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, Japan, USA and Canada are encouraged to submit their comments to their respective Regulatory Authorities.

Draft Step 2b Guideline currently undergoing regulatory consultation:

  • M4E(R2)

    Title :

    Revision of M4E Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH

    Description :

    The Revision of the M4E(R1) is proposed to include greater specificity on the format and structure of benefit-risk information with the goal of harmonising the presentation of this information in regulatory submissions to facilitate communication among regulators and industries. The proposed revision focused only on Section 2.5.1 on Product Development Rationale and Section 2.5.6 on Benefits and Risks Conclusions.

    Step 2b :

    August 2015

    Deadline for comments :

    29 February 2016

    Comments to :

    ICH Secretariat at step2comments@ich.org

    M4E(R2) Guideline :

    The M4E(R2) revised Guideline is available for download on the CTD page.

  • E6(R2)

    Title :

    Integrated Addendum: Good Clinical Practice

    Description :

    This Integrated Addendum to ICH E6(R1) is proposed to modernise the ICH E6 Guideline by supplementing with additional recommendations which will facilitate broad and consistent international implementation of new methodologies.

    Step 2b :

    June 2015

    Deadline for comments :

    31 January 2016

    Comments to :

    ICH Secretariat at step2comments@ich.org

    E6(R2) Addendum :

    The E6(R2) Addendum is available for download on the Efficacy Guideline page.

  • M7(R1)

    Title :

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

    Description :

    This Addendum to ICH M7 is proposed to summarise known mutagenic impurities commonly found or used in drug synthesis. The intent of this Addendum is to provide useful information regarding the acceptable limits of known mutagenic impurities/carcinogenic and supporting monographs.

     

     

    Step 2b :

    June 2015

    Deadline for comments :

    31 January 2016

    Comments to :

    ICH Secretariat at step2comments@ich.org

    M7(R1) Addendum :

    The M7(R1) Addendum is available for download on the Multidisciplinary Guideline page.

  • Q3C(R6)

    Title :

    Impurities: Guideline for Residual Solvents - PDE for Triethylamine and PDE of Methylisobutylketone

    Description :

    The Revision of the Q3C(R5) Guideline is proposed to include a new PDE for triethylamine and revise the PDE of methylisobutylketone (MIBK) due to toxicity data newly available.

    Step 2b :

    June 2015

    Deadline for comments :

    31 December 2015

    Comments to :

    ICH Secretariat at step2comments@ich.org

    Q3C(R6) Guideline :

    The Q3C(R6) revision Guideline is available for download on the Quality 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.