ICH E6(R3) GCP and its 3 linked instruments

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ICH E6(R3) GCPFDA BA/BE data integrityEMA AI reflection paperEMA notice: CS in trials
AuthorityICHFDAEMAEMA
Legal weightGuidance & Q&AGuidance & Q&AGuidance & Q&AGuidance & Q&A
StatusFinalDraftFinalFinal
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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.

Lifecycle
  • 8 Sep 2025 Published by FDA as final guidance
  • 3 Apr 2024 Draft guidance issued
  • 19 Jul 2023 Draft released for public consultation
  • 31 Dec 2023 Public consultation closed
  • 9 Sep 2024 Final version adopted by CHMP
  • 30 Sep 2024 Final version published
  • 7 Apr 2020 First published
  • 29 Oct 2026 Revision 1: administrative update of references
SourceOfficial 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.