International Council for Harmonisation (ICH), the basics

This post is an attempt to provide basic information on the International Council for Harmonisation (ICH) and its functions.

Click on the ‘+’ sign next to each heading to access the information under each heading.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global platform for harmonisation. It brings together the regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH Guidelines.

Its mission is to achieve greater harmonisation worldwide to ensure that safe, effective and high quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards.

The purpose of ICH is the promotion of public health through international harmonisation that contributes to:

  • Reduction of unnecessary animal testing without compromising safety and effectiveness accomplished through technical guidelines implemented by the regulatory
  • Prevention of unnecessary duplication of clinical trials and post-market clinical evaluations
  • Development and manufacturing of new medicines
  • Registration and supervision of new medicines
  • Post-authorisation safety reporting and pharmacovigilance
1980sHarmonisation of regulatory requirements was pioneered by the EC, Europe, in the 1980s, as the EC, Europe moved towards the development of a single market for pharmaceuticals. The success achieved in Europe demonstrated that harmonisation was feasible. At the same time there were discussions between Europe, Japan and the US on possibilities for harmonisation.
1989It was at the WHO Conference of Drug Regulatory Authorities (ICDRA), in Paris, in 1989, that specific plans for action began to materialise. Soon afterwards, the authorities approached International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) to discuss a joint regulatory-industry initiative on international harmonisation, and ICH was conceived.
April 1990The birth of the ICH took place at a meeting in April 1990, hosted by EFPIA in Brussels. Representatives of the regulatory agencies and industry associations of Europe, Japan and the US met, primarily, to plan an International Conference but the meeting also discussed the wider implications and terms of reference of ICH
At the first ICH Steering Committee meeting of ICH the Terms of Reference were agreed and it was decided that the Topics selected for harmonisation would be divided into Safety, Quality and Efficacy to reflect the three criteria which are the basis for approving and authorising new medicinal products.
23 October 2015The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural Assembly meetings on this date, establishing ICH as an international association, a legal entity under Swiss law.

This step built upon a 25-year track record of successful delivery of harmonised guidelines for global pharmaceutical development as well as their regulation, and a longer standing recognition of the need to harmonise.

ICH works on the following four guideline types:

Click on any of the links above to show all of the guidelines under that particular guideline type.

The harmonisation activities undertaken by ICH falls into one of the following four categories:

  • Formal ICH procedure
  • Q&A procedure
  • Revision procedure
  • Maintenance procedure

Brief information on each of the above categories is provided in the table below. Further information is available upon clicking the links provided in the first column of the table.

Harmonisation activityWhat the activity
Is a concept
paper required?
Is a business
plan required?
Formal ICH
New topic for
harmonisation of ICH
YesYesThis is essentially a five step procedure
Q&A procedureClarification needed
for an existing ICH Guideline
YesMay be required
in certain cases
The additional guidance is usually developed in the form of Questions and Answers “Q&As”.

The Q&A Procedure is driven by questions/issues raised by stakeholders, which serve as the basis for the development of model questions for which standard answers are developed.
Revision procedureContent of an existing ICH Guideline out of date or no longer valid


New information to be added to an existing ICH Guideline
YesNoThe revision procedure is followed either in cases where the scientific/technical content of an existing ICH Guideline is no longer up-to-date or valid,


in cases where there is new information to be added with no amendments to the existing ICH Guideline necessary. In the case of the latter, the new information can be added in the form of an Addendum or an Annex to the Guideline in question.
Maintenance procedureNew information to be added to an existing ICH Guideline?Concept Paper required for maintenance of Guidelines. No Concept Paper required for M2 Recommendations maintenanceNoThe maintenance procedure is currently applicable for changes to the Q3C, Q3D and M7, Q4B (Annexes) and S5 (Annexes 1 & 2) Guidelines and M2 Recommendations. In each case the procedure is used:
· when there is new information to be added or · the scientific/technical content is out-of-date or no longer valid

Brief information the five step Formal ICH Procedure is provided in the tabled below. This procedure is followed for the harmonisation of all new ICH topics.

