Chemistry Reference
In-Depth Information
Figure 12.1.
A diagrammatic representation of the CTD [4].
applications and related submissions. Conformance with the CTD guidance also ensures
that these four modules are provided in a format acceptable to the regulatory authorities
in the ICH region. A diagrammatic representation of the CTD is presented in Figure 12.1
and the location of regulatory requirements in relationship to various CTD modules is
summarized in Table 12.1.
12.3.1 Module 1: Administrative Information and Prescribing
Information
This module contains documents speci
c to each region; for example, application forms
or the proposed label for use in the region. The content and format of this module are
speci
ed by the relevant regulatory authorities. In the United States, the documents in
this section include FDA form 356h; comprehensive table of content; administrative
documents such as patent information and certi
cation, and user
fee cover sheet; prescribing information; and the annotated labeling text for the NDAs, as
described in 21 CFR 314.50(c)(2)(i) and 21 CFR 201.57, or the labeling comparison for
the ANDAs, as described in 21 CFR 314.94(a)(8).
cation, debarment certi
