceutical Development
Quality Risk Management Guidelines (ICH Q9)
Q9 (R1) – Quality Risk Management
Pharmaceutical Quality System (Q10)
Q10 – Pharmaceutical Quality System
Development and Manufacture of Drug Substances (Q11)
Q11 – Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
Q11 Q&A – (Q11 Questions & Answers) – Selection and Justification of Starting Materials for the Manufacture of Drug Substances
Lifecycle Management Guidelines (Q12)
Q12 – Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
Q12 Training – on Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management
Continuous Manufacturing of Drug Substances and Drug Products (Q13)
Q13 – Continuous Manufacturing of Drug Substances and Drug Products
Analytical Procedure Development Guidelines (Q14)
Q14/Q2 (R2) – Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation
ICH Quality Guidelines Index
The above ICH Quality Guidelines list is detailed/elaborated. Hence, the simple Index is illustrated below for easy understanding.
Q1A – Q1F – Stability
Q2 – Analytical Validation
Q3A – Q3E – Impurities
Q4A – Q4B – Pharmacopoeias
Q5A – Q5E – Quality of Biotechnological Products
Q6A – Q6B – Specifications
Q7 – Good Manufacturing Practice (GMP)
Q8 – Pharmaceutical Development
Q9 – Quality Risk Management
Q10 – Pharmaceutical Quality System
Q11 – Development and Manufacture of Drug Substances
Q12 – Lifecycle Management
Q13 – Continuous Manufacturing of Drug Substances and Drug Products
Q14 – Analytical Procedure Development
ICH Safety Guidelines
ICH Safety Guidelines are one of the key guidelines for the Pharma Industry. The Organization prepared safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity, and nephrotoxicity. ICH has introduced to eliminate potential risks like carcinogenicity, genotoxicity, and nephrotoxicity.
A complete list of guidance are illustrated below for easy reference.
ICH Guidelines pdf / Guidelines ppt, refer here at Latest ICH Safety Guidelines 2023
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ICH Safety Guidelines (S1 – S6)
A list of ICH Safety guidelines from S1 to S6 is provided below.
S1A – S1C: Carcinogenicity Studies. -> S1A Need for Carcinogenicity Studies of Pharmaceuticals.
S1B: Testing for Carcinogenicity of Pharmaceuticals.
S1C (R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals.
S1 (R1): EWG Rodent Carcinogenicity Studies for Human Pharmaceuticals.
S2: Genotoxicity Studies.
S2 (R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use.
S3A – S3B: Toxicokinetics and Pharmacokinetics. -> Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies.
(S3A Q&A) : Questions and Answers – Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure – Focus on Microsampling.
S3B : Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies.
S4: Toxicity Testing.
S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing).
S5: Reproductive Toxicology.
(R3) Revision of S5: Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals.
S5 (R4): Maintenance EWG Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals.
S6: Biotechnological Products.
S6 (R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.
ICH Safety Guidelines (S7 – S12)
S7A – S7B: Pharmacology Studies -> S7A: Safety Pharmacology Studies for Human Pharmaceuticals
S7B: The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals.
E14/S7B: IWG Questions & Answers – Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential.
S8: Immunotoxicology Studies. -> Immunotoxicity Studies for Human Pharmaceuticals.
S9: Nonclinical Evaluation for Anticancer Pharmaceuticals. -> Nonclinical Evaluation for Anticancer Pharmaceuticals.
S9 Q&A: Questions and Answers – Nonclinical Evaluation for Anticancer Pharmaceuticals.
S10: Photosafety Evaluation. -> Photosafety Evaluation of Pharmaceuticals.
S11: Nonclinical Paediatric Safety. -> Nonclinical Safety Testing in Support of Development of Paediatric Medicines.
S12: Non-clinical Biodistribution Studies for Gene Therapy Products. -> EWG Non-clinical Biodistribution Studies for Gene Therapy Products.
Safety Index
A list of snippets is provided below.
