30 July 2015

The Integrated Addendum of the ICH E6 Guideline reached Step 2b of the ICH Process in June 2015 and now enters the consultation period (Step 3). The E6 Integrated Addendum has been developed to complement the harmonised ICH E6 Guideline which was finalised in May 1996. The intent of this Addendum is to modernise 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 Efficacy Guideline page on the ICH website (Draft Integrated Addendum). You are invited to provide comments on the draft E6 Integrated Addendum by e-mailing the ICH Secretariat. More details under the Open Consultation page.

Note that stakeholders from EU, USA, Japan, Canada and Switzerland are encouraged to submit their comments to their respective Regulatory Authorities.