ICH (International Council for Harmonisation)

Who writes the rulebook the regulators share?

In one sentence

The ICH is the association where medicines regulators and industry write the technical guidelines that regulators then adopt as their own.

A non-profit association under Swiss law since 2015: an Assembly of regulators and industry associations, a Management Committee, a permanent Secretariat. Its E2 guidelines set the clocks of pharmacovigilance, 7 and 15 days for an expedited case among them, and MedDRA is its dictionary.

Where it sits

The members25 Members, regulators and industry associations, and 41 Observers (June 2026)
Governing bodyThe Assembly adopts the guidelines; a Management Committee runs the work
AssociationICH: founded in 1990, a non-profit under Swiss law since 23 October 2015
For safetyThe E2 guidelines and MedDRAThe clocks, the case format and the dictionary of pharmacovigilance

Think of it like this

Think of a building code that the city and the architects write together. Every city still signs its own permits, but how thick a wall must be is agreed once, for everyone.

Key insights

Regulators and industry, one tableA guideline is not a lawIts E2 series sets the clocksMedDRA is its dictionary

The International Council for Harmonisation (ICH) calls itself unique in bringing regulatory authorities and the pharmaceutical industry together to harmonise the technical requirements for the safety, efficacy and quality of medicines. Born in Brussels in 1990 with three regulators and three industry associations, it had 25 Members and 41 Observers by June 2026.

A guideline passes five steps: consensus in an expert working group, confirmation by the Assembly, consultation in each region, adoption at Step 4. Only Step 5, implementation by each regulator in its own framework, binds anyone. The Assembly decides by consensus; when that fails, only the regulatory members vote.

E2A gave clinical trials the 7-day and 15-day clocks in 1994; E2D gave the market its 15 days in 2003 and was revised in 2025. E2F made the yearly development report, E2C(R2) the periodic benefit-risk report, E2E the pharmacovigilance plan, E2B(R3) the electronic case. Chapter 2 shows which one shapes your document.

MedDRA, the Medical Dictionary for Regulatory Activities, is the terminology the ICH first developed in the late 1990s for coding what happened to a patient. An ICH steering committee directs it, a maintenance organisation releases it every March and September in 25 languages beyond English and Japanese, and regulators subscribe for free.

Jump to: 1 Three moments 2 Your dossier, their guideline 3 What the network adds to the law 4 Test yourself

Chapter 1

Which three moments made the ICH what it is?

Pick a year. Each turned a meeting into a standard.

1990Three regions, one table2015From conference to council2025The case report rewritten

Three regions, one table

The plan took shape in Paris in 1989, at a World Health Organization conference of drug regulators. The authorities then approached the international industry federation, and in April 1990 the regulators and industry associations of Europe, Japan and the United States met in Brussels, hosted by the European Federation of Pharmaceutical Industries and Associations (EFPIA). The International Conference on Harmonisation was born.

The first Steering Committee split the work into Safety, Quality and Efficacy. The safety reporting guideline came early: E2A, with its 7-day and 15-day clocks for trials, reached Step 4 on 27 October 1994. The first decade also produced MedDRA and the Common Technical Document.

What it left behind: the habit of a topic, an expert working group and a guideline in five steps.

From conference to council

For 25 years the ICH was a conference of six founders: the European Commission, the United States Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare on one side; the European, Japanese and American industry associations on the other. On 23 October 2015 the inaugural Assembly made it an international association, a legal entity under Swiss law, and renamed it the International Council for Harmonisation.

The Articles of Association adopted that day made the Assembly the governing body, with a Management Committee for operations and a steering committee for MedDRA. Membership opened: in November 2016 the Assembly decided that every Member pays a fee from 2018, and by June 2026 the list held 25 Members and 41 Observers.

What it left behind: a council with a budget, a permanent Secretariat and seats for regulators beyond the three founding regions.

The case report rewritten

The post-approval case has had one global definition since E2D in 2003: a serious, unexpected reaction reaches the regulator within 15 calendar days of first receipt. Its format moved separately. E2B, first issued in 1997, was rebuilt as E2B(R3) together with the standards bodies, the first ICH topic made that way, on a standard of the International Organization for Standardization (ISO) and Health Level Seven (HL7) published in November 2011.

In June 2019 the Assembly endorsed a revision of E2D, and on 15 September 2025 E2D(R1) reached Step 4: definitions, standards and good case management practices for post-approval individual case safety reports.

What it left behind: thirty-one years after E2A, the single case still has one definition and one clock, and now one file format.

Chapter 2

Your dossier, their guideline

A safety document is due on your product. Two questions decide which ICH guideline shapes it: is the medicine approved yet, and is it one case or a period? Pick a cell.

