Origin and Principle of ICH(GCP) R2.pptx

This SlideShare presentation provides a comprehensive exploration of Good Clinical Practice (GCP) as established by the International Council for Harmonization (ICH). Beginning with an introduction to ICH GCP, it delves into the purpose and objectives behind its formation, emphasizing its role in ensuring ethical conduct and quality standards in clinical trials.

The presentation traces the initiation and evolution of ICH, detailing key milestones and the collaborative efforts of its global members. Highlighted are success stories that underscore ICH's pivotal role in harmonizing regulations and enhancing global clinical research standards.

A focal point of the presentation is the principles outlined in ICH GCP E6 (R2), which govern essential aspects such as patient safety, data integrity, and regulatory compliance. Practical applications and case studies illustrate these principles in action, offering valuable insights for healthcare professionals, researchers, and regulators alike.

Key Topics Covered:

1) Introduction to ICH GCP
2) Purpose and Objectives of ICH
3) Initiation and Evolution of ICH
4) Collaboration among ICH Members
5) Impact and Success Stories
6) Principles of ICH GCP E6 (R2): Ensuring Quality and Compliance
Practical Applications and Case Studies
Whether you're new to clinical research or seeking to deepen your understanding of global regulatory standards, this SlideShare presentation serves as a comprehensive guide to the evolution, principles, and impactful contributions of ICH GCP.

1. 1 Presented By: Akhilesh V. Tapase M Pharm (ll nd sem) Roll no:- MPL-14 Guided by : Dr. Pankaj Jain (Department of Pharmacology) R. C. Patel Institute of Pharmaceutical Education and Research,Shirpur ORIGIN AND PRINCIPLES OF ICH (GCP) Department of Pharmacology

2. CONTENT OF TOPIC INTRODUCTION PURPOSEOF ICH OBJECTIVES OF ICH INITIATION OF ICH EVOLUTION OF ICH MEMBERS OF ICH SUCCESS OF ICH PRINCIPLE OF ICH GCP E6 (R2) REFERENCES 2

3. INTRODUCTION The International Council on Harmonization’s Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together regulatory authorities of Europe, Japan, United States and experts from the pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product and registration. The birth of ICH took place at meeting in April 1990 in Brussels. The International Conference on Harmonisation has renamed itself as the International Council on Harmonisation on 23 October 2015. Reformed as a non-profit legal entity under Swiss Law on 23 October 2015  3

4. 4 PURPOSE OF ICH Promotion of public health through international harmonization that contributes to: Achieve greater harmonisation worldwide for the development and approval of safe, effective, and high-quality medicines in the most resource-efficient manner. Prevention of unnecessary duplication of clinical trials and post market clinical evaluations. Registration and supervision of new medicines. Reduction of unnecessary animal testing without compromising safety and effectiveness.

5. OBJECTIVES OF ICH 5

6. INITIATION OF ICH Harmonization of regulatory requirements was pioneered by European community (Now EU) in 1980s. Success achieved by Europe demonstrated that harmonisation was feasible. At same time there were bilateral discussions between Europe, Japan & US, on possibilities for harmonization. 6

7. EVOLUTION OF ICH Two decades of success, attributed by scientific agreements & the commitment between Industries and Regulatory parties. First decade saw significant progress in the development of tripartite, ICH guidelines on SAFETY, QUALITY & EFFICACY topics and also on MULTIDISCIPLINARY topics (MedDRA, CTD). Expanded communication & propagation of information on ICH guidelines with Non-ICH regions. Second decade was towards facilitating the implementation of ICH Guidelines in ICH and maintaining already existing ICH Guidelines. Est. Global cooperation Group (GCG) in response to a growing interest from beyond the ICH region in the use of ICH guidelines. 7

8. MEMBERS OF ICH 21 Members: 3-Founding Regulatory : 8 See for more details https://www.ich.org/page/members-observers EC, Europe MHLW/PMDA, Japan FDA, United States.

9. CONTINUE… 9 EFPIA JPMA PhRMA 2-Standing Regulatory : Swiss medic, Switzerland Health Canada, Canada 3-Founding Industry :

10. 10 MHRA, UK 10-Regulatory : 3-Industry :

11. CONTINUE… 11 2 Standing Observers: 37 Observers: Regulatory authorities. Regional Harmonization Initiatives. International industry pharmaceutical organizations. International organizations regulated or affected by ICH Guidelines. WHO IFPMA

12. COMPOSITION OF ICH WGS With over 700 technical experts in over 30 WGs – as of May 2023 12

13. ICH SUCCESSES Clinical trials conducted in one ICH region can be used in other ICH regions by setting the common standards on science and ethics. 13 GCP (Good Clinical Practice)

14. ICH SUCCESSES CTD/eCTD (Common Technical Document) 14 CTD brings together all Quality, Safety and Efficacy information in a common, harmonized format, accepted by regulators in all ICH regions. It has revolutionized regulatory review processes for regulators and industry.

15. ICH SUCCESSES MedDRA (Medical Dictionary for Regulatory Activities) 15 Highly specific, standardized medical terminology developed by ICH to facilitate sharing of regulatory information. It is used for registration, documentation and safety monitoring of medical products both before and after marketing authorization . It is used in 60 countries & available in II different languages. Prepared by ICH and owned by IFPMA .

