JUST FOR AT A GLANCE PURPOSE NOT FOR REFERENCE

1. SRIKRUPA INISTITUTE OF PHARMACEUTICAL SCIENCES
(Approved by AICTE; PCI)
(Affiliated to Osmania University)
ASSIGNMENT ON
OVERVIEW OF ICH GUIDELINES
SUBMITTED BY
HUZAIFA NAAZ
OVERVIEW OF ICH GUIDELINES: QSEM
ICH is the “International Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use”
Objectives of ICH
• To increase international harmonization of technical requirements to ensure that safe, effective
and high quality medicines are developed.
• To harmonize technical requirements for registration or marketing approval.
• To develop and register pharmaceuticals in the most efficient and cost effective manner.
• To promote public health.
• To prevent unnecessary duplication of clinical trials on humans.
• To minimize the use of animal testing without compromising safety and effectiveness of drug.
QSEM:
Q:"Quality" Topics, i.e., those relating to chemical and pharmaceutical Quality Assurance (Stability
Testing, Impurity Testing, etc.)
S: “Safety” Topics, i.e., those relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing,
Genotoxicity Testing, etc.)
E: “Efficacy” Topics, i.e., those relating to clinical studies in human subject (Dose Response Studies,
Good Clinical Practices, etc.)
M: “Multidisciplinary” Topics, i.e., cross-cutting Topics which do not fit uniquely into one of the above
categories.
Quality Guidelines "Quality" Topics, i.e., those relating to chemical and pharmaceutical Quality
Assurance (Stability Testing, Impurity Testing, etc.):

2. Q1: stability:
Q1 (A): Stability Testing of New Drug Substances and Products.
Q1B: 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 •
Q2-Analytical validation
Q2A: Validation of Analytical Procedures: Text and Methodology
Q3: impurities:
Q3A: Impurities in New Drug Substances
Q3B: Impurities in New Drug Products
Q3C: Impurities: Guideline for Residual Solvents
Q4: Pharmacopoeias:
Q4A: Pharmacopoeial Harmonization
Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Q5: Quality of biotechnological products:
Q5A: 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: 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
Q6: Specifications for New Drug Substances and Products
Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug
Products
Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Q8: Pharmaceutical Development
Q9: Quality Risk Management
Q10: Pharmaceutical Quality System
Status of Safety Topics Safety" Topics, i.e., those relating to in vitro and in vivo pre-clinical studies
(Carcinogenicity Testing, Genotoxicity Testing, etc.)
S1: Carcinogenicity studies:
S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals
S1B: Testing for Carcinogenicity of Pharmaceuticals
S1C: Dose Selection for Carcinogenicity Studies of Pharmaceuticals

3. S2– Genotoxicity:
S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals
S3: Toxicokinetics and Pharmacokinetics:
S3A: Note for Guidance on Toxicokinetics
S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing)
S5: Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility
S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
S7A: Safety Pharmacology Studies for Human Pharmaceuticals
S7B: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval
Prolongation) By Human Pharmaceuticals
S8: Immunotoxicity Studies for Human Pharmaceuticals
S9: Nonclinical Evaluation for Anticancer Pharmaceuticals
fficacy Guidelines Efficacy" Topics, i.e., those relating to clinical studies in human subject (Dose
Response Studies, Good Clinical Practices, etc.)
E1-E2F---CLINICAL SAFETY:
E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long- Term
Treatment of Non-Life-Threatening Conditions
E2A: Clinical Safety Data Management: Definitions and Standards
E2B: Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports
E2C: Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
E2D: Post-Approval Safety Data Management: Definitions and Standards
E2E: Pharmacovigilance Planning
E2F: Development Safety Update Report
E3: Structure and Content of Clinical Study Reports
E4: Dose-Response Information to Support Drug Registration
E5: Ethnic Factors in the Acceptability of Foreign Clinical Data
E6: Good Clinical Practice
E7-E11----CLINICAL TRIALS:
E7: Studies in Support of Special Populations: Geriatrics
E8: General Considerations for Clinical Trials
E9: Statistical Principles for Clinical Trials
E10: Choice of Control Group and Related Issues in Clinical Trials
E11: Clinical Investigation of Medicinal Products in the Pediatric Population
E12-Guidelines for Clinical Evaluation by Therapeutic Category
E13: Principles for Clinical Evaluation of New Antihypertensive Drugs
E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Pro-Arrhythmic Potential for Non-
Antiarrhythmic Drugs

4. E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and
Sample Coding Categories
E16: Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification
Submissions
Multidisciplinary Guidelines "Multidisciplinary" Topics, i.e., Topics which do not fit uniquely into one of
the above categories (MedDRA, ESTRI, M3, CTD, M5) 81
M1: Medical Terminology
M2: Electronic Standards for Transmission of Regulatory Information (ESTRI)
M3: Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing
Authorization for Pharmaceuticals
M4: The Common Technical Document
M5: Data Elements and Standards for Drug Dictionaries