Module 1 is neither a part of the ICH or the CTD. This is information that may or may not be requested depending on which agency the product is getting filed with. Module 2 really applies to all of the following ICH portions, as it is a summary of the specific information in the following modules: M4Q(R1) Quality per ICH or Module 3; M4S(R2) Safety per ICH or Module 4; and M4E(R1) Efficacy per ICH or Module 5.

The applicant would be the person who signs the Form FDA 356h, or has signed a previous form belonging to an approved product.

The application form is Form FDA 356h. It includes a checklist that must be completed by the applicant. When the applicant signs the form and submits it to the FDA, they are declaring that all the information included in the application is true and accurate to their knowledge. FDA Regulatory Affairs, 3rd Ed. Mantus and Pisano, pgs 88-92. 2014.

Any and all patent information about the drug needs to be disclosed in the NDA because it helps determine or protect the applicant from whether or not the drug included in the NDA might infringe on a patent.

"of this section for each patent that claims the drug or a method of using the drug that is the subject of the new drug application or amendment or supplement to it and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug product"

The CTD relates because in module 1 of the CTD is the same information requested for patent information on the NDA, in the same format.

I think that all of the definitions are important to understand when putting together an application to the FDA. Some definitions, I think don't really need much explanation such as Act, Applicant, FDA, Drug Product, Drug Substance, and Specification. On the other hand, applicants will need to know what type of application they are filing, and then the subsequent aspects or requirements for each type of application. For example, an NDA will not require any type of reference listed drug or RLD. Some terms apply to both ANDAs and NDAs, such as approval letter, class 1 and class 2 resubmission, and complete response letter, just to name a few.