You can read more about each of the 5 steps here.

Step NoAbout the StepFurther information
Step 1Consensus building – Technical DocumentThe Expert Working Group (EWG) works to prepare a consensus draft of the Technical Document, based on the objectives set out in the Concept Paper.
Step 22a. ICH Parties consensus on Technical Document /
2b. Draft Guideline adoption by Regulators
Step 2a is reached when the Assembly agrees, based on the report of the EWG, that there is sufficient scientific consensus on the technical issues for the Technical Document to proceed to the next stage of regulatory consultation.

Step 2b is reached when the Regulatory Members endorse the draft Guideline.
Step 3Regulatory consultation and DiscussionStep 3 occurs in three distinct stages: regulatory consultation, discussion and finalisation of the Step 3 Expert Draft Guideline.
Step 4Adoption of an ICH Harmonised GuidelineStep 4 is reached when the Assembly agrees that there is sufficient consensus on the draft Guideline.

The Step 4 Final Document is adopted by the ICH Regulatory Members of the ICH Assembly as an ICH Harmonised Guideline at Step 4 of the ICH process.
Step 5ImplementationThis step is carried out according to the same national/regional procedures that apply to other regional regulatory guidelines and requirements, in the ICH regions.

ICH Guidelines are implemented in accordance with the applicable national/local/regional rules, with the stage of implementation of all ICH Guidelines also being dependent on when a Member or Observer has joined ICH.

Further information is available here on the implementation of ICH guidelines and you can also search for the Status of Implementation of ICH Guidelines by ICH Members

You can find ongoing public consultations here.

Yes there is . You can view it here.

How ICH guidelines are named and/or numbered can be understood with a couple of examples as shown below:

1) Q4B Annex 1(R1) Residue on Ignition/Sulphated Ash General Chapter

Q = Quality

4B – This is the number of the guideline

Annex 1 (R1) – RI means that the Annex 1 has undergone its first revision. This means that R2, R3 etc would imply imply second and third revisions respectively.

The ICH Harmonised Annex was finalised under Step 4 in November 2007. This annex is the result of the Q4B process for Residue on Ignition/Sulphated Ash General Chapter. This annex was revised (R1) on 27 September 2010 to include the Interchangeability Statement from Health Canada, Canada.

Residue on Ignition/Sulphated Ash General Chapter – This is the name of the guideline

2) E6(R3) Good Clinical Practice (GCP)

E – Efficacy

6 – This is the guideline number.

R3 – This means that this is the third revision of the guideline.

The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials. Additional information may also be found in ICH Reflection Paper on “GCP Renovation” on the ICH Reflection Paper page. When complete, E6(R3) will be composed of an overarching principles and objectives document, Annex 1 and Annex 2.

Good Clinical Practice – This is the name of the guideline

If there are any ongoing consultations, you can find them here. Once you click on the relevant guideline, you will see the public consultation dates by country and a deadline for comments will be given for each country concerned. An example of how this is presented is given below:

Public consultation dates

ANVISA, Brazil – Deadline for comments by 31 August 2023

EC, Europe – Deadline for comments by 26 September 2023

Yes, there is a way to find out.

First locate the guideline from this page. Then click the link on the relevant guideline. If the guideline has been implemented, an implementation status will be provided by country. This information will be presented as follows:

Implementation status

ANVISA, Brazil – Implemented; Date: 1 October 2024; Reference: RESOLUÇÃO RDC Nº 658/2022

COFEPRIS, Mexico – Not yet implemented;

EC, Europe – Implemented; Date: 1 June 2009; Reference: CHMP/ICH/167068/2004

Yes, on the ICH website, there is a section on Training where you can get access to a training library as well as some high resolution ICH Training videos shared on a YouTube channel.

The values of ICH include any/all of the following:

  • Demonstrates a commitment to high standards for public health
  • Allows participation in international harmonisation
  • Gives a say on the technical and policy environment of the future
  • Provides input to ICH governance
  • Provides an international forum for communication and the building of relationships

Source: ICH

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