You are invited to provide comments on any of the draft (Step 2b) Guidelines (see list below for current consultations) by e-mailing the ICH Secretariat.

You are also very welcome to send questions and comments concerning the implementation of the ICH Guidelines (see list below for current IWG). Indeed, the ICH Steering Committee establishes Implementation Working Groups to assist in Guideline implementation, as needed. Such additional implementation guidance/advise is usually developed in the form of Questions and Answers ("Q&As").

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

Draft Step 2b Guideline currently undergoing regulatory consultation:

  • M8 eCTD IG

    Description :

    In February 2015, the Draft eCTD v.4.0 Implementation Guide v.2.0 and related documents were released under Step 2b of the ICH Process and are made available for regulatory consultation until 22 May 2015.

    Step 2b :

    February 2015

    Deadline for comments :

    22 May 2015

    Comment to :
    eCTD IG :

    The eCTD Implementation Guide package is available for download on the ESTRI pages under the eCTD v4.0 Step 2 page.

  • The following IWGs are currently working on a Q&As document:

  • E2B(R3) IWG

    Description :

    In June 2013, the ICH Steering Committee endorsed the establishment of an E2B(R3) IWG which is tasked to develop a Questions and Answers document to help the transition from E2B(R2) to (R3) Individual Case Safety Report (ICSR) Implementation Guide that was released in April 2013.

    Comments to :

    E2B(R3) IWG at

    E2B(R3) IG :

    The E2B(R3) Implementation Guide is available for download on the ICH E2B(R3) page on the ICH ESTRI website.

  • Q11 IWG

    Description :

    In November 2014, the ICH Steering Committee endorsed the establishment of an Q11 IWG tasked to develop a Q&As document focusing on chemical entity drug substances to clarify the Q11 Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities).

    Comments to :

    Q11 IWG at

    Q11 Guideline :

    The Q11 Guideline is available for download on the ICH Quality Guidelines page.