ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation
ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation
Date first published: 6 January 2025
The ICH E6(R3) Guideline reached Step 4 of the ICH process on 6 January 2025. The finalised E6(R3) guideline will be a document setting out the overarching principles and objectives, as well as Appendix 1 and Appendix 2.
The ICH E6 (R3) Step 4 presentation is available online here. If you need more details, please watch the presentation here.
The link to download the draft version of the ICH E6 (R3): Step 4.
References:
- M Khair ElZarrad (2023) ‘An Important Global Good Clinical Practice Standards draft soon becomes available for public input of the field stakeholders’ [Online]. Available from: https://lnkd.in/etxNzD_e (Accessed: 23 May 2023).
- Fisher, A. and Wakelin-Smith, J. (2023) ‘ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation’ [Online]. Available from: https://mhrainspectorate.blog.gov.uk/2023/05/02/ich-e6r3-good-clinical-practice-guidance-step-2-public-consultation/ (Accessed: 18 May 2023)
- Bregnhøj, L., Sweeney, F., the ICH EWG (2020) ‘Introduction to ICH E6(R3) and stakeholder engagement plan’ [Online]. Available from: https://www.ema.europa.eu/en/documents/presentation/presentation-12-introduction-ich-e6r3-stakeholder-engagement-plan-l-bregnhoj-f-sweeney_en.pdf (Accessed: 18 May 2023).
