ICH (International Council for Harmonisation)

The international standard-setting body — a Swiss non-profit association of drug regulatory authorities and pharmaceutical-industry associations — that develops and maintains the harmonised technical guidelines, grouped into Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M) series, used to register medicines for human use across its member jurisdictions; ICH E6 Good Clinical Practice is one specific guideline it publishes, not a synonym for the organization itself.

ByCASRAI Editorial Board

· Last updated 17 Jul 2026

Worked examples

Is an instance

A sponsor running a single clinical development programme designs its nonclinical toxicology studies to ICH S-series guidelines and its Phase I-III trials to ICH E-series guidelines, then assembles the marketing application in the ICH M4 Common Technical Document format so the same core dossier supports submissions to FDA, EMA, and PMDA.

Is an instance

A regulatory affairs team tracks a draft ICH guideline from Step 2 (published for regulatory consultation) through Step 4 (adopted by the ICH Assembly) to Step 5, when it is implemented into that team's own national regulations.

Looks similar, but isn't

Not an instance

A national pharmacopoeia's country-specific excipient purity limit is not itself an ICH guideline — it may be informed by ICH Q-series quality standards, but ICH has no power to impose binding law; each member regulator implements, or declines to implement, a guideline through its own domestic process.

Not an instance

Using 'ICH' to mean investigator-site GCP compliance conflates the parent organization with one specific guideline (E6) it publishes among dozens across the Q, S, E, and M series — see the dedicated ICH GCP entry for that guideline specifically.

ICH is a Swiss non-profit association, headquartered in Geneva, that brings together drug regulatory authorities and the pharmaceutical industry to agree common scientific and technical guidelines for the quality, safety, and efficacy of medicines, so that a sponsor developing a new drug can run one core set of studies to support registration across multiple jurisdictions instead of duplicating them per country. It was founded in April 1990 in Brussels as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, initiated by regulators and industry associations from the European Union, Japan, and the United States. In 2015 its governance was reformed: it adopted its current name, the International Council for Harmonisation, and became a formal legal entity under Swiss law with a broader, more global membership beyond the three founding regions.

ICH’s overarching decision-making body is the ICH Assembly, made up of voting Members and non-voting Observers. The three Founding Regulatory Members are the European Commission, Japan’s Ministry of Health, Labour and Welfare (working with the Pharmaceuticals and Medical Devices Agency, PMDA), and the US Food and Drug Administration (FDA), alongside three Founding Industry Members: EFPIA, JPMA, and PhRMA. Health Canada and Swissmedic hold the status of Standing Regulatory Members. Since the 2015 reform, additional national and regional regulatory authorities have joined as Regulatory Members, and a larger group of regulators, regional harmonisation initiatives, and international bodies (including the World Health Organization) participate as Observers without a vote. A guideline begins in an Expert Working Group and advances through the Assembly’s five-step process, Step 1 (technical consensus) through Step 5 (domestic regulatory implementation by each member), before it takes effect in any single jurisdiction.

ICH organises its output into four coded guideline series: Q (Quality — manufacturing, stability, impurities, and pharmaceutical quality systems), S (Safety — nonclinical and preclinical toxicology and pharmacology), E (Efficacy — clinical trial design, conduct, safety reporting, and data analysis), and M (Multidisciplinary — cross-cutting topics such as the Common Technical Document submission format and MedDRA terminology). ICH E6 Good Clinical Practice is one guideline within the E series — itself one of ICH’s four series. ICH is the standard-setting organization that produces and maintains all of them; it is not a synonym for GCP specifically, and most of its guidelines govern preclinical, manufacturing, and submission-format questions that never touch a clinical trial site.

References

ICH, “History” and “Mission” (ich.org)
ICH Articles of Association, approved by the Assembly, 18 November 2020
ICH, “Members & Observers” (ich.org/page/members-observers)
ICH, “Formal ICH Procedure” — the Step 1–5 guideline development process (ich.org)

Use in your systems

JATS XML <role> element

xml

<role vocab="credit"
      vocab-identifier="https://casrai.org/dictionary/"
      vocab-term="ICH (International Council for Harmonisation)"
      vocab-term-identifier="https://casrai.org/dictionary/term/ich-international-council-for-harmonisation" />

Schema.org DefinedTerm (JSON-LD)

json

{
  "@context": "https://schema.org",
  "@type": "DefinedTerm",
  "@id": "https://casrai.org/dictionary/term/ich-international-council-for-harmonisation",
  "name": "ICH (International Council for Harmonisation)",
  "identifier": "https://casrai.org/dictionary/term/ich-international-council-for-harmonisation",
  "description": "The international standard-setting body — a Swiss non-profit association of drug regulatory authorities and pharmaceutical-industry associations — that develops and maintains the harmonised technical guidelines, grouped into Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M) series, used to register medicines for human use across its member jurisdictions; ICH E6 Good Clinical Practice is one specific guideline it publishes, not a synonym for the organization itself.",
  "inDefinedTermSet": "https://casrai.org/dictionary/domain/compliance-regulatory#set",
  "url": "https://casrai.org/dictionary/term/ich-international-council-for-harmonisation",
  "sameAs": [
    "International Council for Harmonisation",
    "International Conference on Harmonisation",
    "ICH guidelines",
    "International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use"
  ],
  "license": "https://creativecommons.org/licenses/by/4.0/",
  "publisher": {
    "@id": "https://casrai.org/#organization"
  },
  "dateModified": "2026-07-17T06:12:39",
  "inLanguage": "en"
}