ICH GCP E6 (R2) Addendum

[a123456]

At last ICH GCP E6 R2 (version adopted date 09Nov2016) is published on ICH website
Despite the fact that ICH adopted GCP E6 R2 on 9th Nov 2016 and published a Press Release saying this on 17 Nov 2016, it was not until 30 Nov 2016 that they new draft appeared on the ICH website.
http://www.ich.org/fileadmin/Public_...R2__Step_4.pdf

[Shahnaz]

Many thanks for this

[ClinicalQuality]

I have a follow up question on this topic. ICH website indicates that each region is to determine the timeline for implementation of ICH GCP E6(R2).
Does anyone know how it will be implemented in the EU? For example, will Directive 2005/28EC be updated or will implementation coincide with implementation of the new CTR 536/2014 (which is not before 2018)? Does the EMA plan to publish further guidance before implementation?