What are the modules of common technical affairs

Common Technical Document (CTD) is the format used in applying New medicines that is Drug product, Drug Substance.

It is a document submitted for Regulatory bodies for approval of Mew medicines ( Drug product, Drug Substance.)

CTD has 5 modules that gives information of applied New medicine .

Module 1 has Administrative Information where it will have patent information and prescription details of how the dosage shall be used and the Information also is provided in regional language.

Module 2 is the summary of Module 3, Module 4 and Module 5 that has Quality, Clinical and Non-Clinical data of the Modules

Module 3 has Drug product or Drug substance Manufacturing details with Specification, STPs, BPCRs, Cleaning validation Records, Stability Records and all other information related to Drug Manufacturing and Manufacturing is included in this Module.

Module 4 has non-clinical information Pre-clinical studies like pharmacology and Toxicology including safety data from the studies.

Module 5 has Clinical study that has Human trails demonstrates Drug Efficacy.