Last Updated: October 2026

What are ICH guidelines? They are the harmonised technical standards for developing and registering medicines that the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) publishes. They fall into four series: Quality (Q), Safety (S), Efficacy (E) and Multidisciplinary (M). ICH guidelines are not law on their own, but regulators such as the FDA and EMA implement them, so following them is the practical route to a submission that is accepted across regions. The current Good Clinical Practice standard is ICH E6(R3).

Each country or region's regulatory authority (the FDA in the US, the EMA in Europe, Health Canada, and others) sets its own requirements for clinical research. Many trials recruit across borders and the resulting treatment is eventually distributed across them. By standardizing technical requirements, ICH aims to improve the efficiency and safety of drug development worldwide. Below, we walk through each of the four series, what the current guideline codes cover, and where the status of a guideline has recently changed.

In this guide:

• The four ICH guideline categories
• Quality guidelines (Q)
• Safety guidelines (S)
• Efficacy guidelines (E) and ICH E6(R3)
• Multidisciplinary guidelines (M)
• Are ICH guidelines mandatory?
• How to cite ICH guidelines
• ICH guidelines and Kivo
• Frequently asked questions

The four ICH guideline categories

ICH organizes its guidelines under four topic codes: Q for Quality, S for Safety, E for Efficacy and M for Multidisciplinary. Quality covers manufacturing and product quality, Safety covers nonclinical studies, Efficacy covers the design, conduct, safety and reporting of clinical trials, and Multidisciplinary covers topics that cut across the other three. Each guideline carries a code (such as E6) and, when revised, a revision tag (such as R3). The tables below list every current guideline and its status as published by ICH in October 2026.

Quality guidelines (Q)

Quality guidelines cover quality control throughout the drug development lifecycle, so that pharmaceutical products are consistently safe, effective and of high quality. Topics include stability studies, impurity testing, analytical validation, and flexible, risk-based approaches built on Good Manufacturing Practice (GMP). For a closer look at one of the most-used documents in the series, see our guide to ICH Q9 quality risk management.

The current Quality guidelines are outlined as follows:

Safety guidelines (S)

Safety guidelines are designed to uncover potential risks before a product reaches people, such as carcinogenicity, genotoxicity, reproductive toxicity and effects on the heart's electrical activity. They define which nonclinical studies support the move into human trials and later registration.

The current Safety guidelines are outlined as follows:

Efficacy guidelines (E) and ICH E6(R3)

Efficacy guidelines concern the design, conduct, safety and reporting of clinical trials. They also cover medicines derived from biotechnological processes and the use of pharmacogenetics and genomics to produce better-targeted medicines. This series includes the pharmacovigilance E2 family and the statistical principles in E9.

The current Efficacy guidelines are outlined as follows:

Note: there is no E13.

Good Clinical Practice: ICH E6(R3)

Among ICH's guidelines, Good Clinical Practice (GCP), code E6, is the fundamental standard for conducting clinical trials. It sets out the ethical and scientific standards for designing, conducting, recording and reporting trials involving human participants, protecting their rights, safety and well-being while keeping the resulting data credible.

ICH E6 is no longer in draft. According to ICH, the E6(R3) guideline was adopted in two stages: the Principles and Annex 1, a flexible, risk-based framework for interventional clinical trials, reached Step 4 on 6 January 2025, and Annex 2 was adopted on 3 June 2026. ICH is making Annex 2 available as a standalone document only through the end of 2026. For practical implementation detail, see our webinar on implementing ICH E6(R3). For the records side of GCP, see our guide to aligning eTMF with the CDISC TMF Reference Model.

Multidisciplinary guidelines (M)

Multidisciplinary guidelines are a catch-all for topics that do not fall into Quality, Safety or Efficacy, including medical terminology (MedDRA), the Common Technical Document (CTD), and electronic standards for the transfer of regulatory information (ESTRI). Several recent additions, including M11, M14 and M15, extend this series into protocol templates, real-world data and model-informed drug development.

The current Multidisciplinary guidelines are outlined as follows:

Of note: eCTD v4.0 has been rolling out over the past few years. For an in-depth look at the updates, read our article “Everything You Need to Know about eCTD 4.0”.

Are ICH guidelines mandatory?

ICH guidelines are not law by themselves, because ICH has no enforcement power. They become binding expectations when a regulatory authority implements them through its own regulation or guidance. ICH publishes an implementation status for each guideline, regulator by regulator, with dates; for example, its page for E1 shows the European Commission and the FDA among the regulators that have implemented it.

In practice, non-compliance with ICH guidelines can raise concerns during regulatory inspections and approvals, and adherence demonstrates a commitment to best practice and strengthens the credibility of clinical trial data. Teams should check how each guideline has been implemented by the regulators they file with, rather than assuming it applies the same way everywhere.

How to cite ICH guidelines

Proper citation acknowledges the source and keeps regulatory standards traceable. In academic or regulatory documents, the American Psychological Association (APA) style works well. The following format can be used:

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (Year of publication). Title of Guideline (ICH Guideline No.). Retrieved from URL

For example:

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (1996). Good Clinical Practice (ICH E6). Retrieved from https://database.ich.org/sites/default/files/E6_R1_Guideline.pdf

When citing a guideline that has been revised, cite the current revision (for E6, that means E6(R3), not the 1996 original used in the example) and the date of the Step 4 version you relied on.

ICH guidelines and Kivo

Kivo is a compliant document, content and process management platform for life sciences teams, and it is built to support ICH best practices in day-to-day work. Kivo includes over 450 pre-formatted ICH templates, including ICH M11 clinical protocol templates, authored natively in Microsoft Word. Kivo's eTMF is aligned to the TMF Reference Model, and the eCTD Viewer in Kivo RIM supports eCTD 4.0 for reviewing submissions. For help assembling submission-ready content, see our regulatory submission software.

If you have questions about how to conform to ICH standards, reach out to our team at any time.

Frequently asked questions

What are the four categories of ICH guidelines?

ICH groups its guidelines into Quality (Q), Safety (S), Efficacy (E) and Multidisciplinary (M). Quality covers manufacturing and product quality, Safety covers nonclinical testing, Efficacy covers clinical trial design, conduct and reporting, and Multidisciplinary covers cross-cutting topics such as MedDRA, the Common Technical Document and electronic standards.

What is the current version of ICH E6?

The current version is ICH E6(R3). According to ICH, the Principles and Annex 1 reached Step 4 on 6 January 2025, introducing a flexible, risk-based framework for interventional trials, and Annex 2 was adopted on 3 June 2026. It updates the earlier E6(R2) version that many teams worked to for years.

Are ICH guidelines legally binding?

Not on their own. ICH cannot enforce its guidelines, but regulators such as the FDA and the European Commission implement them through their own regulations and guidance, and ICH tracks each regulator's implementation status and date. Ignoring an implemented guideline can raise concerns during an inspection or application review.

Which ICH guidelines cover the Common Technical Document?

The Common Technical Document is covered by the M4 guideline, which organizes registration dossiers into quality, safety and efficacy parts. Its electronic version, the eCTD, is covered by M8, which includes eCTD v4.0. Both sit in the Multidisciplinary series rather than in Quality, Safety or Efficacy.