Types of information to be submitted in CTD

There are two main categories of Data required when submitting CTD to obtain the marketing authorization

A-????Administrative Data (Submitted in module 1): it doesn’t contain any technical information.

B-?????Technical data (to support the safety, efficacy and quality of the product) and classified as the following:

1-?????Quality Data (Module 3)

2-?????Non-Clinical Data ?(Module 4)

3-?????Clinical Data (Module 5)

? Clinical & non-clinical data submitted to prove the safety and efficacy and they are mainly related to the molecule itself. These data are submitted by the innovator of the molecule and mostly the generic companies are exempted from submitting these data with few exceptions as:

• Bioequivalence study (it is considered a clinical study and required for generic products where it is applicable “for certain dosage forms”)
• Drug regulatory authority may ask to provide supporting literatures for proving safety and efficacy (usually when you are the first generic to submit the dossiers and the innovator is not registered in this authority)

? Quality data and it is related to the drug product so it is required from all companies regardless it is innovator or generic because each product has its own quality attributes.

• This module mainly cover the specifications of raw materials, the manufacturing processes, the analytical procedures, certificates of analyses, validation studies, the pharmaceutical development and stability data for both drug substance, Excipients, packaging materials and drug product.