Challenges Faced During eCTD and CTD Filling Procedures for USFDA and Canada
Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical Industry as it become compulsory for filing procedures. 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). Electronic common technical documentis an interface used by applicants of marketing authorisation for medical products to submit regulatory affairs document to the agency concerned. The purpose of this article is to present a concise overview of challenges faced during eCTD & CTD submissions in United States and Canada. A regulatory process, by which a person/organization/ sponsor/innovator gets authorization to launch a drug in the market, is known as registration process. The registration process will be done by submitting technical information to the authority
Keywords: electronic common technical document (ECTD)/ (CTD), International conference on hormonisation (ICH), Drug registration process.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).