You are invited to provide comments on any of the draft (Step 2) 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, US and Japan are encouraged to submit their comments to their respective Regulatory Authorities.

Draft Step 2 Guidelines currently undergoing regulatory consultation:

  • E2B(R3)

    Description:

    The E2B(R3) Expert Working Group has finalised the draft ICH Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs), Data Elements and Message Specification which includes the key parts of the updated E2B(R3) Guideline. As there are significant differences between the data models for E2B(R2) and E2B(R3), a Backwards and Forwards Compatibility (BFC) document has been produced as an Appendix to the Implementation Guide to define the compatibility of data elements between the two versions of the specification.

    Step 2:

    June 2011

    Deadline for comments:

    March 2012

    Comment to:

    ICH Secretariat at step2comments@ich.org

    ICSR IG:

    The ICSD Implementation Guide is available for download on the ESTRI pages under the ICSR – Public Consultation page

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

  • M3(R2) IWG

    Description:

    In December 2009, the ICH Steering Committee endorsed the establishment of the IWG on M3(R2) that provides Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.

    Comments to:

    M3(R2) IWG at M3-R2@ich.org

    M3(R2) Guideline:

    The M3(R2) Guideline is available for download on the ICH Multidisciplinary Guidelines page.

  • E3 IWG

    Description:

    In June 2011, the ICH Steering Committee endorsed the establishment of the IWG on E3 that provides Guidance on Structure and Content of Clinical Study Reports.

    Comments to:

    E3 IWG at E3@ich.org

    E3 Guideline:

    The E3 Guideline is available for download on the ICH Efficacy Guidelines page.

  • E14 IWG

    Description:

    In April 2010, the ICH Steering Committee endorsed the establishment of the IWG on E14 to work on a revision of the first set of E14 Q&As on Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs, finalised in June 2008.

    Comments to:

    E14 IWG at E14@ich.org

    E14 Guideline:

    The E14 Guideline is available for download on the ICH Efficacy Guidelines page.