S1A – S1C – Carcinogenicity Studies
S2 – Genotoxicity Studies
S3A – S3B – Toxicokinetics and Pharmacokinetics
S4 – Toxicity Testing
S5 – Reproductive Toxicology
S6 – Biotechnological Products
S7A – S7B – Pharmacology Studies
S8 – Immunotoxicology Studies
S9 – Nonclinical Evaluation for Anticancer Pharmaceuticals
S10 – Photosafety Evaluation
S11 – Nonclinical Paediatric Safety
S12 – Non-clinical Biodistribution Studies for Gene Therapy Products
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ICH Efficacy Guidelines
The ICH Efficacy Guidelines consist of the drug design, conduct, safety, and reporting of clinical trials. It also discusses the biotechnological processes, Pharmacogenetics techniques, and Pharmacogenomics. These are one of the key guidelines and introduced as guidance to the Pharma Industry to meet the requirements.
ICH Guidelines ppt, refer here Latest ICH Efficacy Guidelines 2023
A list of complete are illustrated below for easy reference.
ICH Efficacy Guidelines List (E1 – E5)
A list of ICH Efficacy Guidelines from E1 to E5 is provided below.
E1: Clinical Safety for Drugs Used in Long-Term Treatment.
The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions.
E2A – E2F : Pharmacovigilance.
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
E2B(R3): Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs).
E2B Q&A: Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports.
E2B(R3) EWG/IWG: Electronic Transmission of Individual Case Safety Reports (ICSRs).
E2C(R2): Periodic Benefit-Risk Evaluation Report.
E2C(R2) Q&A: Questions & Answers: Periodic Benefit-Risk Evaluation Report.
E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting.
E2D(R1): EWGPost Approval Safety Data Management: Definition and Standards for Expedited Reporting.
E2E: Pharmacovigilance Planning.
E2F: Development Safety Update Report.
E3: Clinical Study Reports.
E3: Structure and Content of Clinical Study Reports.
E3 Q&As (R1): Questions & Answers: Structure and Content of Clinical Study Reports.
E4: Dose-Response Studies.
Dose-Response Information to Support Drug Registration.
E5: Ethnic Factors.
E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data.
E5 Q&A (R1): Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data.
ICH Efficacy Guidelines List (E6 – E10)
A list of ICH Efficacy Guidelines from E6 to E10 is provided below.
E6: Good Clinical Practice.
E6(R2): Good Clinical Practice (GCP).
E6(R3): EWG Good Clinical Practice (GCP).
E7: Clinical Trials in Geriatric Population.
Studies in Support of Special Populations: Geriatrics.
E7 Q&A: Questions & Answers – Studies in Support of Special Populations: Geriatrics.
E8: General Considerations for Clinical Trials.
General Considerations for Clinical Trials.
E8(R1): EWG Revision on General Considerations for Clinical Studies.
E9: Statistical Principles for Clinical Trials.
Statistical Principles for Clinical Trials.
E9(R1): EWG Addendum – Statistical Principles for Clinical Trials
E10: Choice of Control Group in Clinical Trials and Choice of Control Group and Related Issues in Clinical Trials
ICH Efficacy Guidelines List (E11 – E15)
A list of ICH Efficacy Guidelines from E11 to E15 is provided below.
E11: E11A Clinical Trials in Pediatric Population
E11(R1)Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population
E11A: EWG Paediatric Extrapolation
E12: Clinical Evaluation by Therapeutic Category
E12: Principles for Clinical Evaluation of New Antihypertensive Drugs
E14: Clinical Evaluation of QT
The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
E14 Q&As (R3)Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
E14/S7B: IWGQuestions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential
E15: Definitions in Pharmacogenetics / Pharmacogenomics
Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data, and Sample Coding Categories.
ICH Efficacy Guidelines List (E16 – E20)
A list of ICH Efficacy Guidelines from E16 to E20 is provided below.
