Tools and Technologies used in eCTD submission
Common Technical Document is defined as a set of specifications which is used for making any application for registration of medicines. This system is used across US,EU and Japan Australia etc. CTD is maintained by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The main purpose of this Document set is to combine all safety, efficacy and quality data which are required for regulatory review process by Authorities ultimately for approval of drug registration. As we are in 2020, The hard copy of documents are not practical in majority countries. All the submissions to the Regulatory Authority shall be done through various eCTD software's online. The harmonized CTD specifications are given by ICH guidelines ( Multidisciplinary guidelines M4 ). The eCTD is defined as an interface for in...