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)

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. History
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?
 Ist conf. in 1990 in Brussels
3 regions participated
 Representatives from
Industry
Academia
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. The ICH Story
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
1. Glossary
Common language for
investigators/sponsors/ethics
committees
2.Principles of Good Clinical Practice
13 tenets of ICH GCP
3.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
7.Responsibility of the sponsor in the
development of investigator’s
brochure.
8.Essential documents

17. Principles of ICH 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. Principles of ICH GCP
The available nonclinical and clinical information on an
investigational product should be adequate to support the proposed
clinical trial.
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. Principles of ICH 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. Principles of ICH 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