E16: Qualification of Genomic Biomarkers
Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions
E17: Multi-Regional Clinical Trials
General principles for planning and design of Multi-Regional Clinical Trials
E18: Genomic Sampling
Genomic Sampling and Management of Genomic Data
E19: Safety Data Collection
E19: EWG Optimization of Safety Data Collection
E20: Adaptive Clinical Trials
EWG Adaptive Clinical Trials
ICH Efficacy Guidelines Index
To simplify the above complete details, snippets are given below.
E1 Clinical Safety for Drugs Used in Long-Term Treatment
E2A – E2F Pharmacovigilance
E3 Clinical Study Reports
E4 Dose-Response Studies
E5 Ethnic Factors
E6 Good Clinical Practice
E7 Clinical Trials in Geriatric Population
E8 General Considerations for Clinical Trials
E9 Statistical Principles for Clinical Trials
E10 Choice of Control Group in Clinical Trials
E11 – E11A Clinical Trials in Pediatric Population
E12 Clinical Evaluation by Therapeutic Category
E14 Clinical Evaluation of QT
E15 Definitions in Pharmacogenetics / Pharmacogenomics
E16 Qualification of Genomic Biomarkers
E17 Multi-Regional Clinical Trials
E18 Genomic Sampling
E19 Safety Data Collection
E20 Adaptive Clinical Trials
Read other articles – 13 Latest ICH Multidisciplinary Guidelines
13 Latest ICH Multidisciplinary Guidelines
ICH Multidisciplinary Guidelines are one of the Key Guidelines out of four which are guiding principles for the Pharma Industry to meet regulatory requirements.
These are unique and include Medical terminology (MedDRA), the Common Technical Document (CTD), and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
A complete list is illustrated below for easy reference.
First 7 ICH Multidisciplinary Guidelines (M1 – M7)
A list of ICH Multidisciplinary Guidelines is provided below from M1 to M7 with Title.
M1: MedDRA Terminology.
M1MedDRA – Medical Dictionary for Regulatory Activities.
M1 PtC WGMedDRA Points to Consider.
M2: Electronic Standards.
M2 EWGElectronic Standards for the Transfer of Regulatory Information.
M3: Nonclinical Safety Studies.
M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.
M3(R2) Q&As (R2): Questions & Answers: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.
M4: Common Technical Document.
CTD: The Common Technical Document.
M5: Data Elements and Standards for Drug Dictionaries.
Data Elements and Standards for Drug Dictionaries.
M6: Gene Therapy.
Virus and Gene Therapy Vector Shedding and Transmission.
M7: Mutagenic impurities.
M7(R1): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.
M7(R2): Maintenance EWG/assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.
ICH Multidisciplinary Guidelines (M8 – M13)
A list from M8 to M13 with titles is given below.
M8: Electronic Common Technical Document (eCTD)
eCTD v3.2.2: Electronic Common Technical Document (eCTD) v3.2.2
M8 eCTD v4.0: Electronic Common Technical Document (eCTD) v4.0
EWG/IWG: Electronic Common Technical Document (eCTD)
M9: Biopharmaceutics Classification System-based Biowaivers
Biopharmaceutics Classification System-based Biowaivers
M9 Q&A: Q&As on Biopharmaceutics Classification System-based Biowaivers
M10: Bioanalytical Method Validation
M10 EWG: Bioanalytical Method Validation
M11: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
M11 EWG: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
M12: Drug Interaction Studies
M12 EWG: Drug Interaction Studies
M13: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
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ICH Multidisciplinary Guidelines Index
A simple list is illustrated below for easy reference.
M1 – MedDRA Terminology
M2 – Electronic Standards
M3 – Nonclinical Safety Studies
M4 – Common Technical Document
M5 – Data Elements and Standards for Drug Dictionaries
M6 – Gene Therapy
M7 – Mutagenic impurities
M8 – Electronic Common Technical Document (eCTD)
M9 – Biopharmaceutics Classification System-based Biowaivers
M10 – Bioanalytical Method Validation
M11 – Clinical Electronic Structured Harmonised Protocol (CeSHarP)
M12 – Drug Interaction Studies
M13 – Bioequivalence for Immediate-Release Solid Oral Dosage Forms
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