International Conference on Harmonization

(ICH)

Submitted by
AVISHEK CHAKROBORTY
M.Pharm( Pharmacology) 1st year
Roll NO. 22158
En. No. 141361
Guided By: Dr. RAJESH KUMAR SHARMA

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 CONTENT
Introduction
History
ICH- E6 R(2) Guidelines
Good Clinical Practice
ICH- GCP Guidelines
Role of GCP
Goals of International Harmonization of Regulatory
Requirements

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International Conference on Harmonization
(ICH)
• The International Conference on Harmonization of
Technical Requirements for Registration of
Pharmaceuticals for Human Use, commonly referred
to as ICH, is an organization that brings together
regulatory authorities and the pharmaceutical
industry to develop and establish international
guidelines for the development, registration, and
post-approval of pharmaceutical products.
• Primary participants: USA, Europe, and Japan.

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 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

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 ICH- E6 R(2) Guidelines
• The ICH E6 guidelines, also known as ICH E6
(R2), refer to the "Guideline for Good Clinical
Practice E6(R2)" developed by the International
Conference on Harmonization (ICH).
• This guideline provides a framework for the
conduct of clinical trials and the ethical principles
that should be followed to ensure the safety,
integrity, and reliability of trial data. The "R2" in
the title indicates that this is the second revision of
the original E6 guideline.

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 Good Clinical Practice(GCP)
• Good Clinical Practice (GCP) is an international
ethical and scientific quality standard for the
design, conduct, recording, and reporting of
clinical trials involving human subjects.
• GCP guidelines are designed to ensure the
protection of participants' rights, safety, and well-
being, as well as to provide credible and reliable
data on the safety and efficacy of investigational
products.

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 ICH-GCP Guidelines
• ICH-GCP stands for the "International
Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals
for Human Use - Good Clinical Practice."
• It's a set of internationally recognized guidelines
that outline the standards and principles for
conducting clinical trials involving human
subjects.
• These guidelines are intended to ensure the ethical
conduct, safety, and reliability of clinical trials and
the data generated from them.
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 ICH-GCP Guidelines
• Clinical Trial Design and Protocol Development:
Guidelines for developing a scientifically sound and
ethically justified clinical trial protocol.
• Informed Consent: Guidelines for obtaining voluntary
and informed consent from trial participants, ensuring
they are fully informed about the trial's purpose,
procedures, potential risks, and benefits.
• Safety Monitoring and Reporting: Guidelines for
ensuring the safety of trial participants through
systematic monitoring and reporting of adverse events
and serious adverse events.
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 ICH-GCP Guidelines
• Data Collection and Management: Guidelines for
collecting accurate and reliable data through proper
documentation and record-keeping procedures.
• Quality Assurance and Quality Control: Guidelines for
implementing quality assurance and control measures
to ensure the integrity of trial data and adherence to
GCP principles.
• Investigator Responsibilities: Guidelines outlining the
responsibilities of investigators conducting clinical
trials, including their role in ensuring participant
safety and data accuracy.

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 ICH-GCP Guidelines
• Ethics Committees/Institutional Review Boards (IRBs):
Guidelines for the role and responsibilities of ethics
committees or IRBs in reviewing and approving clinical
trial protocols.
• Monitoring and Auditing: Guidelines for monitoring and
auditing clinical trials to verify compliance with protocol
requirements and GCP standards.
• Documentation and Record Keeping: Guidelines for
maintaining essential documents related to the trial,
including the protocol, informed consent forms, and other
trial-related documents.
• Clinical Trial Reports: Guidelines for preparing accurate
and comprehensive clinical trial reports for regulatory
submission and publication.
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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

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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.

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THANK YOU

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Schedule Y
• "Schedule Y" refers to the schedule within the Drugs and Cosmetics Rules
of India that provides guidelines and regulations for the conduct of
clinical trials and new drug approvals in India.
• These rules are enforced by the Central Drugs Standard Control Organization
(CDSCO), which is the regulatory authority for pharmaceuticals and medical
devices in India
• It is concerned with two things
• Clinical trials
• New drugs

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Schedule Y — Guidelines for conduct of clinical
trials
• Approval Process: Procedures for obtaining approval
from the Drug Controller General of India (DCGI) for
conducting clinical trials.
• Informed Consent: Guidelines for obtaining informed
consent from trial participants and the necessary
documentation.
• Ethics Committees: Requirements for the composition,
functions, and responsibilities of ethics committees
reviewing and approving clinical trial protocols.

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Schedule Y — Guidelines for conduct
of clinical trials
• Investigator Responsibilities: Duties and responsibilities of
investigators conducting clinical trials, including
adherence to Good Clinical Practice (GCP) guidelines.
• Monitoring and Reporting: Guidelines for monitoring
the progress of clinical trials and reporting adverse events.
• Clinical Trial Materials: Regulations related to the
import, manufacture, and distribution of investigational
new drugs for clinical trials.

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Schedule Y — New Drug Approvals
Schedule Y also outlines the requirements for obtaining approval for
new drugs in India, including
• Investigational New Drug (IND): Requirements for obtaining
permission to import, manufacture, or distribute an investigational new
drug for clinical trials.
• Clinical Data Requirements: Guidelines for providing clinical data,
including safety and efficacy data, for the approval of new drugs.

• Multicentric Clinical Trials: Procedures for conducting multicentric

clinical trials involving multiple sites across India.
• Post-Approval Requirements: Regulations for post-approval studies
and monitoring of new drugs after they are granted marketing
authorization.

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