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# New Areas of ICH Harmonization
- URL: https://www.fdaweb.com/new-areas-of-ich-harmonization/
- Published: 2023-06-20T12:00:00.000Z
- Updated: 2026-09-14T18:39:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154722

The International Council for Harmonization (ICH) Assembly approved three new topics for harmonization at its 6/12-6/13 meeting in Vancouver, Canada. The topics are general considerations for patient preference studies, nonclinical safety studies for oligonucleotide-based therapeutics, and bioequivalence for modified-release products.

An ICH [statement](https://ich.org/pressrelease/press-release-ich-assembly-meeting-vancouver-canada-june-2023?ref=fdaweb.com) says the Assembly also was informed of the formation of a new cell and gene therapies discussion group to be a technical discussion forum for issues relating to ICH harmonization efforts in the field of cell and gene therapy products.