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:

  • E8(R1) EWG

    Title :

    Revision on General Considerations for Clinical Trials

    Description :

    The E8(R1) Guideline is proposed to incorporate the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials. The revision would propose to: identify a basic set of critical-to-quality factors that can be adapted to different types of trials to support the meaningfulness and reliability of trial results and to protect human subjects; address a broader range of trial designs and data sources; and provide an updated cross-referencing of all other relevant ICH Guidelines that should be referred to when planning clinical studies. The modernisation of ICH E8 is the first step towards the GCP Renovation initiated in 2017.

    Step 2b :

    May 2019

    Deadline for comments :

    Please refer to the E8(R1) accordeon for each Regulatory region's commenting period.

    Comments to :

    ICH Secretariat at step2comments@ich.org

    E8(R2) document :

    The E8(R1) draft Guideline is available for download on the Efficacy Guideline page.

  • E19 EWG

    Title :

    Optimisation of Safety Data Collection

    Description :

    The E19 Guideline is proposed to provide harmonised guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented

    Step 2b :

    April 2019

    Deadline for comments :

    Please refer to the E19 accordeon for each Regulatory region's commenting period.

    Comments to :

    ICH Secretariat at step2comments@ich.org

    E19 document :

    The E19 draft Guideline is available for download on the Efficacy Guideline page.

  • M10 EWG

    Title :

    Bioanalytical Method Validation

    Description :

    The M10 Guideline is proposed to provide recommendations on the scientific regulatory requirements for bioanalysis conducted during the development of drugs of both chemical and biological origins. It will also address issues on method validation by considering the characteristics of the analytical methods used in bioanalysis, e.g., chromatographic assay and ligand binding assay.

    Step 2b :

    February 2019

    Deadline for comments :

    Please refer to the M10 accordeon for each Regulatory region's commenting period.

    Comments to :

    ICH Secretariat at step2comments@ich.org

    M10 document :

    The M10 draft Guideline is available for download on the Multidisciplinary Guideline page.

  • S11 EWG

    Title :

    Nonclinical Safety Testing in Support of Development of Paediatric Medicines

    Description :

    The S11 Guideline is proposed to provide direction on the nonclinical safety studies important to support a pediatric development program.

    Step 2b :

    September 2018

    Deadline for comments :

    Please refer to the S11 accordeon for each Regulatory region's commenting period.

    Comments to :

    ICH Secretariat at step2comments@ich.org

    S11 document :

    The S11 draft Guideline is available for download on the Safety Guideline page.

  • M9 EWG

    Title :

    Biopharmaceutics Classification System-based Biowaivers

    Description :

    The M9 Guideline is proposed to address Biopharmaceutics Classification System (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognised worldwide.

    Step 2b :

    June 2018

    Deadline for comments :

    Please refer to the M9 accordeon for each Regulatory region's commenting period.

    Comments to :

    ICH Secretariat at step2comments@ich.org

    M9 document :

    The M9 draft Guideline is available for download on the Multidisciplinary Guideline page.

  • Q3D(R1) EWG

    Title :

    Revision of Q3D Cadmium Inhalation PDE

    Description :

    The Q3D(R1) Maintenance EWG is currently undertaking a revision of the Guideline, which will result in the future Q3D(R1) version, to harmonise the calculation method of the PDE level for Cadimum by inhalation.

    Step 2b :

    May 2018

    Deadline for comments :

    Please refer to the Q3D(R1) accordeon for each Regulatory region's commenting period.

    Comments to :

    ICH Secretariat at step2comments@ich.org

    Q3D(R1) document :

    The Q3D(R1) draft revision Guideline is available for download on the Quality Guideline page.

  • Q12 EWG

    Title :

    Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

    Description :

    This guideline is proposed to provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. This will promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. It will allow regulators (assessors and inspectors) to better understand the firms Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes. This new guideline is intended to complement the existing ICH Q8 to Q11 Guidelines.

    Step 2b :

    November 2017

    Deadline for comments :

    Please refer to the Q12 accordeon for each Regulatory region's commenting period.

    Comments to :

    ICH Secretariat at step2comments@ich.org

    Q12 document :

    The Q12 draft core Guideline and Q12 Annexes are available for download on the Quality Guideline page.

  • E9(R1) EWG

    Title :

    Estimands and Sensitivity Analysis in Clinical Trials

    Description :

    This Addendum is proposed to provide clarification on E9 and an update on the choice of estimand in clinical trials to describe an agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data. It focuses on statistical principles related to estimands and sensitivity analysis, not on the use or acceptability of specific statistical procedures or methods. 

    Step 2b :

    August 2017

    Deadline for comments :

    Please refer to the E9(R1) accordeon for each Regulatory region's commenting period.

    Comments to :

    ICH Secretariat at step2comments@ich.org

    E9(R1) document :

    The E9(R1) draft Guideline is available for download on the Efficacy Guideline page.

  • S5(R3) EWG

    Title :

    Detection of Toxicity to Reproduction for Human Pharmaceuticals

    Description :

    This revised ICH S5 Guideline is proposed to provide human safety assurance at least equivalent to that provided by current testing paradigms.

    Step 2b :

    August 2017

    Deadline for comments :

    Please refer to the S5(R3) accordeon for each Regulatory region's commenting period.

    Comments to :

    ICH Secretariat at step2comments@ich.org

    S5(R3) document :

    The S5(R3) draft Guideline is 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.