CMC Sections of Regulatory Filings and CMC Regulatory Compliance During Investigational and Postapproval Stages

The chemistry, manufacturing, and controls (CMC) section of a regulatory filing

[investigational new drug (IND), IND amendments, IND annual reports, new

drug application (NDA) or biologics license application (BLA), postapproval

CMC supplements, NDA annual reports] contains detailed information pertain-

ing to the characteristics, manufacturing, and quality aspects of the drug sub-

stance and drug product. Under the International Conference on Harmonization

(ICH) common technical document (CTD) format,1 the CMC section is referred

to as the quality section and the structure is outlined in the ICH CTD guidance.2

This chapter first discusses the details of the quality section of a CTD, followed

by how CMC changes are managed during the IND development phases and

postapproval stages. As this book addresses the Food and Drug Administration

(FDA) regulatory affairs, the focus of the discussions is primarily based on the

U.S. FDA expectations and requirements.