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. TO P I C
O R I G I N A N D P R I N C I P L E S O F I C H A N D
I C H - G C P G U I D E L I N E S
INSTITUTE OF
PHARMACEUTICAL
SCIENCES
Presented to –
Dr. Manjusha
choudhary
Presented by-
Arshi khanam
M.Pharm
(pharmacolog
y -2nd 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.

5. 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.

7. 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.

9. 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.

10. 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.

11. 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.

12. • 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.

13. ORGANIZATION OF ICH
• Medical
Dictionary
for
Regulatory
Activities
Terminology
(MedDRA)
• Q- quality
• S- safety
• E- efficacy
• M- medicines

14. 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.

15. • 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

16. ICH-GCP GUIDELINES (8 SECTIONS)
1. Glossary Common language for investigators/sponsors/ethics
committees
2. Principles of Good Clinical Practice 13 tenets of ICH GCP
3. Requirements for IRB(institutional review
board)/IEC(independent ethics committee)Roles responsibilities
and composition
4. Responsibilities of the investigator
5. Responsibilities of the sponsor
6. Requirements for clinical trial protocol and protocol amendments
7. Responsibility of the sponsor in the development of investigator’s
brochure.
8. Essential documents

17. 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).

18. ICH-GCP PRINCIPLES
1. 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.
2. The benefits for subjects and society should justify the risks.
3. The rights, safety, and well-being of subjects should prevail
over the interests of science and society.
4. The available clinical and nonclinical information on
investigational products should be adequate to support the
proposed clinical trial.

19. 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.

20. 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.

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 ICH
• 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

23. 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.

24. 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

25. THANK YOU