Information regarding chemistry, manufacturing and controls (CMC) for drugs is an important and detailed section in a dossier to support clinical studies and marketing applications. This information must be updated throughout a drug’s lifecycle. The required content and format of the CMC section of various application types are described in guidance documents from both the International Conference on Harmonization (ICH) and individual regions.
This course provides an overview of the CMC section of dossiers. It discusses the CMC information necessary to support original investigational applications; identifies CMC changes that would require investigational application amendments; and provides the CMC information necessary to support a marketing application, information on required postapproval submissions—including Drug Master Files (DMFs)—and information on CMC specific guidances.
The CMC section is synonymous with the quality section in some formats, such as the Common Technical Document (CTD). For ease of review, this course will describe it generically as the CMC section.