16 October 2017

Following its last meeting in Montreal in June 2017, the International Council for Harmonisation (ICH) has continued to progress its work with the adoption of new guidelines on pediatric clinical trials and genomic data and the publication of new draft guidance on estimands and reproductive toxicity.

ICH is also delivering on its commitment to improving transparency and openness, and has begun publishing the membership of its working parties for the first time.

New guidance on pediatric clinical trials and genomic data

The first guidance relates to clinical trials in children and complements the earlier 2000 guidance. It addresses new scientific and technical knowledge advances in pediatric drug development and updates certain aspects of the ICH E11 Guideline adopted in 2000. The ICH E11(R1) amendment includes guidance on ethical considerations, age classifications and subgroups for children, pediatric formulations and guidance on extrapolation in pediatric drug development and trial design.

ICH has also adopted a new harmonised E18 Guideline on the collection of genomic information for use in the evaluation of efficacy and safety of a drug for regulatory approval. The guideline clarifies that genomic data should be collected in clinical trials and other studies in accordance with certain methodologies during drug development and throughout the product life cycle; the guideline also covers the storage and retention of genomic samples.

In addition to these new international harmonisation guidelines, ICH has also adopted the ICH Q11 Q&A document. This is intended to provide additional clarification and 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.

The Expert Working Group for the ICH M8 Electronic Common Technical Document (eCTD) also adopted the eCTD v3.2.2 Q&A v1.30 and Study Tagging Files (STF) Stylesheet v2.3. Further to a change request, the Study Tagging Files (STF) Stylesheet was updated to version v2.3 and the eCTD v3.2.2 Q&A was updated accordingly to version v1.30, to reflect the change. All electronic standards document are available on the Electronic Standards for Transfer of Regulatory Information (ESTRI) at http://estri.ich.org.

All these three documents now enter the implementation stage (Step 5) in the ICH regions.

Consultation opens on estimands and reproductive toxicity

The draft ICH E9(R1) Addendum on defining appropriate estimands for a clinical trial/sensitivity analyses has been published for consultation. The proposed addendum to the 1998 guideline on Statistical Principles for Clinical Trials seeks to promote harmonised standards on the choice of estimand in clinical trials and define an agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data.

The other draft guideline published for consultation is ICH S5(R3) on the detection of toxicity to reproduction for human pharmaceuticals. The revision proposes efficiencies in the conduct of reproductive toxicity studies, including novel models to complement traditional methods when warranted. The proposal seeks to enhance human risk assessment, while also reducing potentially animal use. The revision uses experience gained since the last revision in 2000 with the testing of pharmaceuticals as well as developments in scientific, technological and regulatory knowledge.

Comments on either draft guideline may be e-mailed to the ICH Secretariat however stakeholders from ICH Regions are encouraged to submit their comments to their respective regulatory authority.

Publishing membership of expert working groups adds new level of transparency

Beginning on 16 October 2017 ICH began publishing the membership of its Expert Working Groups. While these experts represent the regulatory and industry association parties that nominate them, this new level of transparency will bring a novel understanding of who contributes to the development of guidelines as well as the roles they play.

A number of improvements have also been made to the ICH website, including information on how the ICH Association is funded and information on training on ICH Guidelines.

The next ICH meeting will take place on 11 – 16 November 2017 in Geneva, Switzerland.



The new adopted guidelines are available on the relevant Efficacy Guidelines and Quality Guidelines pages of the ICH website.

The draft guidelines open for consultation are available on the Public Consultation page of the ICH website, including information on how to provide comments.

This press release, together with more information on the work of ICH, can be found on its website: www.ich.org.

For further information, please contact the ICH Secretariat at pressrelease@ich.org.

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