regulatory ectd

regulatory ectd module-5

CTD Module 5

CTD Module 5, also known as Module 5 eCTD, refers to the fifth module within a “common technical document” (or an “electronic common technical document” in the case of the “eCTD” acronym). The overall purpose of the CTD is to provide a common format for pharmaceutical companies submitting and registering a new or altered drug. Specifically, Module 5 refers to the presentation of clinical study reports, and within the “CTD triangle” image, is one of the base modules. CTD Module 5 is the same regardless of geography so companies from any area of the world would submit clinical study reports information using the same format.

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eCTD Module 5 Structure

As mentioned above, CTD Module 5 is the section of the CTD format that allows pharmaceutical companies to present clinical study reports data and information with a clear table of contents. The eCTD Module 5 structure includes the following:

  • 5.1 Table of Contents for Module 5
  • 5.2 Tabular Listing of All Clinical Studies
  • 5.3 Clinical Study Reports (includes additional sub-sections for reports and related information on biopharmaceutic studies, food effects, reference listed drug sponsor studies, published studies, In vitro/In vivo correlations, bioanalytical methods, analytical methods, a variety of appendices, and more.)
  • 5.4 Literature References

Depending on the drug itself, Module 5 can become lengthy and difficult to organize, especially if the drug is being sold internationally. It’s essential to centralize information from the start and streamline the quick organization of submissions and registrations.

FAQs About CTD Module 5

For a quick look into the Module 5 eCTD format (and the CTD in general), here’s a few answers to frequently asked questions (FAQs).

Question

Answer

How is Module 5 different than Module 4?

Unlike Module 5, which provides clinical study reports information, Module 4 provides non-clinical data and information, which can include the results of animal testing and various free cell and biologics arrays/testing.

How should a clinical study report be referred to within Module 5?

Each clinical study report can be referred to with a short name. Throughout the module the short name can be referenced as long as it was properly introduced early on.

Do CTD Module 5 and Module 5 eCTD vary?

Content wise, these modules are the same. “eCTD” refers to the fully electronic interface of the common technical document specification. Management of one versus the other does vary somewhat as the eCTD version has an index.xml file which must be changed as specific Module 5 sections changes. (CTD Module 5 does not require the management of an index file.)

Which module should contain bioavailability and bioequivalence study data?

This data should all be included in Section 5.3 of Module 5.

What is meant by a ‘tabular listing of all clinical studies’? Is this simply a list of the study names?

The ‘tabular listing’ (5.2) is a list of all clinical studies within the submission. An example of a tabular listing is shown in Table 5.1.

Does the section on safety in Module 2 replace the section found under 21 CFR 314.50(d)(5)(v, vi) which calls for a safety and effectiveness summary? (This summary is referred to as the ISS/ISE).

If, the requirements of 21 CFR 314.50 can be met by the Module 2 summary, then the summary would fulfill the ISS/ISE requirements. However, it will likely be necessary at times to write some of what is needed in CTD Module 2 into the Module 5 appendices.

MasterControl and Module 5

The various sections of Module 5 can quickly become difficult to manage as a drug’s dossier grows. MasterControl’s Regulatory Information Management (RIM) solution streamlines a drug’s submissions and registrations management process by centralizing information across geographies, keeping information safe (and viewable only by approved suppliers and partners) and by making collaboration many times faster. For more information about MasterControl RIM, please contact a MasterControl representative.

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