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ICH GUIDELINES HEMANTH KUMAR G

Objectives of ICH::

“International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.” Objectives of ICH: To improve efficiency of new drug development and registration Process To promote public health, prevent duplication of clinical trials in humans and minimize the use of animal testing without compromising safety and effectiveness

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History: Thalidomide incident in Europe in 1960’s. In 1980’s – Europe, Japan and US discussed on possibilities of harmonization. Birth of ICH took place in April 1990 at Brussels. First decade – development of safety, quality and efficacy and works on MedDRA (Medical Dictionary for Regulatory Activities) and the CTD (Common Technical Document) Second decade – maintain and implement guidelines; collaboration with Standards Development Organisations .

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Organization of ICH Steering committee ICH working groups Global Co-operation Group MedDRA Management Board Secretariat Coordinators

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Region Regulating body Research based industry Japan MHLW - Ministry of Health, Labour and Welfare JPMA - Japan Pharmaceutical Manufacturers Association Europe EU -European Union EFPIA - European Federation of Pharmaceutical Industries& Associations USA FDA- Food and Drug Administration PhRMA - Pharmaceutical Research and Manufacturers of America ICH Observers include the World Health Organization (WHO), European Free Trade Association (EFTA), and Canada.

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Formal ICH procedure Q & A procedure Revision procedure Maintenance procedure Content of an existing ICH Guideline out of date or no longer valid? New topic for harmonisation of ICH? New information to be added to an existing ICH Guideline? Change to be made to either Q3C Guideline or M2 Recommendations? Process of Harmonisation Clarification needed for existing ICH Guideline? Concept Paper & Business Plan required Concept Paper required (Business Plan may be required in certain cases) Concept Paper required Proposal/Concept Paper required for Q3C maintenance. No Concept Paper required for M2 Recommendations maintenance

A)Formal ICH procedure:

A)Formal ICH procedure Consensus building Confirmation of six-party consensus Regulatory consultation and Discussion Adoption of an ICH Harmonised Tripartite Guideline Implementation Step 1 Step 2 Step 3 Step 4 Step 5

b) Q&As Procedure Followed when additional guidance is considered necessary to help the interpretation of certain ICH harmonised tripartite Guidelines and ensure a smooth and consistent implementation in the ICH regions and beyond. The IWG works to reach consensus on a draft Q&A document and makes a recommendation to the SC on whether the document should be a Step 2 or a Step 4. This recommendation is based on the level of information provided by the answers. The document then follows the normal path of a Step 2/Step 4 Document as per the Formal ICH Procedure.:

b) Q&As Procedure Followed when additional guidance is considered necessary to help the interpretation of certain ICH harmonised tripartite Guidelines and ensure a smooth and consistent implementation in the ICH regions and beyond. The IWG works to reach consensus on a draft Q&A document and makes a recommendation to the SC on whether the document should be a Step 2 or a Step 4. This recommendation is based on the level of information provided by the answers. The document then follows the normal path of a Step 2/Step 4 Document as per the Formal ICH Procedure.

d)Maintenance Procedure : The Maintenance Procedure is currently applicable only for changes to the Q3C Guideline on Impurities: Residual Solvents and M2 Recommendations. In each case the procedure is used when there is new information to be added or the scientific/technical content is out-of-date or no longer valid. :

d)Maintenance Procedure : The Maintenance Procedure is currently applicable only for changes to the Q3C Guideline on Impurities: Residual Solvents and M2 Recommendations. In each case the procedure is used when there is new information to be added or the scientific/technical content is out-of-date or no longer valid. c)Revision Procedure: Almost identical to the Formal ICH Procedure only difference is that the final outcome is a revised version of an existing Guideline, rather than a new Guideline. The revision of a Guideline is designated by R1 . When a Guideline is revised more than once, the document will be named R2, R3, R4, etc at each new revision.

ICH GUIDEILINES:

ICH GUIDEILINES

ICH-Quality Guidelines:

ICH-Quality Guidelines Q1 : STABILITY Q2 : ANALYTICAL VALIDATION Q3 : IMPURITIES Q4 : PHARMACOPOEIAS Q5 : BIOTECHNOLOGICAL QUALITY Q6 : SPECIFICATIONS Q7 : GMP Q8 : PHARMACEUTICAL DEVELOPMENT Q9 : QUALITY RISK MANAGEMANT Q10 : PHARMACEUTICAL QUALITY SYSTEM

Q1 Stability testing :

Q1 Stability testing 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 for Stability Data Q1F -Stability Data Package for Registration Applications in Climatic Zones III and IV

Q2 Validation:

Q2 Validation Q2(R1) Validation of Analytical Procedures: Text and Methodology Q2A Text on Validation of Analytical Procedures Q2B Validation of Analytical Procedures: Methodology Q3 Impurities Q3A(R2) Impurities In New Drug Substances Q3B(R2) Impurities in New Drug Products Q3C(R5) Impurities: Guideline for Residual Solvents

Q4-Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonization Regions :

