Die folgenden Informationen sind nur auf Englisch verfügbar:
As announced by M Khair ElZarrad (PhD, MPH, Director, Office of Medical Policy - Center for Drug Evaluation and Research at FDA), on May 22, 2023, ICH-E6(R3): An Important Global Good Clinical Practice Standards draft soon becomes available for public input of the field stakeholders.
Since 2016, the year of finalization of the ICH E6(R2) Good Clinical Practice (GCP) guideline, the clinical research field faced advances in technology that came along with rising complexity of trials, and global challenges. Reasonably, the International Council for Harmonisation (ICH) Expert Working Group for ICH E6(R3) was created to address the growing gaps between the existing regulations and real-world processes, such as growing variety of study types and data sources, as well as quality concerns.
Bregnhøj, L., Sweeney, F., d the ICH EWG (2020) summarised the scope of the ongoing work on the fundamental E6(R3) amendment, with its overarching principles laid in the Annex 1, the Glossary, and in the 3 Appendices, that will replace the current E6(R2), as listed below:
The MHRA (a full member of ICH since May 2022) experts are welcoming feedback of the UK stakeholders that will be collected through the Agency’s website (Fisher, A. and Wakelin-Smith, J., 2023). Clinical Research specialists from other countries will be able to provide their comments on the ICH website.
The Step 4 (Adoption of Technical Document: Principles and Annex 1) is planned in August 2023 (ICH E6(R3) EWG Work Plan, 2022).
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).