19 February 2015

The ICH M8 electronic Common Technical Document Implementation Guide (eCTD IG) reached Step 2b of the ICH Process in February 2015 and now enters the consultation period (Step 3).

The ICH M8 EWG was formed in November 2010 to assume responsibility for the continued development of the next major version of the eCTD. The M8 EWG has developed the draft of the ICH eCTD v4.0 IG which is now being made available as DRAFT v2.0 along with the draft ICH Code Lists.

The draft IG package can be downloaded on the ICH eCTD v4.0 Step 2 page on the ICH ESTRI website.

You are invited to provide comments on the draft IG 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.