Before approvalAfter approvalA single caseCase, in trialsCase, on the marketA periodic reportReport, in trialsReport, on the market

Or it is not a report at all: the safety plan in the application or the words a case is coded in

In a clinical trial, E2A sets the clock. A fatal or life-threatening unexpected adverse drug reaction (ADR) is notified no later than 7 calendar days after the sponsor first knows the case qualifies, with a complete report within 8 more days. Other serious, unexpected reactions have 15 calendar days. ICH E2A, Step 4, 27 October 1994, section III.B

Once the medicine is approved, E2D takes over: a serious and unexpected reaction is reported as soon as possible and in no case later than 15 calendar days after the holder first receives the information. E2D(R1), Step 4 on 15 September 2025, revises it. ICH E2D, section 4.3; ICH E2D(R1), Step 4, 15 September 2025

A medicine still in development gets a Development Safety Update Report (DSUR), submitted annually. E2F wrote it as one common standard in place of the United States and European Union annual reports. ICH E2F, Step 4, 17 August 2010, section 1

On the market, the periodic report is the Periodic Benefit-Risk Evaluation Report (PBRER). Each product has one international birth date, its first approval anywhere in the world, and data lock points counted from it, so that different regulators can review the same report. ICH E2C(R2), Step 4, 17 December 2012, section 2.8.1

Before any report there is the plan. E2E describes a Safety Specification and a Pharmacovigilance Plan that might be submitted with the application: the important identified risks, the important potential risks and the missing information. ICH E2E, Step 4, 18 November 2004, section 1.1

Whatever the document, the reaction is coded in MedDRA, the terminology the ICH first developed in the late 1990s. Its maintenance organisation releases it every March and September, free to every regulator. ICH, MedDRA

The International Council for Harmonisation is unique in bringing together regulatory authorities and the pharmaceutical industry to harmonise scientific and technical requirements for the safety, efficacy and quality of medicines.
ICH, Vision & Mission, shortened: the value proposition

The guidelines, the same page adds, are embedded in the regulatory frameworks of many jurisdictions. Embedded is the word: the ICH writes them, the regulators make them law.

Chapter 3

What does the network add to the law?

Only a regulator’s own rules bind a company. Five places where the ICH wrote the text those rules copy.

	The law	The ICH
The 15-day clock	Each region sets its own deadline for a serious case	One definition of serious and unexpected: 7 and 15 days in trials, 15 days after approval
The case file	Each regulator could ask for its own format	E2B(R3): one electronic case, built with the international standards bodies
The words in the case	Nothing	MedDRA, under an ICH steering committee, two releases a year, free for regulators
The periodic report	A regional report on a regional calendar	One benefit-risk report with one international birth date; one development report a year in place of two regional ones
When it binds	Only once a regulator implements it: Step 5	Adoption at Step 4 by the Assembly, by consensus; when consensus fails, only regulators vote

Show the references

The clock: ICH E2A, section III.B; ICH E2D, section 4.3.
The case file: ICH, E2B(R3) Individual Case Safety Report specification page.
The words: ICH, MedDRA page.
The periodic report: ICH E2C(R2), section 2.8.1; ICH E2F, section 1.
When it binds: ICH, Formal ICH Procedure; ICH, Overview of ICH, June 2026.

The ICH writes no law. It writes the text that the laws copy.

The facts, in one place

What it is	A global non-profit association of medicines regulators and industry associations that harmonises technical requirements for the safety, efficacy and quality of medicines.
Since	April 1990, a meeting in Brussels hosted by the European industry federation; an international association under Swiss law since 23 October 2015.
Who decides	The Assembly, which adopts the guidelines by consensus or, failing that, by a vote of the regulatory members; a Management Committee for operations; a steering committee for MedDRA.
Members	25 in June 2026: 19 regulators and six industry associations; 41 Observers, the World Health Organization among them, who attend but do not vote.
Money	Annual membership fees from every Member since 2018, paying for a permanent Secretariat and two meetings a year; MedDRA pays for itself through subscriptions.
How a guideline is made	Five steps: consensus in an expert working group, confirmation by the Assembly, consultation in each region, adoption, implementation.
For safety	E2A to E2F, the E2B(R3) case format, E2E’s pharmacovigilance plan and MedDRA.

Don’t confuse it with: the regulators’ coalition

ICH

The guideline writer

Is: an association of regulators and industry, with a permanent Secretariat and a membership fee
Decides: technical guidelines, adopted by the Assembly and implemented by each regulator
Example: E2D(R1), the post-approval case definitions, Step 4 in September 2025

The coalition

International Coalition of Medicines Regulatory Authorities (ICMRA)

Is: a voluntary, executive-level coalition of regulatory authorities, with no industry at the table
Decides: strategic priorities and joint positions, not technical guidelines
Example: its pharmacovigilance sub-groups on big data and on vaccines

Chapter 4

Test yourself

Myth or Truth? Pick an answer to see the explanation.

“An ICH guideline binds a company the day it reaches Step 4.”

MythTruth

MythYou got it.Not quite.

Step 4 is adoption by the Assembly: the text is recommended to the regulators. Step 5 is implementation, when each regulator writes it into its own framework, and only that binds a company.

“When the Assembly cannot reach consensus, only the regulatory members vote.”