Biomedical Engineering Reference
In-Depth Information
Module 1
Region-Specific Information
(Not part of the CTD)
Module 2
Overviews and summaries
of information on
drug quality, preclinical
studies, and clinical trials
found in Modules 3-5
Module 3
Drug Quality
Module 4
Nonclinical Study Reports
Module 5
Clinical Study Reports
Fig. 2 Organization of the Common Technical Document (CTD). The CTD is
organized into 5 modules. Module 1 is region-specific and modules 2 through
5 are common for all regions. Modified from [
20
]
MAA must demonstrate that the new drug is effective for its
intended use and that the benefits of its use outweigh the known
risks. It should also provide enough information to determine if the
proposed labeling for the drug is appropriate and what additional
information the labeling may need to contain. It should also pro-
vide sufficient information about the manufacturing process to
allow regulatory agencies to determine if the methods and controls
used are sufficient to maintain drug quality, identity, strength, and
purity. Some of this information may be adapted from the IND or
Clinical Trial Application submitted earlier in the process [
19
,
20
].
The general format of the CTD is shown in Fig.
2
. The CTD is
divided into five modules. The first module contains region specific
information (required by the specific regulatory authority receiving
the document), while modules 2 through 5 are intended to be
common for all regions. Module 2 contains overviews and summa-
ries of the detailed information found in modules 3, 4, and 5 on
drug quality, non-clinical studies, and clinical trials, respectively.
Detailed guidelines for each section of the CTD can be downloaded
from the ICH website [
20
].
The US FDA also provides detailed guidance documents that
can be used to put together an NDA for regulatory approval in the
US [
19
]. As mentioned above, a CTD prepared for submission for
regulatory approval in the EU should also be an acceptable format
for an FDA NDA. Nonetheless, all of the relevant guidance docu-
ments provided by the FDA should also be consulted to make sure
that all of the specific details that the FDA requires in each section
(e.g. microbiology, toxicology, manufacturing, etc.) for your
specific drug class are included in your application.
