ICH Guidelines

ICH Guidelines


After this session students will be able to

ICH establishment, its objectives and guidelines

What is ICH?

ICH is a joint initiative involving both regulators and
research-based industry representatives of the EU, Japan and the US in
scientific and technical discussions of the testing procedures required to
assess and ensure the safety, quality and efficacy of medicines.

What does ICH stand for?

The complete name of ICH is the “International Conference on
Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Human Use”.


The International Conference on Harmonisation of Technical
Requirements for the Registration of Pharmaceuticals for Human Use (ICH) was
established in 1990 as a joint regulatory/industry project to improve,
through harmonisation, the efficiency of the process for developing and
registering new medicinal products
in Europe, Japan and the United
in order to make these products available to patients with a
minimum of delay.

The six parties to ICH represent the regulatory
bodies and research-based industry in the three regions, Europe, Japan and the
USA, where the vast majority of new medicines are currently developed. 


The objective of such harmonisation is a more economical use
of human, animal and material resources, and the elimination of unnecessary
delay in the global development and availability of new medicines whilst
maintaining safeguards on quality, safety and efficacy, and regulatory
to protect public health.

Harmonising the technical content of the sections of the
reporting data where significant differences have been identified between
regulatory requirements across the three regions: Europe, Japan and the USA.


Target for the first phase of ICH activities was to
remove redundancy and duplication in the development and review process, such
that a single set of data could be generated to demonstrate the quality,
safety and efficacy
of a new medicinal product. 

Harmonised format has led to the creation of the ICH
Guideline M4
, The Common Technical Document (CTD).

The Electronic Common Technical Document (eCTD) was
developed subsequently by the M2 Expert Working Group.

Steering Committee structure and participation:

The existing Steering Committee structure continues to be
appropriate. In the interests of greater transparency, the Steering Committee,
however, welcomes the appropriate participation of other interested parties in
a flexible and ad hoc manner on topics which affect them.

Global co-operation 

The recent emphasis on global co-operation actions by ICH
acknowledges the important role of WHO in disseminating information and
providing input beyond the ICH regions.

ICH is comprised of Six Parties that are directly
involved, as well as three Observers and IFPMA. The Six Parties are the founder
members of ICH which represent the regulatory bodies and the research-based
industry in the European Union, Japan and the USA. These parties include the EU,

The Observers are WHO, EFTA, and Canada (represented by
Health Canada). This important group of non-voting members acts as a link
between the ICH and non-ICH countries and regions.

ICH is operated via the ICH Steering Committee, which is
supported by ICH Coordinators and the ICH Secretariat.

ICH Parties

European Commission – European Union (EU)

The European Commission represents the 27 members of the
The Commission works through harmonisation of legislation and technical
and procedures, to achieve a single market in
pharmaceuticals to allow free movement of products throughout the EU.

The European Medicines Agency (EMEA) has been
established by the Commission and is situated in London. Technical and
scientific support for ICH activities is provided by the Committee for
Medicinal Products for Human Use (CHMP) of the EMEA.

European Federation of Pharmaceutical Industries and
Associations (EFPIA)

EFPIA, is situated in Brussels and has, as its
members, 29 national pharmaceutical industry associations and 45
leading pharmaceutical companies
involved in the research, development and
manufacturing of medicinal products in Europe for human use. Much of the
Federation’s work is concerned with the activities of the European Commission
and the EMEA.

A wide network of experts and country coordinators has been
established, through Member Associations, to ensure that EFPIA’s views within
ICH are representative of the European industry.

Ministry of Health, Labour and Welfare, Japan (MHLW)

The Ministry of Health, Labour and Welfare has
responsibilities for approval and administration of drugs, medical devices and
cosmetics in Japan.

Technical and scientific support for ICH activities are
provided by the Pharmaceuticals and Medical Devices Agency (PMDA) (which was
established in April 2004 as a new administrative agency for scientific
review for drug approval), and by the National Institute of Health Sciences
(NIHS) and other experts from academia.

Japan Pharmaceutical Manufacturers Association (JPMA)

JPMA represents 75 members (including 20 foreign affiliates)
and 14 committees. Membership includes all the major research-based
pharmaceutical manufacturers in Japan.

US Food and Drug Administration (FDA)

The US Food and Drug Administration has a wide range of
responsibilities for drugs, biologicals, medical devices, cosmetics and
radiological products. The largest of the world’s drug regulatory agencies FDA
is responsible for the approval of all drug products used in the USA.

The FDA consists of administrative, scientific and
regulatory staff organised under the Office of the Commissioner and has several
Centers with responsibility for the various products which are regulated.
Technical advice and experts for ICH work are drawn from the Center for Drug
Evaluation and Research (CDER) and the Center for Biologics Evaluation and
Research (CBER).

Pharmaceutical Research and Manufacturers of America

The Pharmaceutical Research and Manufacturers of America –
PhRMA – represents the research-based industry in the USA. The Association has 67
in membership which are involved in the discovery, development
and manufacture of prescription medicines. There are also 24 research
which conduct biological research related to the development of
drugs and vaccines.

