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 Guideline currently undergoing regulatory consultation:

  • M7

    Title:

    Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

    Description:

    This new Guideline is proposed to offer guidance on analysis of structure activity relationships (SAR) for genotoxicity.

    Step 2:

    February 2013

    Deadline for comments:

    14 June 2013

    Comments to:

    ICH Secretariat at step2comments@ich.org

    M7 Guideline:

    The M7 draft Guideline is available for download on the Multidisciplinary Guideline page.

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

  • E2C(R2) IWG

    Description:

    In November 2012, the Steering Committee endorsed the establishment of the IWG on E2C(R2) to assist with the implementation of the new revision (R2) of the E2C Guideline finalised in November 2012. This revision to E2C has introduced new concepts and principles linked to an evolution of the traditional PSUR from an interval safety report to cumulative benefit-risk report and with a change in focus from individual case reports to more aggregate data evaluation.

    Comments:

    E2C(R2) IWG at E2C-R2@ich.org

    E2C(R2) Guideline:

    The E2C(R2) Guideline is available for download on the ICH Efficacy Guidelines page.

  • 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.

  • 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.