ICH Guidelines

ICH Guidelines


After this session students will be able to

       Explain 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 States, 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 obligations 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, EFPIA, MHLW, JPMA, FDA and PhRMA

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 EU. The Commission works through harmonisation of legislation and technical requirements 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 (PhRMA)

The Pharmaceutical Research and Manufacturers of America - PhRMA - represents the research-based industry in the USA. The Association has 67 companies in membership which are involved in the discovery, development and manufacture of prescription medicines. There are also 24 research affiliates 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 countries.

ICH Steering Committee

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

       The 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 initiatives.

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

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

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

The ICH Secretariat

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

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

ICH Guidelines

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





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

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

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

"Multidisciplinary" Topics, 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 Solvents


Q4          :  Pharmacopoeias

Q4A       : Pharmacopoeial Harmonisation

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 System

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 Trials

Multidisciplinary Guidelines

M1- MedDRA     : Medical Terminology

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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