Volume : II, Issue : IV, April - 2013

The Common Technical Documentits contents, History, Advantages and complexities

Pushpinder Paul

Abstract :

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, Labor and Welfare (Japan). The CTD is maintained by the International Conference on Harmonization 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 revolutionized the regulatory review processes, led to harmonized 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. The CTD is organized 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 NDA submitted to the FDA. An electronic version of the Common Technical Document (eCTD) can be produced using the information developed by the eCTD Implementation Working Group. After the United States, European Union and Japan, the CTD has been adopted by several other countries including Canada and Switzerland

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Article: Download PDF   DOI : 10.36106/ijsr  

Cite This Article:

Pushpinder Paul The Common Technical Documentits contents, History, Advantages and complexities International Journal of Scientific Research, Vol.II, Issue.IV April 2013

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