ICH-GCP.pptx

ICH GCP guidelines for mpharmacy 2nd sem 204T subject.
topic include the brief description regarding ICH GCP
THE GOOD CLINICAL PRACTICES AND
THE INTERNATIONAL CONFERENCE OF HORMONIZATION.
THAT INCLUDE the regulation of all pharmaceutical industries.

1. Topic Origin and principles of ICH and ICH-GCP guidelines Institute of pharmaceutical sciences Presented to – Dr. Manjusha choudhary Presented by- Arshi khanam M.Pharm (pharmacology -2 nd sem )

2. What is ICH? The International Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines. Since its inception in 1990, ICH has gradually evolved, to respond to increasingly global developments in the pharmaceutical sector and these ICH guidelines are applied by a growing number of regulatory authorities .

3. Continue .. ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use is an international cooperative that brings together the regulatory authorities of Europe, Japan, and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The ICH is a joint initiative, with regulators and industry as equal partners in scientific and technical discussions on the testing procedures that are required to ensure and assess the safety, quality, and efficacy of medicines.

4. Origin of ICH The birth of ICH took place at a meeting in April 1990, hosted by EFPIA( European Federation of Pharmaceutical Industries and Associations ) in Brussels. Representatives of the regulatory agencies and industry associations of Europe, Japan and the US met, primarily, to plan an International Conference but the meeting also discussed the wider implications and terms of reference of ICH. At the first ICH Steering Committee meeting of ICH the Terms of Reference were agreed and it was decided that the Topics selected for harmonization would be divided into Safety , Quality and Efficacy to reflect the three criteria which are the basis for approving and authorizing new medicinal products.

5. Why there is a need of harmonization? The realization that it was important to have an independent evaluation of medicinal products before they are allowed on the market was reached at different times in different regions. However in many cases the realization was driven by tragedies, such as that with thalidomide in Europe in the 1960s. For most countries, whether or not they had initiated product registration controls earlier, the 1960s and 1970s saw a rapid increase in laws, regulations and guidelines for reporting and evaluating the data on safety, quality and efficacy of new medicinal products. The industry, at the time, was becoming more international and seeking new global markets; however the divergence in technical requirements from country to country was such that industry found it necessary to duplicate many time-consuming and expensive test procedures, in order to market new products, internationally.

6. Continue … The urgent need to rationalize and harmonize regulation was impelled by concerns over rising costs of health care, escalation of the cost of R&D and the need to meet the public expectation that there should be a minimum of delay in making safe and efficacious new treatments available to patients in need.

7. Principles of ICH ICH's mission is to achieve greater harmonization worldwide to ensure that safe, effective and high quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards. Since its announcement of organizational changes in October 2015, ICH has grown as an organization and now includes 19 Members and 35 Observers . The resulting ICH association establishes an Assembly as the over-arching governing body with the aim of focusing global pharmaceutical regulatory harmonization work in one venue that allows pharmaceutical regulatory authorities and notably concerned industry organizations to be more actively involved in ICH’s harmonization work.

8. With ICH’s establishment as an international non-profit Association under Swiss law on October 23, 2015 , ICH’s mission has been embodied in its Articles of Association as follows: To make recommendations towards achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration and the maintenance of such registrations; To maintain a forum for a constructive dialogue on scientific issues between regulatory authorities and the pharmaceutical industry on the harmonization of the technical requirements for pharmaceutical products; To contribute to the protection of public health in the interest of patients from an international perspective; To monitor and update harmonized technical requirements leading to a greater mutual acceptance of research and development data.

9. To avoid divergent future requirements through harmonization of selected topics needed as a result of therapeutic advances and the development of new technologies for the production of medicinal products; To facilitate the adoption of new or improved technical research and development approaches which update or replace current practices; To encourage the adequate implementation and integration of common standards through the dissemination of, the communication of information about and coordination of training on, harmonized guidelines and their use; And to develop policy for the ICH Medical Dictionary for Regulatory Activities Terminology ( MedDRA ) whilst ensuring the scientific and technical maintenance, development and dissemination of MedDRA as a standardized dictionary which facilitates the sharing of regulatory information internationally for medicinal products used by humans.

