Question: There has been some discussion about the need to update the ICH GCP guideline (E6), which is now roughly 14 years old. Have there been any formal discussions on updating the guidance?
Answer: The Integrated Addendum of the ICH E6 Guideline is in the consultation period. The E6 Integrated Addendum has been developed to complement the harmonized ICH E6 Guideline which was finalized in May 1996. The intent of this Addendum is to modernize ICH E6 by supplementing it with additional recommendations which will facilitate broad and consistent international implementation of new methodologies. The Integrated Addendum consists of additional text which has been developed for several existing sections of the E6 Guideline and directly integrated into the parental Guideline.
The draft E6 Integrated Addendum can be downloaded on the ICH website (Draft Integrated Addendum). http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html