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International Conference On
Harmonisation –Good Clinical
Practice (ICH-GCP) Guidelines
SUBMITTED BY
SYAMA. J.S
1ST M.PHARM
DPS Cheruvandoor
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ICH
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ICH MISSION
ICH's origin in 1990, the ICH process has step by step evolved.
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As the second tenner the exploitation of ICH Guidelines continued, but
with more care given to the following need to:
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460 BC- Oath of Hippocrates
1930- US Food Drugs and Cosmetic Act
I st conference of ICH in 1990 in Brussels
1947 -Nuremberg code
3 regions participated
1948-Declaration of Human Rights Representatives from- Industry
1962- US FDA IND Guidelines Academia
Ministry of health
1964- Declaration of Helsinki
1968- Committee on Safety of Medicines, UK
1978 - GCP, US FDA
1982 -International Guidelines for Biomedical Research Involving Human Subjects
1990- ICH
1991- GCP, Europe
1996 - ICH GCP
1997 - ICH GCP Guideline 6
PURPOSE OF ICH
•To provide a form for regulatory authorities and the pharmaceutical
industry to discuss the requirements for drug development.
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ICH PARTIES
Key players in ICH process are the six parties drawn from regulatory bodies and
pharmaceutical companies in Europe, Japan and the United states.
•European commission(EU)
•European federation of pharmaceutical industries and association(EFPIA).
•Japanese ministry of health, labour and welfare(MHLW).
•Japan pharmaceutical manufactures association(JPMA).
•United states of food and drug administration(US FDA).
•Pharmaceutical research and manufactures of America (PhRMA)
OBSERVERS
•WHO ,TPP (Canada)
•International federation of Pharmaceutical manufacturer’s association
•EFTA(European Free Trade Association) 8
WORK PRODUCTS
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ICH GUIDE LINES
Quality
Safety
Efficacy
Multidisciplinary
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QUALITY
Mainly relates to
Chemical & pharmaceutical QA.(Raw materials, Impurities,
Residual Solvents)
Stability & Specifications .
Quality guidelines
Q1:Stability-photostability
Q2:Analytical validation
Q3:Impurities
Q4:Biotechnological Quality
Q5:Specifications
Q7:GMP for active Pharma ingredients
Q8:Pharmaceutical development 12
S8:Immunotoxicity
EFFICACY
Consistent with the principles that have their origin in the Declaration Of
Helsinki, and the clinical trial data are credible.
To ensure the rights, safety and well being of the trial subjects are protected
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ICH GCP The History & Development
1536 Ambroise Paré , Wound healing
( Perhaps the first ever clinical trial was James Lin’s demonstration that
citrus fruits cure scurvy .He compared the effects of various different
acidic substances, ranging from vinegar to cider, on groups of afflicted
sailors, and found that the group who were given oranges and lemons had
largely recovered from scurvy after 6 days.)
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ICH – GCP : Evolution
1980s - EC
Pioneered harmonization of regulatory requirements
Develop single market for medicinal products
Demonstrated feasibility of harmonization
1989, Paris - WHO Conference of Drug Regulatory Authorities
IFPMA – discuss joint regulatory-industry initiative
ICH conceived
Apr, 1990, Brussels – EFPIA
Birth of ICH
ICH Steering Committee established
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1990/91 Guidelines on GCP in Europe
1996 ICH GCP conference
1997 All clinical trials in Europe must comply to the ICH /GCP
guidelines
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OBJECTIVES OF ICH GCP
Protect the patient
To provide a unified standard for the European Union (EU), Japan & United States
to facilitate mutual acceptance of clinical data by the authorities in these
jurisdictions
Facilitate the mutual acceptance of clinical data across ICH GCP regions
The guidance was developed with consideration of current GCP of the European
Union , Japan, and the United States as well as those of Australia, Canada , the
Nordic countries and the WHO
The guidance should followed when generating clinical trial data that are
intended to be submitted to regulatory authorities.
The principle established in this guidance may also be applied to other clinical
investigations that may have an impact on the safety and well being of human
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subjects
ICH – GCP COVERS
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(Institutional Review Board/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.
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2. Risk Benefit
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.
5.Scientific protocol
Clinical trial should be scientifically sound and described in a clear, detailed
protocol
6.Independent Review
A trial should be conducted in compliance with the protocol that has received
prior Institutional Review Board(IRB)/Independent Ethics
Committee(IEC)approval/ favourable opinion.
9.Informed consent
Freely given informed consent should be obtained from every subject
prior to clinical trial participation
10.Accurate Data
All clinical trial information should be recorded, handled and stored in
a way that allows its accurate reporting, interpretation and
verification.
11.Confidentiality
The confidentiality of records that could identify subjects should be
protected, respecting the privacy and confidentiality rules in
accordance with the applicable regulatory requirements. 29
12.IMP to GMP
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 .
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Indian GCP guidelines
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CONCLUSION
The events that led up to the culmination of the ICH-GCP guidelines brought
forth public awareness that there was a need to control and regulate clinical
trials dealing with drugs and human subjects.
The violation of human rights played a large role and that is why the
Declaration of Helsinki and The Nuremberg Code remain as the framework of
the present guidelines.
The ICH-GCP guidelines are therefore considered the ‘bible’ of clinical trials,
and have become a global law which safeguards humanity as we know it
today. 32
REFERENCE
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