eCTD Module 4

In the CTD triangle, Module 4 is one of the base modules, and like modules 2, 3 and 5, are common to all geographic markets. Information gathered during the nonclinical data gathering phases (and documented in Module 4) will include pharmacological, pharmacokinetic and toxicological evaluations (both small molecule and biologic). It is also important to note that some of the guidance documents related to Module 4 are referred to as “M4” documents. Specifically the United States’ Food and Drug Administration (FDA) provides an M4 guidance.

CTD Module 4: Table of Contents and Organization

Every CTD module, including Module 4, has a strict and unwavering table of contents (only Module 1 will vary somewhat). Module 4 requires the following table of contents:

Module 4: Nonclinical Study Reports:

• 4.1 Table of Contents of Module 4
• 4.2 Study Reports
• 4.3 Literature References

Within sections 4.1, 4.2 and 4.3, essential information collected from nonclinical study reports should be documented. Sections should include information regarding the pharmacological, pharmacokinetic and toxicological evaluation of pharmaceuticals, the identification of safety doses in humans, carcinogenicity concerns and many additional factors common to the nonclinical determination of drug safety.

It is essential to keep Module 4 information secure, streamlined (in order) and reviewed by the appropriate personnel. Failure to do so can result in late drug registration or no registration at all.

ICH Module 4

As mentioned above, CTD Module 4 is also referred to as ICH Module 4. Only the names are distinct however, as the documentation is the same. The term ICH comes from the organization (International Council on Harmonisation) that originally created the CTD for the purposes of harmonizing and streamlining information prepared for pharmaceutical submissions and registrations.

MasterControl Manages Module 4

MasterControl has a long history of helping life science companies get their life-improving products to market faster. MasterControl’s Regulatory Information Management (RIM)™ solution is designed specifically to alleviate the pains of managing regulatory submissions and product registrations. MasterControl RIM provides a highly secure centralized location that provides online access to approved personnel to document, track, review and collaborate on Module 4 related information from anywhere in the world. For more information regarding MasterControl RIM, please contact a MasterControl representative.