ich guidelines
TRANSCRIPT
ICH GUIDELINES
ABDULAZIZ D. DUKANDARM.PHARM. (Q.A.) 1ST SEM.
PARUL INSTITUTE OF PHARMACY, BARODA
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ICHINTERNATIONAL CONFERENCE ON
HARMONIS/ZATION of Technical Requirements for the Registration of
Pharmaceuticals for Human
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ICHThe International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has evolved, through its ICH Global Cooperation Group, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.
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QUALITY“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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Q1: STABILITYQ2(R1): ANALYTICAL VALIDATION[Text and Methodology]Q3: IMPURITIESQ4: PHARMACOPOEIAQ5: QUALITY OF BIOTECHNOLOGICAL PRODUCTSQ6: SPECIFICATIONSQ7: GOOD MANUFACTURING PRACTICES [Guide for Active Pharmaceutical Ingredients]Q8(R2): PHARMACETICAL DEVELOPMENTQ9: QUALITY RISK MANAGEMENTQ10: PHARMACEUTICAL QUALITY SYSTEMQ11: DEVELOPMENT & MANUFACTURE OF DRUG SUBSTANCES [Chemical Entities and Biotechnological/Biological Entities]
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Q1: 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
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Q3: IMPURITIES 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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Q4: PHARMACOPOEIA Q4A: Pharmacopoeial Harmonization Q4B: Evaluation and Recommendation
of Pharmacopoeial Texts for Use in the ICH Regions
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Q5: QUALITY OF BIOTECHNOLOGICAL PRODUCTS Q5A(R1): 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 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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Q6: SPECIFICATIONS 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
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SAFETY“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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Carcinogenicity Studies S1A - S1C Genotoxicity Studies S2 Toxicokinetics and Pharmacokinetics
S3A - S3B Toxicity Testing S4 Reproductive Toxicology S5 Biotechnological Products S6 Pharmacology Studies S7A - S7B Immunotoxicology Studies S8 Nonclinical Evaluation for Anticancer
Pharmaceuticals S9 Photo safety Evaluation S10
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S1: 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
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S3: TOXICOKINETICS & PHARMACOKINETICS S3A: Note for Guidance on
Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
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S7: 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
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EFFICACY“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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Clinical Safety E1 - E2F Clinical Study Reports E3 Dose-Response Studies E4 Ethnic Factors E5 Good Clinical Practice E6 Clinical Trials E7 - E11 Clinical Evaluation by Therapeutic
Category E12 Clinical Evaluation E14 Pharmacogenomics E15 - E16
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E1-E2 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
E2B:(R3) 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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E7-E11 CLINICAL TRIALS 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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E15-E16 PHARMACOGENOMICS 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
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MULTIDISCIPLINARY“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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MedDRA Terminology M1 Electronic Standards M2 Nonclinical Safety Studies M3 Common Technical Document M4 Data Elements and Standards for
Drug Dictionaries M5 Gene Therapy M6 Genotoxic Impurities M7 Electronic Common Technical
Document (eCTD) M8
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