overviewon ICH guidelines


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ICH GUIDELINES Presented By: Asra Parveen ( M.Pharm ) DECCAN SCHOOL OF PHARMACY Dar-us- salam , Aghapura , Hyderabad- 01. A.P. India


What is ICH I nternational C onference On H armonization 2


The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) It is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. INTRODUCTION 3

Mongolian Baiti:

Need to Harmonize Avoid duplication in tests to conform to different regulatory guidelines. More effective utilization of results. Timely access of patients to safe and effective new drugs. Promote public health. Minimize animal testing without compromising safety & effectiveness. 4


Objectives 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 developed and registered 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. 5


Where is the ICH located? ICH does not have "offices" as such because it is a voluntary cooperative effort of cosponsors from the three regions. The ICH Secretariat is based in Geneva. The biennial meetings and conferences of the ICH Steering Committee rotate between the EU, Japan, and the USA. 6


Current Status of Harmonization: (over 50 harmonized guidelines) Safety (S) Dealing with in vitro & in vivo pre clinical testing Quality (Q) Chemical & Pharmaceutical QA Stability, Specifications, Analytical Efficacy (E) Clinical studies in humans Multidisciplinary (M) Terminology Electronic standards Common Technical Documents The topics 7

What is ICH:

Safety Guidelines(animal studies/Pre clinical studies ) Carcinogenicity Studies Genotoxicity Studies Toxicokinetics and Pharmacokinetics Toxicity Testing Reproductive Toxicology Biotechnological Products Pharmacology Studies Immunotoxicology Studies Joint Safety/Efficacy  (Multidisciplinary) Topic 8

PowerPoint Presentation:

Carcinogenicity Studies S1A Need for Carcinogenicity Studies of Pharmaceuticals S1B Testing for Carcinogenicity of Pharmaceuticals S1C(R2) New title: Dose Selection for Carcinogenicity Studies of Pharmaceuticals & Limit Dose Genotoxicity Studies S2(R1) Guidance on genotoxicity testing & data interpretation of pharmaceuticals intended for human use. S2A Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals S2B Genotoxicity : A Standard Battery for Genotoxicity Testing of Pharmaceuticals 9

Need to Harmonize:

Toxicokinetics and Pharmacokinetics S3A Note for Guidance on Toxicokinetics : The Assessment of Systemic Exposure in Toxicity Studies S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies Toxicity Testing S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) S5(R2) New title: Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals 10


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 S8 Immunotoxicity Studies for Human Pharmaceuticals S9 Non-Clinical evaluation for anticancer Pharmaceuticals 11

Where is the ICH located?:

Quality Topics (manufacturing) Those relating to chemical and pharmaceutical Quality Assurance Stability Analytical Validation Impurities Pharmacopoeias Quality of Biotechnological Products Specifications Good Manufacturing Practice Pharmaceutical Development Quality Risk Management 12

Current Status of Harmonization: (over 50 harmonized guidelines) :

Stability Q1A(R2) Stability Testing of New Drug Substances and Products Q1B Stability Testing : Photo stability 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 13

Safety Guidelines(animal studies/Pre clinical studies ):

Analytical Validation Q2(R1) New title: Validation of Analytical Procedures: Text and Methodology Q3A(R2) Impurities in New Drug Substances Q3B(R2) Impurities in New Drug Products Q3C(R3) Impurities: Guideline for Residual Solvents Impurities 14

Carcinogenicity Studies :

Pharmacopoeias Q4 Pharmacopoeias Q4A Pharmacopoeia Harmonization Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) Quality of Biotechnological Products Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5B Quality of Biotechnological Products : 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 15

Toxicokinetics and Pharmacokinetics :

Specifications Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (including Decision Trees) Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products 16

Pharmacology Studies :

Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q8 Pharmaceutical Development Q9 Quality Risk Management Q10 Pharmaceutical Quality System 17

Quality Topics (manufacturing) Those relating to chemical and pharmaceutical Quality Assurance:

Efficacy guidelines (Clinical studies) Clinical Safety Clinical Study Reports Dose-Response Studies Ethnic factors Good Clinical Practice Clinical Trials on special population Guidelines for Clinical Evaluation by Therapeutic Category Clinical Evaluation-( statistical consideration) Pharmacogenomics 18

Stability :

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 for Expedited Reporting E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports E2C(R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2E Pharmacovigilance Planning 19

Analytical Validation :

E3 Structure and Content of Clinical Study Reports E4 Dose-Response Information to Support Drug Registration E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data E6(R1) Good Clinical Practice 20


Clinical Trials E7 Studies in Support of Special Populations: Geriatrics E8 General Consideration of 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 21

PowerPoint Presentation:

E12 Principles for Clinical Evaluation of New Antihypertensive Drugs E14 The Clinical Evaluation of QT/ QTc Interval Prolongation and Proarrhythmic Potential for Non- Antiarrhythmic Drugs E15 Terminology in Pharmacogenomics E16 Genomic Biomarkers related to Drug Response 22

PowerPoint Presentation:

M "Multidisciplinary" Topics Cross-cutting Topics which do not fit uniquely into one of the above categories. M1: Medical Terminology (MedDRA) M2: Electronic Standards for Transmission of Regulatory Information (ESTRI) M3: Timing of Pre-clinical Studies in Relation to Clinical Trials M4: The Common Technical Document (CTD) M5: Data Elements and Standards for Drug Dictionaries 23

Efficacy guidelines (Clinical studies):

The Impact of ICH Enhanced patient safety Streamline development programs Common quality standards Reduce resource requirements Forum for communication Opportunity for industry & regulators to sit across the table Discuss drug development procedure with a common goal of identifying best scientific practice & applying the same uniformly across the globe 24

Clinical Safety :

CONCLUSION The ICH guidelines represent agreed-upon scientific guidance for meeting technical requirements for registration within the three ICH regions - EU, US and Japan. Industry and governments in ICH and non-ICH countries can use the ICH guidelines to address technical issues during the product development process. Harmonised ICH guidelines can reduce duplication in meeting technical requirements, thereby saving financial and material resources.         25

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