16. ICH PRODUCTS (as of June 2022) 72 Guidelines on technical requirements on: • Quality - 25 Guidelines (14) • Safety – 16 Guidelines (12) • Efficacy – 22 Guidelines (21) • Multidisciplinary - 9 Guidelines (15) Electronic Standards for the Transfer of Regulatory Information (ESTRI) CTD/eCTD MedDRA ( standardised medical terminology) 16

17. ORGANISATION OF ICH 17

18. 1) Engagement in the ICH Process. -Past regular attendance in ICH meetings. -Past appointment of experts in WGs Application of ICH Guidelines. 2) Have implemented at least the following ICH Guidelines (“Tier 1”): -Q1: Stability Testing Guidelines. -Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. -E6: Good Clinical Practice Guideline. Membership in the Assembly— Eligibility Criteria for Regulators/Industry. 18

19. 19 BASIC FLOW OF DRUG TO MARKET

20. PRINCIPLE OF ICH GCP Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, monitoring, recording, reporting and analysis of trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. 20

21. HISTORICAL BACKGROUND 21

22. 22 More than 100 people died in 15 states in U.S. Tablet – Liquid Suspension was made by using a solvent named Diethylene glycol (Anti-freezing). As there were no established regulations to conduct preclinical or clinical trials, new suspension was not studied for safety and toxicity . Diethylene glycol was tested as toxic ingredient by the AMA laboratory and warning was made through newspaper and radio. Federal Food and Drug Act , 1938 was established in response to this tragedy making the premarketing safety data for novel drugs mandatory. SULFANILAMIDE DISASTER/TASTE OF RASPBERRIES/TASTE OF DEATH (1937)

23. 23 German Physicians conducted medical experiments on prisoners of war without their consent in during the time of Nazi rule. Most of the participants of these experiments died or were permanently crippled. The Nuremberg Code was established in 1948, stating that "The voluntary consent of the human participant is absolutely essential," It did not carry the force of law, but the Nuremberg Code was the first international document which advocated voluntary participation and informed consent. NUREMBERG CODE :1946

24. 24 Thalidomide was marketed in Germany in 1957 as an OTC for insomnia, cold and cough. Later it was used to relieve morning sickness in pregnant women. Mothers started using Thalidomide without prescription due to which in 1961, congenital anomalies were reported in newborns e.g. Phocomelia. Mortality was approx 2,000 and morbidity was more than 10,000 . In response to thalidomide disaster “Kefauver Harris Amendment” was released, which was an amendment to Federal Food Drug and Cosmetic Act 1938. This Act made it mandatory to the pharmaceutical company to state preapproval safety and efficacy of their drug and describing the possible side effects of the Drug. Kefauver Amendments 1962 – Thalidomide

25. 25 In 1961, public opinion around the world was shocked by the thalidomide scandal. Government authorities were then required to take action and make regulatory arrangements to oversee the testing of new medicines. In 1964 , the World M edical A ssociation (WMA) developed and indeed continues to review and adapt the declaration of Helsinki as a guide for performing research in human beings.   Followed Nuremberg code (1947). Regarded as cornerstone document of Human research ethics. DECLARATION OF HELSINKI -1964

26. 26 T he US Public Health Services conducted a Syphilis Study on 600 low income African-American individuals. During this study many people died of syphilis . Stopped in 1973 by the U.S. Department of Health, Education, and Welfare. 1974 National Research Act passed - National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research established. The commission produce Belmont Report (1979). Tuskegee Syphilis Study- 1932 to 1972

27. 27 3-BASIC PRINCIPLE OF BELMONT REPORT

28. 28 Reasons for such tragedies in clinical trials include • No scienti fic knowledge and lack of integrity of trials. • No approved Protocol. • Lack of ethical considerations. • Patient consent not received. • Lack of preclinical studies for safety and efficacy . • Participation in trials against subject’s willingness.

29. 13 PRINCIPLES OF ICH GCP E6 (R2) Ethics: Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements. Trial risk vs trial benefit: Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks. Trial participants: The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. 29

30. CONTINUE …. 30 Information on the Medicinal Product: The available non-clinical and clinical information on an Investigational Product should be adequate to support the proposed clinical trial. Good quality trials: Clinical trials should be scientifically sound, and described in a clear, detailed protocol. Compliance with the study protocol: A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.

31. CONTINUE… Medical Decisions: The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist. Trial Staff : Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective tasks. Informed Consent : Freely given informed consent should be obtained from every subject prior to clinical trial participation. 31

32. CONTINUE… Clinical Trial Data: All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification. Confidentiality: The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements. Good Manufacturing Practice: Investigational products should be manufactured, handled, and stored in accordance with applicable GMP. They should be used in accordance with the approved protocol. Quality Assurance: Systems with procedures that assure the quality of every aspect of the trial should be implemented. 32

33. REFERENCES https://www.ich.org/ https://admin.ich.org/sites/default/files/2023-11/OverviewOfICH_2023_1115_0.pdf 33

34. 34