원문정보
초록
영어
The Common Technical Document(CTD) is part of the ICH(International Conference on Harmonization) program for developing global, harmonized guidelines for the contents and format of new drug and biologic products applications to be submitted to regulatory agencies in the ICH regions. The CTD is divided into 5 modules : 1. Region specific administrative and prescribing information 2. High level summary 3. Quality -chemical, pharmaceutical and biological documentation 4. Non-clinical study reports 5. Clinical study reports. The potential advantages of CTD can be extensive. A pharmaceutical companies could save in resources and time, so that they could facilitate simultaneous submissions in ICH regions. Also, CTD could provide a more efficient evaluation process with regulators, as well. Finally, a faster availability of new medicines is expected in the future. The CTD was first agreed upon in 2000 and now required in
the EU, Japan, Canada and Switzerland and is strongly encouraged in the US. In Korea, CTD submissions will be accepted by KFDA for New Drug Application in March, 2009. In this session, a general overview of the CTD documents and a detailed introduction with each modules will be presented. The background, scientific and regulatory aspects of CTD documents will be focused.