We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].
Public Consultation: ICH E6(R3) [GCP] Principles, Annex 1 and Annex 2
ICH – The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials.
Public consultation dates:
Health Canada, Canada – Deadline for comments by 20 October 2023
Earlier consultation dates:
HSA, Singapore – Deadline for comments by 30 September 2023
EC, Europe – Deadline for comments by 26 September 2023
Swissmedic, Switzerland – Deadline for comments by 26 September 2023
MHLW/PMDA, Japan – Deadline for comments by 9 September 2023
FDA, United States – Deadline for comments by 5 September 2023
ANVISA, Brazil – Deadline for comments by 31 August 2023
MHRA, UK – Deadline for comments by 31 August 2023
NMPA, China – Deadline for comments by 31 August 2023
TFDA, Chinese Taipei – Deadline for comments by 31 August 2023
Center for Informed Consent Integrity 