The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.
This resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also discussed.
The book is organized into six practical segments:
• CTD, eCTD, Module 1, and Environmental Risk Assessment
• CTD Summaries
• Quality Topics
• Nonclinical Topics
• Clinical Topics
• Other Topics, such as drug-device combination products