PhRMA, which was previously known as the US
Pharmaceutical Manufacturers Association (PMA)
, coordinates its technical
input to ICH through its Scientific and Regulatory Section. Special committees
have been set up, of experts from PhRMA companies, to deal with ICH topics.

ICH Observers

Since ICH was initiated, in 1990, there have been observers
to act as a link with non-ICH countries and regions. The ICH Observers are:

The World Health Organisation (WHO)

The European Free Trade Association (EFTA), currently
represented at ICH by Swissmedic Switzerland

Canada, represented at ICH by Health Canada


The International Federation of Pharmaceutical Manufacturers
& Associations is a non-profit, non-governmental Organization (NGO) representing
national industry associations and companies from both developed and developing

ICH Steering Committee

is administered by the ICH Steering Committee which is supported by the ICH Secretariat.

Steering Committee, working with the ICH
Terms of Reference
, determines the policies and procedures for ICH, selects
topics for harmonisation and monitors the progress of harmonisation

Steering Committee meets at least twice a year with the location rotating
between the three regions.

the beginning, each of the six co-sponsors has had two seats on the ICH
Steering Committee (SC). 

ICH Observers, WHO, Health Canada, and the European Free Trade Association
(EFTA) nominate non-voting participants to attend the ICH Steering Committee

The ICH Secretariat

Secretariat operates from the IFPMA offices, in
Geneva, and is primarily concerned with preparations for, and documentation of,
meetings of the Steering Committee.

the time of ICH Conferences, the Secretariat is responsible for the technical
documentation and for liaison with the speakers for the Conference.

ICH Guidelines

ICH Topics are divided into four major categories and ICH Topic Codes are
assigned according to these categories.





, i.e., those relating to chemical and pharmaceutical Quality
Assurance (Stability Testing, Impurity Testing, etc.)

, i.e., those relating to in vitro and in vivo pre-clinical
studies (Carcinogenicity Testing, Genotoxicity Testing, etc.)

, i.e., those relating to clinical studies in human subject
(Dose Response Studies, Good Clinical Practices, etc.)

, i.e., cross-cutting Topics which do not fit uniquely into one of
the above categories (MedDRA, ESTRI, M3, CTD, M5)


Q1A(R2) : Stability Testing of New Drug
Substances and Products 

Q1B        : Stability
Testing: Photostability Testing of New Drug Substances and Products

 Q1C       :
Stability Testing for New Dosage Forms 

Q1D       :
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances
and Products 

Q1E        : Evaluation
of Stability Data 

Q1F        : Stability
Data Package for Registration Applications in Climatic Zones III and IV 

Analytical Validation

Q2(R1) : New title: Validation of Analytical Procedures:
Text and Methodology  

Q3A(R2) : Impurities in New Drug Substances

Q3B(R2) : Impurities in New Drug Products

Q3C(R3) : Impurities: Guideline for Residual


Q4          :  Pharmacopoeias

Q4A       : Pharmacopoeial

Quality of Biotechnological Products

Q5A(R1) : Viral Safety Evaluation of
Biotechnology Products Derived from Cell Lines of Human or Animal Origin


Q6A : Specifications : Test Procedures and
Acceptance Criteria for New Drug Substances and New Drug Products: Chemical
Substances (including Decision Trees)

Q6B : Specifications : Test Procedures and
Acceptance Criteria for Biotechnological/Biological Products

Good Manufacturing Practice

Q7A :     Good
Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Q8(R1) :               Pharmaceutical Development

Q9                          :
Quality Risk Management

Q10                        :
Pharmaceutical Quality

Safety Efficacy guidelines

Efficacy Topics

E3: Structure and Content of Clinical Study Reports

E4: Dose-Response Information to Support Drug Registration

E6: Good Clinical Practice : Consolidated Guideline

E8: General Considerations for Clinical Trials

E9: Statistical Principles for Clinical Trials

E10: Choice of Control Group and Related Issues in Clinical

Multidisciplinary Guidelines

M1- MedDRA     : Medical

M2- ESTRI            :
Electronic Standards for the Transfer of Regulatory Information

M3- (R2)              :
Nonclinical Safety Studies for the Conduct of Human Clinical Trials and
Marketing Authorization for Pharmaceuticals

M4- CTD               :
The Common Technical Document

M5                         :
Data Elements and Standards for Drug Dictionaries

ICH Secretariat,
c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20, Switzerland
Tel: +41 (22) 338 32 06, Telefax: +41 (22) 338 32 30


The complete name of ICH is the “International Conference on
Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Human Use”.

The objective of ICH is to increase international
harmonization of technical requirements to ensure that safe, effective, and
high quality medicines are developed and registered in the most efficient and
cost effective manner

ICH provides guidelines on 
quality, safety, efficacy and multi-disciplinary aspects for registration
of new drugs


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