ICH E6(R3) GCP and its 3 linked instruments
How to read this page
- First column: ICH E6(R3) GCP. 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 E6(R3) GCP | FDA BA/BE data integrity | EMA AI reflection paper | EMA notice: CS in trials | |
|---|---|---|---|---|
| Authority | ICH | FDA | EMA | EMA |
| Legal weight | Guidance & Q&A | Guidance & Q&A | Guidance & Q&A | Guidance & Q&A |
| Status | Final | Draft | Final | Final |
| Last verified | Not yet | Not yet | Not yet | Not yet |
| Summary | Revised ICH guideline on good clinical practice. FDA says it adds flexible, risk-based approaches and embraces innovations in trial design, conduct and technology. | Draft FDA guidance for applicants and testing sites on achieving and maintaining data integrity in the clinical and bioanalytical parts of bioavailability and bioequivalence studies. | 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. | EMA notice to clinical trial sponsors on validating and qualifying computerised systems, such as electronic case report forms and patient reported outcome tools. |
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| Source | Official text Source: ICH. | Official text Source: FDA. Public domain. | Official text Source: EMA. | 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.