ICH Guidelines

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Recent Changes in ICH Guidelines

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Presentation on ICH GUIDELINES:

Presentation on ICH GUIDELINES Presented by YAJNESH PAI M.PHARMACY 1 ST YEAR AL-AMEEN COLLEGE OF PHARMACY, BANGALORE 1

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ICH means I NTERNATIONAL C ONFERENCE ON H ARMONISATION OF T ECHNICAL R EQUIREMENTS FOR R EGISTRATION OF P HARMACEUTICALS FOR H UMAN U SE.

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ICH The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories . The four categories are : Quality Guidelines Safety Guidelines Efficacy Guidelines Multi Disciplinary Guidelines

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ICH Quality Guidelines : Harmonization achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP ) risk management .

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ICH Quality Guidelines include : Stability Analytical Validation Impurities Pharmacopoeias Quality of Biotechnological Products Specifications Good Manufacturing Practices Pharmaceutical Management Quality Risk Management

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ICH These include : Stability Q1A - Q1F • 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 Martyring 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

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ICH Analytical Validation Q2 Q2(R1) Validation of Analytical Procedures: Text and Methodology Impurities Q3A - Q3D Q3A(R2) Impurities in New Drug Substances Q3B(R2) Impurities in New Drug Products Q3C(R5) Impurities: Guideline for Residual Solvents Q3D Impurities: Guideline for Elemental Impurities

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ICH Pharmacopoeias Q4 - Q4B Q4 Pharmacopoeias Q4A Pharmacopoeia Harmonization Q4B Evaluation and Recommendation of Pharmacopoeia Texts for Use in the ICH Regions Q4B Annex 1R1Residue on Ignition/Sulphated Ash General Chapter Q4B Annex 2R1Test for Extractable Volume of Parenteral Preparations General Chapter Q4B Annex 3R1Test for Particulate Contamination: Sub-Visible Particles General Chapter Q4B Annex 4AR1Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter Q4B Annex 4BR1Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter Q4B Annex 4CR1Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter Q4B Annex 5R1Disintegration Test General Chapter Q4B Annex 6R1Uniformity of Dosage Units General Chapter Q4B Annex 7R2Dissolution Test General Chapter Q4B Annex 8R1Sterility Test General Chapter Q4B Annex 9R1Tablet Friability General Chapter Q4B Annex 10R1Polyacrylamide Gel Electrophoresis General Chapter Q4B Annex 11Capillary Electrophoresis General Chapter Q4B Annex 12Analytical Sieving General Chapter Q4B Annex 13Bulk Density and Tapped Density of Powders General Chapter Q4B Annex 14Bacterial Endotoxins Test General Chapter Q4B FAQs Frequently Asked Questions

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ICH Quality of Biotechnological Products Q5A - Q5E Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal OriginQ5A 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 Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process

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ICH Specifications 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 Q7 Q7 Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsQ7A Q7 Q&As Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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ICH Pharmaceutical Development Q8 Q8(R2) Pharmaceutical Development Q8/9/10 Q&AsR4 Q8/Q9/Q10 - Implementation Quality Risk Management Q9 Q9 Quality Risk Management Q8/9/10 Q&AsR4 Q8/Q9/Q10 - Implementation

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ICH Pharmaceutical Quality System Q10 Q10 Pharmaceutical Quality System Q8/9/10 Q&AsR4 Q8/Q9/Q10 - Implementation Development and Manufacture of Drug Substances Q11 Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Cross-cutting Topics Cross-cutting Guidelines

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ICH 2 . Safety Guidelines : ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.

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ICH Safety guidelines include : Carcinogenicity Studies Genotoxicity Studies Toxicokinetics & Pharmacokinetics Toxicity Testing Reproductive Toxicology Biotechnological Products Pharmacology Studies Immunotoxicology Studies

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ICH Carcinogenicity Studies S1A - S1C S1 NEW TOPIC: Rodent Carcinogenicity Studies for Human Pharmaceuticals S1A Need for Carcinogenicity Studies of Pharmaceuticals S1B Testing for Carcinogenicity of Pharmaceuticals S1C(R2) 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

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ICH Toxicokinetics and Pharmacokinetics S3A - S3B 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 S4 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)

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ICH 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 Pharmacology Studies S7A - S7B 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

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ICH Immunotoxicology Studies S8 S8 Immunotoxicity Studies for Human Pharmaceuticals Nonclinical Evaluation for Anticancer Pharmaceuticals S9 S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Photosafety Evaluation S10 S10 Photosafety Evaluation of Pharmaceuticals Cross-cutting Topics Cross-cutting Guidelines

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ICH 3 . Efficacy Guidelines : The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.

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ICH Efficacy guidelines include : Clinical Safety Clinical Study Reports Dose – Response Studies Good Clinical Practice Clinical Studies Clinical Evaluation by Therapeutics Category Clinical Evaluation Pharmacogenomics Cross – Cut Topics

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ICH Clinical Safety E1 - E2F 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 E2B(R3) IWG Implementation: Electronic Transmission of Individual Case Safety Reports E2C(R2) Periodic Benefit-Risk Evaluation Report E2C(R2) Q&As Questions & Answers: Periodic Benefit-Risk Evaluation Report E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2E Pharmacovigilance Planning E2F Development Safety Update Report

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ICH Clinical Study Reports E3 E3 Structure and Content of Clinical Study Reports E3 Q&As R1Questions & 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) Ethnic Factors in the Acceptability of Foreign Clinical Data E5 Q&As (R1)Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data

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ICH Good Clinical Practice E6 •E6(R1)Good Clinical Practice Clinical Trials E7 - E11 E7 Studies in Support of Special Populations: Geriatrics E7 Q&As Questions & Answers: 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

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ICH Clinical Evaluation by Therapeutic Category E12 E12 Principles for Clinical Evaluation of New Antihypertensive Drugs Clinical Evaluation E14 E14 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs E14 Q&As R1 Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non Antiarrhythmic Drugs

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ICH Pharmacogenomics E15 - E16 E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions Cross-cutting Topics Cross-cutting Guidelines

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ICH 4 . Multidisciplinary Guidelines : Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

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ICH Multidisciplinary Guidelines include : MedDRA (Medical Dictionary for Regulatory Activities) ESTRI (Electronic Standards for the Transfer of Regulatory Information ) Pre – Clinical Trials in relation to Clinical Trials eCTD (Electronic Common Technical Document) 5. Data Elements and Standard for Drug Dictionary

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ICH MedDRA Terminology M1 MedDRA Medical Dictionary for Regulatory Activities Electronic Standards M2 ESTRI Electronic Standards for the Transfer of Regulatory Information

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ICH Nonclinical Safety Studies M3 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 Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Common Technical Document M4 CTD The Common Technical Document.

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ICH Data Elements and Standards for Drug Dictionaries M5 M5Data Elements and Standards for Drug Dictionaries Gene Therapy M6 • M6Virus and Gene Therapy Vector Shedding and Transmission

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ICH Genotoxic Impurities M7 M7Assessment 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)

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