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: