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ICH M4Q(R2): The Common Technical Document for the Registration of Pharmaceuticals for Human Use – Quality
The U.S. Food and Drug Administration announced the availability of a draft guidance for industry titled " M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality. " Prepared under the International Council for Harmonisation (ICH), this draft establishes a globally harmonized framework for organizing and presenting quality data in registration applications for human medicines. It updates the CTD's quality section to enhance registr
Sharan Murugan
4 hours ago3 min read