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 Q&As 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 E2BR3@ich.org

    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 a Q11 IWG tasked to develop a Q&As document focusing on the selection and justification of starting materials for chemical entity drug substances to provide further clarification on this specific concept introduced in the Q11 Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities).

    Comments to :

    Q11 IWG at q11@ich.org

    Q11 Guideline :

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

  • S3A IWG

    Description :

    In October 2014, the ICH Steering Committee endorsed the establishment of a S3A IWG tasked to develop a S3A Q&As document intended to facilitate the implementation of the S3A Guideline and especially to address the benefit and use of microsampling techniques in main study animals.

    Comments :

    S3A IWG at s3a@ich.org

    S3A Guideline :

    The S3A Guideline is available for download on the ICH Safety Guidelines page.

  • S9 IWG

    Description :

    In October 2014, the ICH Steering Committee endorsed the establishment of the IWG on S9 to develop Q&As intended to facilitate the implementation of the S9 Guideline clarifying the scope of the Guideline as well as its interpretation and implementation.

    Comments to :

    S9 IWG at s9@ich.org

    S9 Guideline :

    The S9 Guideline is available for download on the ICH Safety Guidelines page.