Glossary · ICH guidelines
International Council for Harmonisation (ICH)
Also known as: ICH, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, International Conference on Harmonisation
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international association of medicines regulators and pharmaceutical industry bodies that develops harmonized guidelines on the quality, safety and efficacy of medicines. Its guidelines become binding expectations once regional regulators such as EMA and FDA implement them.
- ICH
- Pharma
In one sentence
ICH brings medicines regulators and industry together to write harmonized guidelines on quality (Q), safety (S), efficacy (E) and multidisciplinary topics (M).
Example
A drug developer plans one development program and one dossier for the EU, the USA and Japan, relying on ICH Q8(R2) for development, ICH E6(R3) for its trials and the CTD format (ICH M4) for the submissions.
How it applies
- History: Founded in 1990 by regulators and industry from the EU, Japan and the USA as the International Conference on Harmonisation. Since 2015 it has been a Swiss association under its current name, with a broader membership of regulators and industry bodies.
- Guideline families: Q for quality, S for safety (nonclinical), E for efficacy (clinical) and M for multidisciplinary topics such as the Common Technical Document.
- Five-step process: A guideline moves from consensus building through a draft for public consultation and regional consultation to adoption by the ICH Assembly (Step 4) and implementation by each regulator (Step 5). Only Step 4 guidelines are final; drafts at Step 2 or 3 are not requirements.
- Implementation: EMA publishes ICH guidelines as scientific guidelines, and ICH Q7 is Part II of EU GMP; FDA publishes them as guidance for industry. Legal force comes from the regional implementation, not from ICH itself.
- Technical documentation: Cite the ICH guideline with its revision code, such as Q9(R1) or E6(R3), because revisions change the expectations. Check which revision the relevant regulator has implemented.
| Guideline | Topic | Status used in this glossary |
|---|---|---|
| ICH Q7 | GMP for active pharmaceutical ingredients | Adopted 2000 |
| ICH Q8(R2) | Pharmaceutical development, quality by design | Revision 2 adopted 2009 |
| ICH Q9(R1) | Quality risk management | Revision 1 adopted January 2023 |
| ICH Q10 | Pharmaceutical quality system | Adopted 2008 |
| ICH Q12 | Product lifecycle management, post-approval changes | Adopted 2019 |
| ICH Q2(R2) and Q14 | Validation and development of analytical procedures | Adopted November 2023 |
| ICH E6(R3) | Good clinical practice | Adopted January 6, 2025; EMA effective July 23, 2025 |
| ICH M4 | Common Technical Document (CTD) | Format for marketing authorization dossiers, modules 1 to 5 |
ICH guidelines vs. ISO standards
ICH guidelines are written by and for medicines regulators and the pharmaceutical industry and are implemented as regulatory guidance. ISO and IEC standards such as ISO 13485 are consensus standards; in the EU, harmonized versions give a presumption of conformity under the medical device rules. ICH guidelines have no such mechanism, and medical devices are outside ICH's scope.