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:

  • Q11 IWG

    Title :

    Questions & Answers: Selection and justification of starting materials for the manufacture of drug substances

    Description :

    This Question and Answer Document is proposed to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials and on the information that should be provided in marketing authorisation applications and/or Master Files. The focus of the Q&A document is on chemical entity drug substances.

    Step 2b :

    November 2016

    Deadline for comments :

    Deadline for comments by 23 March 2017

    Comments to :

    ICH Secretariat at step2comments@ich.org

    Q11 Q&A document :

    The Q11 Q&A document is available for download on the Quality Guideline page.

  • E11(R1) EWG

    Title :

    Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population

    Description :

    This Addendum is proposed to address new scientific and technical knowledge advances in pediatric drug development such as targeted scientific and technical issues relevant to pediatric populations, regulatory requirements for pediatric study plans, as well as infrastructures for undertaking complex trials in pediatric patient populations.

    Step 2b :

    October 2016

    Deadline for comments :

    Deadline for comments by 13 April 2017

    Comments to :

    ICH Secretariat at step2comments@ich.org

    E11(R1) Addendum document :

    The E11(R1) Addendum document is available for download on the Efficacy 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.