What is eCTD? Difference between CTD & eCTD? How it will be
prepared? Need of any Software?
Answer Posted / rohaan vijay chavan
The guidance on marketing applications for drugs and
biologics, known as the Common Technical Document (CTD), was
finalized by the International Conference on Harmonization
(ICH) in 2003. Today the CTD format is mandatory for
paper-based marketing applications in Europe, Japan, Canada,
and other regions, and is highly recommended by FDA.
The eCTD format has become mandatory in key regions for
electronic submissions. Since January 2010, the European
Medicines Agency has required all applications in the
centralized procedure use the eCTD format. Since January
2008 FDA CDER has required all electronic submissions be in
the eCTD format. FDA CBER requires the eCTD format for
priority review and rolling submissions.
Is This Answer Correct ? | 41 Yes | 11 No |
Post New Answer View All Answers
hello,am milan mohite,i have completed B.PHARM,in 2008.and now do M.B.A from ignou,and D.P.P.M,from IPER{PUNE},please suggest me best coaching institute in pune for drug inspector,and send me model question paper for prepration of D.I. on my e.mail id - milan_mohite@yahoo.in Thanks.
Why we use potassium hydrogen pthalate for determination of calibration in Total organic carbon
What should be Step wise the sterlization procedure for Dry Powder injection facility (from Starting)?
How to select HPLC column for a particular product?
What should be the minimum limit of a working standard?
hai,i had completed my b.pharmacy.i want the coaching centres for drug inspector exam at hyderabad,pls help me nd wen wil b the DI exam conducted in 2012 mostly,pls also forward the model papers.. pls reply me at jyothipasam@gmail.com
what is purpose of slow,medium,fast sampling in process validation ?
A patient reports not experiencing the desired relief from their anxiety symptoms after a few weeks of Alprazolam treatment. How would you assess and adjust their treatment plan?
what is the difference of vaccum pressure and vapour pressure ?
How would you make a physician to prescribe your medicine rather than that of the competitor?
What is the difference between sonication and homozinization?
In Stability testing if significant change occurs then what will be the action plan?
Can we quantify bound water by KF titrator ?
If calibration of 12 bowl dissolution apparatus does not meets single stage procedure, how can you precede calibration?
when we calibrate uv for control of wavelength we scan for 200 to 800 nm but we get the result only for some specific wavelength how we confirm for all other wavelength?