1. ICH-GCP Avinash Kondawar M. Pharm Lead CRA
ICON Clinical Research India Pvt Ltd.,
Bangalore

2. ICH International Conference on Harmonization
Joint initiative involving regulators and industry as equal partners:
European Union
Japan
United States
Scientific and technical discussions of the testing procedures which are required to ensure and assess the safety, quality and efficacy of medicines

3. ICH Began in April 1990 in Brussels
ICH guidelines are usually more stringent than FDA rules and regulations.

4. ICH meetings ICH 1- Brussels, Belgium - Nov 1991
ICH 2- Orlando. U.S.A – Oct, 1993
ICH 3- Yokohama, Japan – Nov,1995
ICH 4- Brussels – July,1997
ICH 5- San Diego, U.S.A – Nov,2000
ICH is comprised of representatives from six parties that represent the regulatory
bodies and research-based industry in the European Union, Japan and the USA.
ICH is comprised of representatives from six parties that represent the regulatory bodies and research-based industry in the European Union, Japan and the USA.

5. ICH Sponsors and Regions
EMEA: The European Commission
EFPIA: European Federation of Pharmaceutical
Industries Association
FDA: CDER & CBER
PhRMA Pharmaceutical Research and
Manufactures of America
JMHW: Japanese Ministry of Health and
Welfare
JPMA: Japanese Pharmaceutical Manufactures
Association

6. ICH Topics
Quality – those relating to chemical and pharmaceutical Quality.
Safety – those relating to in vitro and in vivo pre-chemical studies.
Efficacy – those relating to clinical studies in human subjects.
Multidisciplinary – cross cutting topics which do not fit uniquely into one of the above categories.

7. ICH Efficacy E6= Good Clinical Practice
E2A= Clinical Safety Data Management
E8= General Considerations for Clinical Trials
Good Clinical Practice:
Describes the responsibilities and expectation of all participants in the conduct of clinical trials

8. Aims of ICH Unify registration requirements for new products
Reduce medicinal product development costs: more economical use of animal, human and material resources.
Accelerate medicinal product licensing times: avoid repeat testing in different regions.
Increases patent protection times through reducing delay in licensing times.

9. ICH GCP
Good Clinical Practices (GCP) is an international ethical & scientific quality standard for designing, conducting, recording & reporting trials that involve the participation of human subjects.
Compliance with this standard provides public assurance that rights, safety & 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.

10. ICH GCP- Objective
To provide a unified standard for the EU, Japan & the US to facilitate the mutual acceptance of clinical data by regulatory authorities in these jurisdictions
To identify and then to reduce differences in technical requirements for drug development among regulatory agencies.

11. Principles of ICH GCP
Clinical Trials should be conducted in accordance with the ethical principles consistent with GCP and applicable regulatory requirements
Before a trial is initiated, foreseeable risks & inconveniences should be weighed against anticipated benefit for the trial subject & society.
A trial should be initiated and continued only if the anticipated benefits justify the risks.

12. Principles of ICH GCP
The rights, safety, and well being of the trial subjects are the most important considerations & should prevail over interests of science and society.
The available non-clinical & clinical information on an investigational product should be adequate to support the proposed clinical trial.

13. Principles of ICH GCP
Clinical trials should be scientifically sound, & described in a clear, detailed protocol; which has received prior IRB/IEC approval
The medical care and medical decisions for subjects should be the responsibility of a qualified physician
Each individual involved in conducting a trial should be qualified by education, training & experience to perform his respective task(s)

14. Principles of ICH GCP
Freely given informed consent should be obtained from every subject prior to clinical trial participation
All clinical information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification
The confidentiality of records that could identify patients should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

15. Principles of ICH GCP
Investigational products should be manufactured, handled and stored in accordance with applicable GMP and used in accordance with the protocol
Systems with procedures that assure the quality of every aspect of the trial should be implemented

16. Thank You