ICH Introduction

(Training Module# 001)

International Conference on
Harmonization – an Introduction

ICH

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 ICH Introduction
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ICH

 INTERNATIONAL CONFERENCE ON
HARMONISATION OF TECHNICAL
REQUIREMENTS FOR REGISTRATION OF
PHARMACEUTICALS FOR HUMAN USE
(ICH).

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WHAT ?

 An agreement between the European Union

(EU), Japan and the United States (US) Joint
initiative between government regulators and
industry manufacturers.

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WHY?

 to harmonize regulatory requirements for the

testing, application and approval process of
pharmaceutical medications.
 Regulatory Bodies:
FDA : Food and Drug Administration– USA
MHLW : Ministry of Health & Labour Welfare,
Japan
EMA/ EMEA: European Medicines Agency
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Some Regulatory Bodies (Country-wise):

USFDA(USA), MHRA(UK), TGA(Australia),
CDSCO (India), HEALTH CANADA(CANADA),
EMEA (European Union), SFDA (China),
MHLW/ PMDA(Japan), KFDA(Korea),

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Historical Overview

 During 1980’s EC member nations began

bilateral discussions with both Japan and the
United States
 Planning began to materialize at the World
Health Organization’s (WHO) Conference on
Drug Regulatory Authorities in Paris in 1989
 ICH was created in April 1990 at a meeting
in Brussels

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NEED FOR HARMONISATION

 RAPID INCREASE IN LAWS, REGULATIONS AND

GUIDELINES FOR TESTING SAFETY, QUALITY
AND EFFICACY OF NEW PRODUCTS
 DIFFERENT TECHNICAL REQUIREMENTS BY
REGULATORY AGENCIES , ALTHOUGH
FUNDAMENTAL GUIDING PRINCIPLES SAME
 INDUSTRY BECOMING GLOBAL, DUPLICATION
OF TIME CONSUMING AND EXPENSIVE TESTING

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PROGRESS TOWARDS
INTERNATIONAL HARMONISATION

 GOALS :
 DECREASE COUNTRY-TO-COUNTRY
DIFFERENCES IN GUIDELINES
 DECREASE DIFFERENCES BETWEEN
REGULATORY AUTHORITIES

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TARGET

 STREAMLINE DRUG DEVELOPMENT AND

REGULATORY PROCESS INCREASE
EFFICIENCY AND ENFORCEMENT OF
GMP, GLP AND GCP GUIDELIENS
PROGRESS TOWARDS INTERNATIONAL
HARMONISATION

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ICH FOUNDER MEMBERS

 ICH FOUNDER MEMBERS EUROPEAN UNION :

EUROPEAN COMMISSION (EU) ,
 EFPIA (EUROPEAN FEDERATION OF
PHARMACEUTICAL; INDUSTRIES,
ASSOCIATIONS)
 JAPAN : MINISTERY OF HEALTH AND WELFARE
 JPMA ( JAPAN PHARMACEUTICAL
MANUFACTURERS ASSOCIATION)
 USA : FDA
 PhRMA (PHARMACEUTICAL RESEARCH AND
MANUFACTURERS OF AMERICA

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Initiation of ICH

 Formation of steering committee

 Agreement on terms of references
 Expert working groups
 Eleven topics
 Four categories

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 Eleven possible topics to address divided

into four main categories
 QUALITY
 SAFETY
 EFFICACY
 MULTIDISCIPLINARY

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ICH Guidelines Topics

ICH Guidelines

MULTI
QUALITY SAFETY EFFICACY
DISCIPLINARY
(Q) (S) (E)
(M)

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Brief Listing of ICH guidelines

 Stability Guidelines for Quality Control

(Q1A - Q1F)
 Analytical Validation -Q2
 Impurity Guidelines -Q3A - Q3D
 Pharmacopoeias -Q4A - Q4B
 Quality of Biotechnological Products -Q5A - Q5E
 Specifications -Q6A- Q6B
 Good Manufacturing Practice -Q7

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Brief Listing of ICH guidelines

 Pharmaceutical Development -Q8

 Quality Risk Management -Q9
 Pharmaceutical Quality System -Q10
 Development and Manufacture of Drug
Substances -Q11
 Pharmaceutical product lifecycle
management -Q12

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Quality Guidelines

 Harmonisation achievements in the

Quality area:
conducting of stability studies,
defining relevant thresholds for
impurities testing and,
a more flexible approach to
pharmaceutical quality based on
Good Manufacturing Practice
(GMP) and risk management.

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Safety Guidelines

 ICH has produced a comprehensive

set of safety Guidelines to uncover
potential risks like
carcinogenicity,
genotoxicity
and reprotoxicity.

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Multidisciplinary Guidelines

 Those are the cross-cutting topics

which do not fit uniquely into one
of the Quality, Safety and Efficacy
categories.
 It includes the ICH medical
terminology (MedDRA),
 the Common Technical Document
(CTD)
 and the development of Electronic
Standards for the Transfer of
18 Regulatory Information (ESTRI).
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ICH Steering Committee

 Monitors and Facilitates EWGs

 An EWG has 6 Topic Leaders - one from
each ICH party Expert Working Groups
 Determines the policies and procedures for
ICH
 Selects topics for harmonization
 Monitors the progress of harmonization
initiatives
 Has two members for each of the six co-
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Expert Working Groups

 The Steering Committee assigns an EWG to

each of the technical topics selected
 The groups are comprised of industry
specialists on the topics discussed from each of
the six members
 Do not have a fixed membership

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Current Status of Harmonization

(over 50 harmonized guidelines)

 Efficacy - 12 topic headings/14 guidelines
 Safety - 7 topic headings/14 guidelines
 Quality - 7 topic headings/19 guidelines
 Medical Dictionary - MedDRA Electronic
Standards - ESTRI,

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What are the Products of ICH?

 Over 50 harmonized guidelines aimed at

eliminating duplication in the development
and registration process, so that a single set
of studies can be generated to demonstrate
the quality, safety and efficacy of a new
medicinal product.
 Include CTD- describes the common format
for the preparation of a well-structured CTD
for applications that will be submitted to
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What are the Products of ICH?

 Facilitate international electronic

communication through Electronic Standards
for the Transfer of Regulatory Information (
ESTRI ) that will meet the requirements of
the pharmaceutical companies and
regulatory authorities.
 Electronic Common Technical Document (e
CTD) MedDRA Terminology

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