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:

  • No Step 2b Guideline currently under consultation

  • 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.