e- CTD Submission
Abbreviated as Electronic Common Technical Document. International Conference on Harmonization (ICT) developed an interface for consistent data organization called eCTD for exchanging data and, information from pharmaceutical industries to regulatory agencies. The CTD holds information regarding the quality, safety, and efficacy of new pharmaceuticals in the form of modules, sections, and documents. This form of CTD is used in United States, Japan, and European Union which are the member of the ICT. This electronic submission was started in Europe, where they no longer accept the paper-based application for government procedures. New Drug Application (NDA), Biologic License Application (BLA), Abbreviated New Drug Application (ANDA), Drug Master File (DMFs) and commercial Investigational New Drug (IND) must be in an eCTD format in this trending and competitive market of Drugs. Food and Drug Administration (FDA) is taking the charge of these electronic submissions according to FDA Data Standards Catalog.
The CTD Triangle :
The CTD Triangle is a backbone for the eCTD, which manages all the metadata for an application. The Common Technical Document module is split into 3 modules in a pyramid shape.
The first module, however, is not considered in CTD. It is Regional Administrative Information which includes Company Name, Drug Name, Submission Type, Submission Date, Application Number and Sequence Number.
The second module consists of Introduction, Quality overall Summary, Non-Clinical overview, Clinical Overview, Non-Clinical Written or tabulated Summary and Clinical Summary.
The third module includes 100s of high-quality documents that can be updated individually.
The fourth module comprises of Non-Clinical Study Reports which includes Study Reports, Pharmacology, Primary pharmacodynamics, Secondary Pharmacodynamics, safety pharmacology, pharmacodynamics drug interaction and, pharmacokinetics.
The Fifth module comprises of Clinical Study Reports which again includes Synopsis, Study reports, Protocol and amendments, Sample case report forms, List of International Electrotechnical Commission (IEC) or Institutional Review Board (IRB) and consent forms, List of description of investigators and sites, Signatures of principal or coordinating investigators or sponsors responsible medical officer, Listing of patients receiving test drugs from specified batch, Randomizations scheme, The Audit Reports & Certificates, and the documentation of datum process and provisional analysis plans, documentation of interlaboratory standardization process of quality assurance by agenda(if used), The publication based on the study, important publications based on the referred report, canceled patients, protocol deflections, patients excluded from the efficacy studies, demographic data, compliance and/or drug concentration data, the individual ability of the response data, the dangerous effect event listings, and the listing of particular laboratory measurements by patient.
Tammina Life Science eCTD Team Works :
Tammina Life Science experts make sure that they follow the eCTD format which is designed with a consideration that facilitates Creation, Reviews, Project Management Assistance, Information Management, Lifecycle Management, Achieving, Drug development Planning. We are aware that the eCTD is navigated by XML backbone, Table of content (TOC), bookmarks and hyperlinks. While documentation we hyperlink the cross-references to targets and finally we submit the documentation on your company behalf using CDs or through emails or portals. Tammina Life Science experts use standard tools like Adobe Acrobat 5.0 or higher, MS Office like the word, excel, PowerPoint or other word processors, spreadsheets, ASCII text, word templates, automate extraction of bookmarks and hyperlinks from word files. Tammina Life Science experts are very well versed with the format of eCTD and they follow every rule of documentation so that your company does not have to face any legal issues. We have a transparent process and quick turnaround time. Tammina Life Science also has two-stage quality checks.