Origin and principles of international conference on harmonization- Good clinical practices (ICH-GCP))

The ppt gives a basic information about ICH-GCP, how it originated , what led to the formation of ICH-GCP guidelines and what are the principles of the guidelines.

1. Origin and Principles of International Conference on Harmonization- Good Clinical Practice (ICH-GCP) Presented by: Abhishek .S. Joshi First Year M. Pharm (Sem 2) (Pharmacology) SSR College of Pharmacy, Silvassa

2. What is ICH? ICH is a joint initiative involving both the regulators and the industry as equal partners in the scientific and technical discussions of the testing procedures which are required to ensure and assess the safety, quality and efficacy of medicines.

3. How did it evolve? The need to harmonize Public disasters, serious fraud and abuse of human rights. Trials of War criminals-Nuremberg code 1949 Thalidomide- Declaration of Helsinki 1964 Belmont report 1978( Ethical Principles and guidelines for the protection of human subjects of research)- Tuskegee syphilis study

4. H ist o r y 1962 US FDA IND Guidelines 1964 Declaration of Helsinki 1968 Committee on Safety of Medicines, uk 1978 GCP, US FDA 1991 GCP, Europe 1996 ICH GCP 1997 ICH GCP Guideline

5. When did it begin?  I st conf. in 1990 in Brussels 3 regions participated  Representatives from Industry Ac a dem i a Ministry of health

6. ICH parties 6 parties EU EFPIA European federation of pharmaceutical industries’ associations MHLW Ministry of health, Labor and welfare, Japan JPMA Japan Pharmaceuticals manufacturers Association US FDA PhRMA Observers : WHO, TPP(canada) International federation of Pharmaceutical manufacturer’s association

7. Key objective  To discuss and define the minimum standards for the development and registration of investigational products

8. The result? Many guidelines made Most important- ICH GCP guidelines Evolved in several steps Consolidated guideline ICH E6 Sept 1997

9. ICH Guidelines: examples Efficacy: clinical trials etc Safety:  pharmacovigilance, adverse drug reaction reporting  Quality: raw materials, impurities, residual solvents etc Multidisciplinary: common technical document, electronic submission, coding systems

10. Th e I CH St o r y Who: Regulatory authorities and research- based industry of the EU, US and Japan; WHO, EFTA and Canada observers Why: Reduce unnecessary duplication and thereby contribute to the efficiency of drug development and registration for new pharmaceuticals How: Through the development of science- based, international guidelines and standards

11. What is GCP? A standard for the design, conduct, performance, monitoring ,auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible, accurate and that the rights, integrity and confidentiality of trial subjects are protected.

12. Why is it needed?  To ensure the rights, safety and well being of the trial subjects are protected  Ensure the credibility of clinical trial data

13. The ICH GCP guideline  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 . ?The need No acceptance of foreign clinical data Regional variation in reg guidelines Escalating costs Extended time for registration ICH region covers 85% of Pharm. sales

14. ICH GCP guideline 8 sections

15. ICH GCP guideline Glossary Common language for investigators/sponsors/ethics committees Principles of Good Clinical Practice 13 tenets of ICH GCP Requirements for IRB/IEC Roles responsibilities and composition

16. ICH GCP guideline 4.Responsibilities of the investigator 5.Responsibilities of the sponsor 6.Requirements for clinical trial protocol and protocol amendments Responsibility of the sponsor in the development of investigator’s brochure. Essential documents

17. Pr in c iple s o f I CH GCP 1. 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 requirement(s) 2. 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. 3. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

18. Pr in c iple s o f I CH GCP 4. The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial. 5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol. 6. 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. 7. 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.

19. Pr in c iple s o f I CH GCP 8. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s) 9. Freely given informed consent should be obtained from every subject prior to clinical trial participation. 10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

20. Pr in c iple s o f I CH GCP 11. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). 12. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol. 13. Systems with procedures that assure the quality of every aspect of the trial should be implemented.

21. 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.

22. GOALS OF INTERNATIONAL HARMONIZATION OF REGULATORY REQUIREMENTS SAFEGUARD PUBLIC HEALTH ASSURE CONSUMER PROTECTION STANDARDS FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS