ICH Q10 and its 5 linked instruments
How to read this page
- First column: ICH Q10. The others are every document linked to it.
- Scroll sideways if there are more columns than fit.
- It does not compare content. It does not say which is stricter. Read the official texts for that.
| ICH Q10 | ICH Q9(R1) | Chapter 1 (2013) | Chapter 1 revision | Annex 15 | EMA AI reflection paper | |
|---|---|---|---|---|---|---|
| Authority | ICH | ICH | European Commission | European Commission | European Commission | EMA |
| Legal weight | Guidance & Q&A | Guidance & Q&A | GMP guide & annexes | GMP guide & annexes | GMP guide & annexes | Guidance & Q&A |
| Status | Final | Final | In force | Draft | In force | Final |
| Last verified | Not yet | Not yet | Not yet | Not yet | Not yet | Not yet |
| Summary | ICH model for an effective quality management system for the pharmaceutical industry. | The international guideline on quality risk management. It is the basis for scaling validation effort to risk in Annex 11, Annex 22 and computer software assurance, and the 2023 revision addresses subjectivity, formality and risk-based decision-making. | The current EU GMP chapter on the pharmaceutical quality system. | Draft revision of the EU GMP quality system chapter, recommended jointly by the GMP/GDP Inspectors Working Group and the PIC/S Committee to reflect ICH Q9(R1). Draft only. | The EU GMP annex on qualification and validation. | EMA's current thinking on AI and machine learning for human and veterinary medicines, covering principles that apply at any stage of a medicine's lifecycle, from drug discovery to after authorisation. |
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| Source | Official text Source: ICH. | Official text Source: ICH. | Official text Source: European Commission. Licensed under CC BY 4.0. | Official text Source: European Commission. Licensed under CC BY 4.0. | Official text Source: European Commission. Licensed under CC BY 4.0. | Official text Source: EMA. |
These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.