ICH GCP E6 (R2) Addendum

[Margit Zehrer]

Hi Dorothea. My understanding is the following: step 4 means the guideline is content final and agreed within the ICH organization. Step 5 is the official adoption by the member countries - without content changes. But the content is transferred e.g. to the FDA Guideline Format and get's - most important - a coming into effect date (specific for the country). Hopefully this helps.

[a123456]

ICH E6 (R2) Good Clinical Practice adopted by CPMP (Europe) Dec2016, effective 14June2017
Several of the links on the EMA website do not work correctly and some of the revision numbers may be muddled. . However it is clear that the EMA has adopted ICH GCP E6 (R2) and that it comes into "operation from 14 June 2017.
http://www.ema.europa.eu/ema/index.j...01ac0580032ec4