Pharmacy Question: Download Pharmacy PDF
What is eCTD? Difference between CTD & eCTD? How it will be prepared? Need of any Software?
Answer:
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.
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.