Ich

1. ICH BY B.RAMESH 256212886036 MRCP

2. CONTENTS WHAT IS ICH IMPACT OF ICH OBJECTIVES STRUCTURE OR ORGANIZATION GUIDELINES REFERENCES

3. WHAT IS ICH? The term ICH is international conference on hormonisation of technical requirements for registration of pharmaceuticals for human use. The ICH was born in april 1990 in a meeting hosted by EFPIA in Brussels. The meeting was attended by representatives from Japan, u.s , European union.

4. . This meeting was mainly to harmonize several processes and the actions that are performed during the development process of a drug. Harmonization has several benefits in promoting public health as it helps to avoid or eliminate the need for unnecessary repetition of clinical trials in humans, minimizes the need for animal testing without compromising on the safety and efficacy of the drug. It also reduces the time and resources required for the new drug development.

5. IMPACT OF ICH Enhanced patient safety Streamline development programs Common quality standards Reduce resource requirements Forum for communication Discuss drug development procedure with a common goal of identifying best scientific practice & applying the same uniformity across the globe

6. 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.

7. Contd … 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.

8. STRUCTURE OR ORGANIZATION Steering Committee: The ICH Steering Committee (SC) is the governing body that oversees the harmonization activities. Since its establishment in 1990, each of its six co-sponsors (EU, EFPIA, MHLW, JPMA, FDA, PhRMA ) Other parties have a significant interest in ICH and have been invited to nominate Observers to the SC.

9. . The three Observers are the World Health Organization (WHO), Health Canada(HC) and the European Free Trade Association (EFTA).

10. The ICH receives support from the following organizations: European commission(EC) European federation of pharmaceutical industries and association(EFPIA) Ministry of health, labour and welfare(MHLW) Japan pharmaceutical manufacturers association(JPMA) Food and drug administration(FDA) Pharmaceutical research and manufacturers of America(Ph RMA) World Health Organization (WHO)

11. EC/European commission :  The European Commission represents the 27 members of the EU . The Commission works through harmonization of legislation and technical requirements and procedures, to achieve a single market in pharmaceuticals to allow free movement of products throughout the EU.

12. EFPIA : EFPIA is situated in Brussels and has, as its members, 31 national pharmaceutical industry associations and 40 leading pharmaceutical companies involved in the research, development and manufacturing of medicinal products in Europe for human use. Much of the Federation's work is concerned with the activities of the European Commission and the European Medicines Agency

13. MHLW : Ministry of Health, Labour and Welfare is a Technical and scientific support for ICH activities are provided by the Pharmaceuticals and Medical Devices Agency (Ph MDA) and by the National Institute of Health Sciences (NIHS) and others

14. JPMA : Japan Pharmaceutical Manufacturers Association (JPMA) ICH work is coordinated through the specialized committee of experts from JPMA companies.

15. FDA / US Food and Drug Administration :  The US Food and Drug Administration (FDA) has a wide range of responsibilities for drugs, biological , medical devices, cosmetics and radiological products. The largest of the world's drug regulatory agencies FDA is responsible for the approval of all drug products used in the US

16. PhRMA :  The Pharmaceutical Research and Manufacturers of America - PhRMA - represents the research-based industry in the USA. The Association has 67 companies in membership which are involved in the discovery, development and manufacture of prescription medicines. There are also 24 research affiliates which conduct biological research related to the development of drugs and vaccines

17. Secretariat :  The ICH Secretariat is located in Geneva, Switzerland. Its staff is responsible for day-to-day management of ICH, namely preparations for, and documentation of, meetings of the Steering Committee and its Working Groups. The ICH Secretariat also provides administrative support for the ICH Global Coordination Group and the ICH MedDRA Management Board

18. Coordinators :  Coordinators ensure proper distribution of ICH documents to the appropriate persons from their party (SC members, Topic Leaders, Experts) and are responsible for proper follow up on actions by their respective party within assigned deadlines.

19. Working groups :  There are several different types of ICH working groups that can be EWG: (Expert Working Group) is charged with developing a harmonized guideline that meets the objectives in the Concept Paper and Business Plan. IWG: (Implementation Working Group) is tasked to develop Q&As to facilitate implementation of existing guideline

20. 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

21. Safety Guidelines Carcinogenicity Studies Genotoxicity Studies Toxic kinetics and Pharmacokinetics Toxicity Testing Reproductive Toxicology Biotechnological Products Studies Immuno toxicology Studies

22. 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

23. 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

24. Toxico kinetics 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

25. 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

26. Pharmacology Studies S7A Safety Pharmacology Studies for Human Pharmaceuticals S7B The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization by Human Pharmaceuticals S8 Immuno toxicity Studies for Human Pharmaceuticals S9 Non-Clinical evaluation for anticancer Pharmaceuticals

27. Quality Guidelines Stability Analytical Validation Impurities Pharmacopoeias Quality of Biotechnological Products Specifications Good Manufacturing Practice Pharmaceutical Development Quality Risk Management

28.  Stability Q1A 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

29. Q1E Evaluation of Stability Data Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV

30. IMPURITIES Q3A(R2) Impurities in New Drug Substances Q3B(R2) Impurities in New Drug Products Q3C(R2) Impurities: Guideline for Residual Solvents Impurities

31. Pharmacopoeias Q4 Pharmacopoeias Q4A Pharmacopoeia Harmonization Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC)

32. Quality of Biotechnological Products Q5A 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

33. 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 Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

34. Q8 Pharmaceutical Development Q9 Quality Risk Management Q10 Pharmaceutical Quality System

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

36. 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 Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports

37. E2C 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

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

39. 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

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

41. Multidisciplinary Guidelines 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

42. References http://www.ich.org/products/guidelines.html www.fda.gov/regulatoryinformation/guidances/ucm122049.html 70 www.ich.org www.google.co.in

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