Q4-Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonization Regions Annex I: Residue on Ignition/Sulphated Ash General Chapter Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter Annex 4A : Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter

Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter   Annex 5: Disintegration Test General Chapter Annex 6: Uniformity of Dosage Units General Chapter Annex 7: Dissolution Test General Chapter Annex 8: Sterility Test General Chapter :

Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter Annex 5: Disintegration Test General Chapter Annex 6: Uniformity of Dosage Units General Chapter Annex 7: Dissolution Test General Chapter Annex 8: Sterility Test General Chapter

Annex 9: Tablet Friability General Chapter Annex 10: Polyacrylamide Gel Electrophoresis General Chapter Annex 11: Capillary Electrophoresis General Chapter Annex 12: Analytical Sieving General Chapter :

Annex 9: Tablet Friability General Chapter Annex 10: Polyacrylamide Gel Electrophoresis General Chapter Annex 11: Capillary Electrophoresis General Chapter Annex 12: Analytical Sieving General Chapter

Q5 BIOTECHNOLOGICAL QUALITY:

Q5 BIOTECHNOLOGICAL QUALITY 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 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

Q6 SPECIFICATIONS:

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

Q7A GMP Guidance for APIs :

Q7A GMP Guidance for APIs This document is intended : To provide guidance regarding GMP for manufacturing of API under an appropriate system for managing quality To ensure that API meets the requirements of quality and purity Q8(R2) Pharmaceutical Development To design a quality product and its manufacturing process to consistently deliver the intended performance of the product

Q10 Pharmaceutical Quality System Q11Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) :

Q9 Quality Risk Management It provides principles and examples of tools for Quality Risk Management that can be applied to different aspects of pharmaceutical quality such as : Development Manufacturing Distribution Inspection Q10 Pharmaceutical Quality System Q11Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

Multidisciplinary Guidelines:

Multidisciplinary Guidelines M3(R2) Implementation working group M3(R2) guideline: guidance on non clinical safety studies for conduct of human clinical trails and marketing authorization for pharmaceuticals M2(R2) Electronic transmission of individual case safety reports message specification(ICH ICSR DTD VERSION 2.1)

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M4 Organization of the common technical document for the registration of pharmaceuticals for human use M4E(R1) The common technical document for the registration of pharmaceuticals for human use efficacy M4Q(R1) The common technical document for the registration of pharmaceuticals for human use :Quality Quality overall summary of module 2,module 3 : Quality M4S(R2) The common technical document for the registration of pharmaceuticals for human use safety Non clinical overview and non clinical summaries of module 2,organization of module 4

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Safety Guidelines S1A Need for Carcinogenicity Studies of Pharmaceuticals S1B Testing for Carcinogenicity of Pharmaceuticals S1C-R2 Dose Selection for Carcinogenicity Studies of Pharmaceuticals S2-R1 Guidance On Genotoxicity Testing And Data Interpretation For Pharmaceuticals Intended For Human Use S3A Note For Guidance On Toxicokinetics:The Assessment Of Systemic Exposure In Toxicity Studies

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S3B Pharmacokinetics: Guidance For Repeated Dose Tissue Distribution Studies S4 Duration Of Chronic Toxicity Testing In Animals (Rodent And Non Rodent Toxicity Testing) S5-R2 Detection Of Toxicity To Reproduction For Medicinal Products & Toxicity To Male Fertility S6 Addendum To ICH S6: Preclinical Safety Evaluation Of Biotechnology-derived Pharmaceuticals S7A Safety Pharmacology Studies for Human Pharmaceuticals

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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 Nonclinical Evaluation for Anticancer Pharmaceuticals S10 Photo safety Evaluation of Pharmaceuticals

Efficacy Guidelines:

Efficacy Guidelines Clinical Safety E1-E2F Clinical Study Reports E3 Dose Response Studies E4 Ethnic Factors E5 Good Clinical Practice E6 Clinical Trials E7-E11 Guidelines for Clinical Evaluation by Therapeutic Category E12 Clinical Evaluation E14 Pharmacogenomics E15-E16 Joint Safety / Efficacy Topic M3

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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 E2A E2B-R2 Maintenance Of The ICH Guideline On 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

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E2D Post Approval Safety Data Management: Definitions and Standards for Expedited Reporting 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 R1 Ethnic Factors In The Acceptability Of Foreign Clinical Data E5 R1 Ethnic Factors In The Acceptability Of Foreign Clinical Data

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E6-R1 Good Clinical Practice 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 Principles for Clinical Evaluation of New antihypertensive Drugs

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E14 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. E15 Definitions For Genomic Biomarkers, Pharmaco- genomics, Pharmacogenetics, Genomic Data And Sample Coding Categories E16 Biomarkers Related To Drug Or Biotechnology Product Development: Context, Structure And Format Of Qualification Submissions M3 R2 Guidance On Non-clinical Safety Studies For The Conduct Of Human Clinical Trials And Marketing Authorization For Pharmaceuticals

References::

References: http://www.ich.org/

THANK YOU:

THANK YOU