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:

  • Q7 IWG

    Description:

    In October 2012, the ICH Steering Committee endorsed the establishment of the IWG on Q7 to work on technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - in order to harmonize expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs.

    Comments to:

    Q7 IWG at Q7@ich.org

    Q7 Guideline:

    The Q7 Guideline is available for download on the ICH Quality Guidelines page.