The Common Technical Document (CTD)
is a set of specification for application dossier for the registration of
Medicines and designed to be used across Europe, Japan and
the United States.
It was developed by the European Medicines
Agency (EMA,Europe), the Food and Drug
Administration (FDA, U.S.) and the Ministry of Health, Labour
and Welfare (Japan).
The CTD is maintained by the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The agreement to assemble all the Quality, Safety
and Efficacy information in a common format (called CTD - Common Technical
Document ) has revolutionised the regulatory review processes, led to
harmonised electronic submission that, in turn, enabled implementation of good
review practices.
For industries, it has eliminated the need to
reformat the information for submission to the different ICH regulatory
authorities.
CTD
Triangle
CTD Triangle
The CTD is organised into five modules. Module 1 is
region specific and Modules 2, 3, 4 and 5 are intended to be common for all
regions. In July 2003, the CTD became the mandatory format for new drug
applications in the EU and Japan, and the strongly recommended format of choice
for NDAs submitted to the FDA.
Source: Official wesite of ICH: http://www.ich.org/products/ctd.html
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