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ICH Genomic Sampling Guidance: FDA Begins Consultation

Posted 02 June 2016 | By Michael Mezher 

ICH Genomic Sampling Guidance: FDA Begins Consultation

The US Food and Drug Administration (FDA) on Thursday launched a two-month public consultation for input on a recently drafted International Conference for Harmonization (ICH) guideline on genomic sampling.

Specifically, the guideline, E18 Genomic Sampling and Management of Genomic Data, seeks to create uniform standards for collecting, storing and handling genomic samples used in clinical trials.

According to ICH, the guideline "will clarify points to consider in collecting genomic samples in clinical trials and other studies and will obviate duplication of pharmacogenomics studies carried out during the research and development of new drugs."

ICH Procedure

The draft text of the ICH guideline was adopted for international consultation in December 2015 and is expected to be finalized in mid-2017. Before it's finalized, ICH's regional members (Canada, Japan, Switzerland, the US and EU) will hold their own consultations on the guideline.

Under ICH's formal procedure, guidelines are developed based on a five-step process that begins with consensus building, before developing a draft guideline to be adopted by ICH members before being implemented on an international level.

Figure 1. ICH Formal Procedure

ICH Steps 1

According to ICH's website, FDA is the last regulator to begin its national consultation on the guideline.

The European Commission (EC) ended its public consultation in May, with Swiss regulator Swissmedic saying it will follow the EC's decision; Health Canada is in the process of reviewing comments received during its public consultation, which ended in April; and Japan's Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are accepting comments for their public consultation until 20 June 2016.

ICH E18: Genomic Sampling and Management of Genomic Data

ICH began work on the guideline after its Steering Committee endorsed its development in June 2014. The issue, ICH says, is that there are no harmonized standards for collecting, storing and handling genomic samples. At the same time, drugmakers are increasingly relying on genetic data in studies used to support their products.

While regulators in the US, EU and Japan had developed their own guidances on the matter (e.g. FDA's 2013 Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and recommendations for Labeling, EMA's 2006 Reflection Paper on Pharmacogenomic Samples, Testing and Data Handling and MHLW's 2008 Guideline on General Principles for Clinical Trials Using Pharmacogenomics), ICH says these guidances left some issues unresolved.

Those issues, which include technical aspects related to the collection, processing, transportation and storage of genomic samples; generation, handling and storage of genomic data; as well as patient privacy and confidentiality are addressed in the ICH guideline.



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