Andrew Fisher, Lead Senior GCP Inspector at the UK Medicines and Healthcare products Regulatory Agency (MHRA), has published a blog comparing ICH E6(R3) (i.e., Revision 3) Good Clinical Practice (GCP) guideline with the currently approved and globally implemented E6(R2). Andrew, a member of the ICH Expert Working Group, provides a perspective on what is in this very long blog (it prints as 41 pages):
I have reviewed ICH E6(R2) and ICH E6(R3) and examined what changes have been by EWG which was a quite a time-consuming task! The following information is a personal summary of the changes that I have identified and I am not representing the EWG. A presentation is available from the EWG that provides their high-level summary of key changes made to the ICH GCP guideline. This blog is not intended to include every detailed change made or cover all text retained but should give you a flavour of the amendments made by the EWG. I anticipate that there could be publications that set out to discuss the changes in full detail during the consultation period, but this blog should start your understanding of what’s changed.
Personally, I’m in the process of reading E6(R3) and will follow up with this blog to better understand the changes as I consider what the impacts will be to organizations and people operating under the GCPs. But as I read both documents, I will keep in mind that E6(R3) is a draft and will change prior to finalization, so I won’t be recommending any changes to current practice at this time.
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