10. Organization of ich Medical Dictionary for Regulatory Activities Terminology ( MedDRA ) Q- quality S- safety E- efficacy M- medicines

11. GOOD CLINICAL PRACTICE(GCP) The ICH Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting of trials that involve the participation of human subjects . The ICH GCP guideline was adopted by the Committee for Proprietary Medicinal Products in the EU in July 1996. The Japanese Ministry of Health adopted the guidelines in March 1997, and the USDA published the ICH GCP in the Federal Register on May 9, 1997.

12. To ensure the rights, safety and well being of the trial subjects are protected Ensure the credibility of clinical trial data  Provide a unified standard for the EU, Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in these regions . No acceptance of foreign clinical data Regional variation in registration guidelines Escalating costs Extended time for registration ICH region covers 85% of Pharm sales Need of GCP

13. Ich-gcp guidelines (8 sections) Glossary Common language for investigators/sponsors/ethics committees Principles of Good Clinical Practice 13 tenets of ICH GCP Requirements for IRB(institutional review board)/IEC(independent ethics committee)Roles responsibilities and composition Responsibilities of the investigator Responsibilities of the sponsor Requirements for clinical trial protocol and protocol amendments Responsibility of the sponsor in the development of investigator’s brochure. Essential documents

14. Ich-gcp principles In practice, these principles lead to a clinical trial staff€ that is qualified by education, experience, and training; informed-consent forms that are completed prior to study participation; protection of the confidentiality of the subject and of the information about the subject; investigational products that comply with the good manufacturing practices ; and assured quality of the study documentation and data (i.e., assured accuracy and integrity).

15. Ich-gcp principles Clinical trials should be conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GCP and the applicable regulatory requirements. The benefits for subjects and society should justify the risks. The rights, safety, and well-being of subjects should prevail over the interests of science and society. The available clinical and nonclinical information on investigational products should be adequate to support the proposed clinical trial.

16. 5. Clinical trials should be scientifically sound and described in a clear, detailed protocol. 6. A trial should be conducted in accordance with a protocol that has received prior institutional review board (IRB) or independent ethics committee (IEC) approval. 7.Medical care and decisions are made by a qualified physician or dentist. 8. Individuals conducting a trial should be qualified by education, training, and experience. 9. Freely given informed consent should be obtained from subjects prior to their participation in the clinical trial.

17. 10. All clinical trial information should be stored to allow for accurate reporting, interpretation, and verification. 11. Confidentiality of records that could identify subjects should be protected, protecting the subject’s privacy in accordance with applicable regulatory requirements. 12. Investigational products should be manufactured handled and stored in accordance with current good manufacturing practices. 13.Systems that assure the quality of every aspect of the trial should be implemented.

18. Role of gcp Good clinical practice ( gcp ) is an international ethical & scientific standard for conducting clinical trials that involve the participation of human subjects Compliance with this standard provides public assurance that the rights, safety & well-being of trial subjects are protected, which is consistent with the principles outlined in the declaration of helsinki GCP also ensures the credibility of clinical trial data.

19. Goals of ICH Safeguard public health Assure consumer protection standards F acilitate availability of safe and effective products Eliminate inconsistent standards internationally Facilitate mutual acceptance of data from clinical trials

20. Conclusion The purposes of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline are to protect the rights of human subjects participating in clinical trials and to ensure the scientific validity and credibility of the data collected in human clinical studies. The guiding principle in the guideline is that the rights, safety, and well-being of the trial subject are the most important considerations and should prevail over the interests of science and society. The guideline will have an important and beneficial impact on the clinical trials conducted in the three participating regions (the United States, Europe, and Japan) as well as many other regions throughout the world. In the years to come, it should fulfill its intended purpose of providing for a more economical use of human, animal, and material resources and the elimination of unnecessary delays in the global development and availability of new medicines, and at the same time maintaining safeguards on quality, safety, and efficacy and regulatory obligations to protect public health.

21. References www.ich.org database.ich.org file:///C:/ Users/dell/Desktop/ichgcp%20paper.pdf https://www.slideshare.net/AbhishekJoshi312/origin-and-principles-of-international-conference-on-harmonization-good-clinical-practices-ichgcp

22. Thank you