ICH GUIDELINES

("International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use")

ICH Stability Zones

India comes under 4th zone. (4a zone particularly).

1. Quality Guidelines

Stability Q1A - Q1F

Stability Testing of New Drug Substances and Products Stability Testing : Photostability Testing of New Drug Substances and Products Stability Testing for New Dosage Forms Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Evaluation of Stability Data Stability Data Package for Registration Applications in Climatic Zones III and IV

Analytical Validation Q2
Q2(R1)

Validation of Analytical Procedures: Text and Methodology

Impurities Q3A - Q3D

Impurities in New Drug Substances Impurities in New Drug Products Impurities: Guideline for Residual Solvents Impurities: Guideline for Metal Impurities

Pharmacopoeias Q4 - Q4B
Q4 Q4A Q4B Q4B Annex 1R1 Q4B Annex 2R1

Pharmacopoeias Pharmacopoeial Harmonisation Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Residue on Ignition/Sulphated Ash General Chapter Test for Extractable Volume of Parenteral Preparations General

Q4B Annex 3R1 Q4B Annex 4AR1 Q4B Annex 4BR1 Q4B Annex 4CR1

Q4B Annex 5R1 Q4B Annex 6R1 Q4B Annex 7R2 Q4B Annex 8R1 Q4B Annex 9R1 Q4B Annex 10R1 Q4B Annex 11 Q4B Annex 12 Q4B Annex 13 Q4B Annex 14

Chapter Test for Particulate Contamination: Sub-Visible Particles General Chapter Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter Disintegration Test General Chapter Uniformity of Dosage Units General Chapter Dissolution Test General Chapter Sterility Test General Chapter Tablet Friability General Chapter Polyacrylamide Gel Electrophoresis General Chapter Capillary Electrophoresis General Chapter Analytical Sieving General Chapter Bulk Density and Tapped Density of Powders General Chapter Bacterial Endotoxins Test General Chapter

Quality of Biotechnological Products Q5A - Q5E

Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products Stability Testing of Biotechnological/Biological Products Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Pharmaceutical Development Q8/Q9/Q10 - Implementation

Specifications Q6A- Q6B

Q6B

Good Manufacturing Practice Q7

Pharmaceutical Development Q8
Q8(R2) Q8/9/10 Q&AsR4

Quality Risk Management Q9

Quality Risk Management Q8/Q9/Q10 - Implementation Pharmaceutical Quality System Q8/Q9/Q10 - Implementation

Pharmaceutical Quality System Q10

Development and Manufacture of Drug Substances Q11

Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

Cross-cutting Topics
Some ICH Products do not fit uniquely into one of the Quality, Safety or Efficacy categories. Those Products can be found under the Mulidisciplinary Section.

2. Safety Guidelines
Carcinogenicity Studies S1A - S1C
S1 S1A S1B S1C(R2)

NEW TOPIC: Rodent Carcinogenicity Studies for Human Pharmaceuticals Need for Carcinogenicity Studies of Pharmaceuticals Testing for Carcinogenicity of Pharmaceuticals Dose Selection for Carcinogenicity Studies of Pharmaceuticals

Genotoxicity Studies S2
S2(R1)

Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use

Toxicokinetics and Pharmacokinetics S3A - S3B

Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)

Toxicity Testing S4
S4

Reproductive Toxicology S5
S5(R2)

Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility

Biotechnological Products S6
S6(R1)

Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Safety Pharmacology Studies for Human Pharmaceuticals The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals

Pharmacology Studies S7A - S7B

Immunotoxicology Studies S8
S8

Immunotoxicity Studies for Human Pharmaceuticals

Nonclinical Evaluation for Anticancer Pharmaceuticals S9

Nonclinical Evaluation for Anticancer Pharmaceuticals

Photosafety Evaluation S10

Photosafety Evaluation of Pharmaceuticals

Cross-cutting Topics
Some ICH Products do not fit uniquely into one of the Quality, Safety or Efficacy categories. Those Products can be found under the Mulidisciplinary Section.

3. Efficacy Guidelines
Clinical Safety E1 - E2F
E1

E2A E2B(R2)

E2B(R3) E2C(R1) E2C(R2) E2D E2E E2F

The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions Clinical Safety Data Management: Definitions and Standards for Expedited Reporting Maintenance of the Clinical Safety Data Management including Data Elements for Transmission of Individual Case Safety Reports Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs Periodic Benefit-Risk Evaluation Report Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting Pharmacovigilance Planning Development Safety Update Report

Clinical Study Reports E3

Structure and Content of Clinical Study Reports Questions & Answers: Structure and Content of Clinical Study Reports

Dose-Response Studies E4
E4

Dose-Response Information to Support Drug Registration

Ethnic Factors E5
E5(R1) E5 Q&As (R1)

Ethnic Factors in the Acceptability of Foreign Clinical Data Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data

Good Clinical Practice E6

Good Clinical Practice

Clinical Trials E7 - E11

Studies in Support of Special Populations: Geriatrics Questions & Answers: Studies in Support of Special Populations : Geriatrics General Considerations for Clinical Trials Statistical Principles for Clinical Trials Choice of Control Group and Related Issues in Clinical Trials Clinical Investigation of Medicinal Products in the Pediatric Population

Clinical Evaluation by Therapeutic Category E12

Principles for Clinical Evaluation of New Antihypertensive Drugs Clinical Evaluation E14
E14 E14 Q&As R1

The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for NonAntiarrhythmic Drugs

Pharmacogenomics E15 - E16

E16

Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions

Cross-cutting Topics
Some ICH Products do not fit uniquely into one of the Quality, Safety or Efficacy categories. Those Products can be found under the Mulidisciplinary Section.

4.Multidisciplinary
Guidelines
MedDRA Terminology M1
MedDRA

Medical Dictionary for Regulatory Activities

Electronic Standards M2
ESTRI

Electronic Standards for the Transfer of Regulatory Information

Nonclinical Safety Studies M3

M3(R2) Q&As R2

Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals Questions & Answers: Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

Common Technical Document M4

The Common Technical Document

Data Elements and Standards for Drug Dictionaries M5

Data Elements and Standards for Drug Dictionaries

Gene Therapy M6
M6

Virus and Gene Therapy Vector Shedding and Transmission

Genotoxic Impurities M7
M7

Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

Electronic Common Technical Document (eCTD) M8 Electronic Common Technical Document (eCTD) CTD Quality Implementation Working Group