What is CTD?
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.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
In simple words "CTD is the format for registration of medicines, generally used in EU region, USA and Japan."
Note : CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.
In simple words "CTD is the format for registration of medicines, generally used in EU region, USA and Japan."
Note : CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.
The Common Technical Document is divided into five modules:
1. Administrative information and prescribing information
2. Common Technical Document summaries (Overview and summary of modules 3 to 5)
3. Quality
4. Nonclinical Study Reports (toxicology studies)
5. Clinical Study Reports (clinical studies)
The Common Technical Document is better understood with a CTD triangle which is presented below-
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| Source: ich.org |
The CTD is 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. Apart from EU region, USA and Japan, CTD format is widely accepted by many regulatory agencies across the world for registration of Medicines.
- It has revolutionised the regulatory review processes
- It led to harmonised electronic submission which, 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
All the ICH guidelines related to CTD (M4, M4Q, M4S, M4E) are presented below-
In the above guideline to get a complete idea on the sections under each module you need to focus on the content in the page- 5
M4E Guideline of ICH- This provides information on the clinical section of application.
Keywords: CTD, CTD triangle, Quality, Safety , Efficacy, M4, M4Q, M4S, M4E.
References:
http://www.wikipedia.org/
http://ich.org/
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