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:

  • S9 IWG

    Title :

    Questions &Answers on Non Clinical Evaluation for Anticancer Pharmaceuticals

    Description :

    This Question and Answer Document is proposed to promote a consistent interpretation and implementation of the S9 Guideline by ICH member regions and Observers and, of additional benefit, to continue progress in the 3Rs of Reduction, Refinement, and Replacement.

    Step 2b :

    June 2016

    Deadline for comments :

    27 October 2016

    Comments to :

    ICH Secretariat at step2comments@ich.org

    S9 Q&A document :

    The S9 Q&A Document is available for download on the Safety Guideline page.

  • E17 EWG

    Title :

    Multi-Regional Clinical Trials 

    Description :

    This new Guideline is proposed to provide guidance on general principles on planning/designing Multi-Regional Clinical Trial (MRCT). It will complement the guidance on MRCTs provided in ICH E5(R1) Guideline, facilitate MRCT data acceptance by multiple regulatory agencies and promote conducting MRCT appropriately. 

    Step 2b :

    June 2016

    Deadline for comments :

    31 January 2017

    Comments to :

    ICH Secretariat at step2comments@ich.org

    E17 draft Guideline :

    The E17 draft Guideline is available for download on the Efficacy Guideline page.

  • S3A IWG

    Title :

    Q&As: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling

    Description :

    The ICH S3A Q&A document has been developed to provide addition guidance and facilitate the interpretation of the S3A Guideline; and especially to address the benefit and use of microsampling techniques in main study animals.

     

     

    Step 2b :

    May 2016

    Deadline for comments :

    8 September 2016

    Comments to :

    ICH Secretariat at step2comments@ich.org

    S3A draft Q&A document :

    The S3A draft Q&A document available for download on the Safety 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.

  • 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.