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 IWGsto 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 regulatory consultation:

  • E18

    Title :

    Genomic Sampling and Management of Genomic Data

    Description :

    This new ICH E18 guideline is proposed to provide guidance on genomic sample collection to evaluate efficacy and safety of a drug for regulatory approval. Harmonisation across regions on this topic will maximise the information gathered from the studies for e.g., sample collection and analysis (including ethical considerations) and facilitate implementation of pharmacogenomics for the benefit of all stakeholders.

    Step 2b :

    December 2015

    Deadline for comments :

    20 June 2016

    Comments to :

    ICH Secretariat at step2comments@ich.org

    E18 draft Guideline :

    The E18 draft Guideline is available for download on the Efficacy Guideline page.

  • 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 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.

  • Q11 IWG

    Description :

    In November 2014, the ICH Steering Committee endorsed the establishment of a Q11 IWG tasked to develop a Q&As document focusing on the selection and justification of starting materials for chemical entity drug substances to provide further clarification on this specific concept introduced in the Q11 Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities).

    Comments to :

    Q11 IWG at q11@ich.org

    Q11 Guideline :

    The Q11 Guideline is available for download on the ICH Quality Guidelines page.

  • S3A IWG

    Description :

    In October 2014, the ICH Steering Committee endorsed the establishment of a S3A IWG tasked to develop a S3A Q&As document intended to facilitate the implementation of the S3A Guideline and especially to address the benefit and use of microsampling techniques in main study animals.

    Comments :

    S3A IWG at s3a@ich.org

    S3A Guideline :

    The S3A Guideline is available for download on the ICH Safety Guidelines page.

  • S9 IWG

    Description :

    In October 2014, the ICH Steering Committee endorsed the establishment of the IWG on S9 to develop Q&As intended to facilitate the implementation of the S9 Guideline clarifying the scope of the Guideline as well as its interpretation and implementation.

    Comments to :

    S9 IWG at s9@ich.org

    S9 Guideline :

    The S9 Guideline is available for download on the ICH Safety Guidelines page.