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# ICH Genomic Sampling Guidance to be Implemented
- URL: https://www.fdaweb.com/ich-genomic-sampling-guidance-to-be-implemented/
- Published: 2017-09-14T12:00:00.000Z
- Updated: 2026-09-14T22:50:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139626

FDA says the International Conference on Harmonization (ICH) E18 guidance *Guideline on Genomic Sampling and Management of Genomic Data*, reached Step 4 of the ICH process this month and moves now to implementation. The [document](http://www.ich.org/ichnews/newsroom/read/article/the-ich-e18-guideline-reaches-step-4-of-the-ich-process.html?ref=fdaweb.com) is intended to provide harmonized principles of genomic sampling and management of genomic data in clinical studies. The guidance pertains to genomic sampling and management of genomic data obtained from interventional and non-interventional clinical studies.

It addresses use of genomic samples and data irrespective of the timing of analyses and both pre-specified and non-pre-specified use. The focus of the guidance is on the general principles of collection, processing, transport, storage, and disposition of genomic samples or data, within the scope of an informed consent.