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ommon Technical Document for the Registration of Pharmaceuticals
for Human Use (CTD) represents the agreed upon common format
for the preparation of a well- structured harmonized application that
will be submitted to regulatory authorities of US FDA, EMEA and Japan.
The Clinical data required in Module 2 & 5 is different for a New drug
application and a Generic application. For a CTD of Generic application
the Module 2 contain Clinical overview and clinical summary data of
the Bioequivalence/ Bioavailability studies performed and in Module
5 the study report(s) of Bioequivalence/ Comparative Bioavailability
under conditions of Fed/ Fast with their annexures. Individual Case
Report forms are also a part of this module.
As the US, EU and Japan are not geographically similar; their
documentary arrangements are also not the same. The differences
major in US and EU CTD wrt to Module 2 and 5 are;
Reanalysis of Study samples
where as this is not applicable to EMEA.
Composition of Meal Used in Fed Bioequivalence
? is a requirement for US FDA where as the same is not
required for EMEA.
or other regulatory guidance or advice should be provided for
Similar type of differences is there which needs special attention
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