PRODUCT REGISTRATION DOSSIER in C.T.D format

MEDICAL DEVICE 21 CFR PART 820 (The Regulations)
1

Hello Friends,

My question is regarding the Drug Registration and what is the format for C.T.D ? is there any standard format for C.T.D , I know there is three modules for C.T.D but I see different types , please tell me if there is any standard format with an example …

Thank you all
jack

2

There are 5 module
Module 1 : Administrative
Module 2 : Summaries
Module 3 : Quality (CMC)
Module 4 : Non clinical study reports
Module 5 : Clinical study reports .

please refer the attachments for your understanding .

Ramesh Dogra

_eCTD.ppt (219.0 KB)

eCTD 2.ppt (200.5 KB)

3

Nice Post , but I think for Abbreviated NDA there is only three modules and they are :

Module I ADMINISTRATIVE DATA

Module II & III called SUMMARY OF PRODUCT CHARACTERISTICS , Moudle III is COMPOSITION .

Do we need Module 4 and 5 for all registration as well.

thank you

jack

4

Hi,

For NDA submission we need all the 5 modules whereas for the ANDA submission except module 4 all the four modules are required.

regards,
rama