The ICH guideline categories for each CTD Modules provide harmonized structure and format for presenting information on a new drug. The codes and what they mean are; • Module 1) MR (R3) Overall organization of the CTD. Administrative information and prescribing information and specific to each region.<br> • Module 2: M4Q (R1) Quality overall summary (QOS), and M4E (R1) Clinical overview and clinical summary – efficacy. • Module 3 M4Q (R1) Quality. • Module 4: M4S (R2) Safety. • Module 5: M4E (R1) Efficacy. Reference: ICH harmonization for better health. CTD M4: The common Technical Document. http://www.ich.org/products/ctd.html. Accessed October 11, 2015.

Definitions: The electronic Code of Federal Regulations Title 21, Chapter 1, Subchapter D, Part 314.3 contains a list of definitions. There are many terms that are listed in the regulation for applications for FDA approval to market a new drug. A general understanding of these terms is needed in order to ensure an appropriate and accurate application process is completed. It would be the applicant’s best interest to be familiar with all definitions in order to better understand the application process for a new drug

Electronic Code of Federal Regulations Title 21, Chapter 1, Subchapter D, Part 314.3 defines an applicant as: “Applicant means any person who submits an application or abbreviated application or an amendment or supplement to them under this part to obtain FDA approval of a new drug or an antibiotic drug and any person who owns an approved application or abbreviated application.” The definition includes those who already own an approved application or abbreviated application and not just those who are applying for the first time.