scispace - formally typeset

Author

Malla Reddy

Bio: Malla Reddy is an academic researcher. The author has contributed to research in topic(s): Common Technical Document & European union. The author has co-authored 1 publication(s).

Papers
More filters
01 Jan 2015
TL;DR: The Common Technical Document (CTD) provides a globally harmonized format that is accepted in many regions, avoiding the need to compile different registration dossiers for different regulatory authorities.
Abstract: The major pharmaceutical market in the world is United States. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Common. Technical Document (CTD) has become the obligatory format for the EU, Japan, Canada, Switzerland and Australia, and the recommended format in the US. An electronic CTD (ECTD) was developed in parallel with the CTD. Three ICH regions US, Europe and Japan now accept eCTD filings. The ECTD has advantages over the CTD in terms of ease of use, archiving and for life - cycle management of registration information. The ECTD specification defines the folder structure, contents, XML backbone and the Study Tagging File for clinical and nonclinical studies. The design of the ECTD documentation needs to include considerations of document granularity, templates, shell documents and regional differences in filings; for example, the needs for an Integrated Summary of Efficacy and Integrated Summary of Safety in the US. The Common Technical Document (CTD) provides a globally harmonized format that is accepted in many regions, avoiding the need to compile different registration dossiers for different regulatory authorities. It is organized into five modules. Module 1 is region specific, while Modules 2, 3, 4, and 5 are intended to be common for all regions. A regional component is included in Module 3.ECTD format enables pharmaceutical companies to submit applications to various regulatory authorities such as FDA without altering the data. ECTD format is now widely used in the United States, Japan, the European Union and Canada.