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 Implementation Working Group (IWG)). Indeed, the ICH Assembly establishes IWGs to assist in Guideline implementation, as needed. Such additional implementation guidance/advice is usually developed in the form of Questions and Answers (Q&As). Note that stakeholders from ICH regions are encouraged to submit their comments to their respective Regulatory Authorities.

Draft Step 2b Guideline currently undergoing public consultation:

  • E9(R1) EWG

    Title :

    Estimands and Sensitivity Analysis in Clinical Trialsnufacture of drug substances

    Description :

    This Addendum is proposed to provide clarification on E9 and an update on the choice of estimand in clinical trials to describe an agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data. It focuses on statistical principles related to estimands and sensitivity analysis, not on the use or acceptability of specific statistical procedures or methods. 

    Step 2b :

    August 2017

    Deadline for comments :

    Please refer to the E9(R1) accordeon for each Regulatory region's commenting period.

    Comments to :

    ICH Secretariat at step2comments@ich.org

    E9(R1) document :

    The E9(R1) draft Guideline is available for download on the Efficacy Guideline page.

  • S5(R3) EWG

    Title :

    Detection of Toxicity to Reproduction for Human Pharmaceuticals

    Description :

    This revised ICH S5 Guideline is proposed to provide human safety assurance at least equivalent to that provided by current testing paradigms.

    Step 2b :

    August 2017

    Deadline for comments :

    Please refer to the S5(R3) accordeon for each Regulatory region's commenting period.

    Comments to :

    ICH Secretariat at step2comments@ich.org

    S5(R3) document :

    The S5(R3) draft Guideline is available for download on the Safety Guideline 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.