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# ICH Working on Generic Drug Standards Harmonization
- URL: https://www.fdaweb.com/ich-working-on-generic-drug-standards-harmonization/
- Published: 2019-02-07T12:00:00.000Z
- Updated: 2026-09-15T01:01:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143331

The International Conference on Harmonization (ICH) has issued a “[reflection paper](https://www.ich.org/fileadmin/Public%5FWeb%5FSite/ICH%5FProducts/Reflection%5FPapers/ICH%5FReflectionPaper%5FGenericDrugs%5FFinal%5F2019%5F0130.pdf?ref=fdaweb.com)” outlining a strategic approach for developing and enhancing ICH guidelines to support harmonization of scientific and technical standards for generic drugs. As part of the approach, the paper outlines recommendations to develop a series of ICH guidelines on standards for demonstrating equivalence for **(1)** non-complex dosage forms, and **(2)** more complex dosage forms and products. To accomplish the work, it recommended establishment of a generic drug discussion group to assist in assessing the feasibility of harmonization of standards for generic drugs and to prioritize work areas.

Moving the process forward, ICH has issued a [description](https://www.ich.org/fileadmin/Public%5FWeb%5FSite/ICH%5FProducts/Reflection%5FPapers/ICH%5FIGDG%5FRemit%5FFinal%5F2019%5F0130.pdf?ref=fdaweb.com) of an informal generic drug discussion group that will be a technical discussion group for issues relevant to harmonization of scientific and technical standards for generic drugs. The group is to recommend areas for harmonization and assess feasibility of harmonization of various topic areas within existing regional regulatory frameworks.