Common Technical document (CTD) is a hit word of 21st century pharmaceuticals as approval of this document in particular country provides market access to your pharmaceutical product. Electronic common technical document (eCTD) is computerised document that provides ease of access to reviewers and regulatory bodies for reviewing of data in marketing authorization application.
Advent of eCTD
International Conuncil on Harmonization (ICH) started development of guidelines of CTD since 2002. Immediately after the same, since 2003, EU started accepting eCTD and since 1 July 2015, they mandated eCTD for all product types. Similarly, in US, since May, 2015 eCTD final guidance was published and from May 2017, they have started full fledged acceptance of eCTD applications.
It is therefore essential for pharmaceutical regulatory professionals to understand and learn about eCTD submissions.
Advantages of eCTD
eCTD has provided distinct advantages compared to paper CTDs as it helps in managing of mountain of information of dossier. Also, eCTD files are refernced in XML backbone which allows them to be viewed by any web browser and thus can be loaded on web server. This reduces clutter of papers on desk of reviewers and maintains its desk clean, neat and tidy. eCTD allows regulators to use computer-based tools such as searching, copying and pasting text, making the review process more efficient. Additionally Agency staff can complete reviews online in less time than it would take using hard copies, which also benefits for sponsors. XML and PDF formats of eCTD submission can be viewed easily without much difficulty.
For sponsors, eCTD submissions also can be less expensive to produce and ship, provided they have business processes to accommodate the change from a paper-based format to an all-electronic one.
Use of eCTD has been rapidly increased. Submitting applications electronically benefits all parties. However, anyone who started out using paper submissions may have to unlearn some of the old ways of doing things to be successful with the eCTD format. With e-submission becoming mandatory, smaller companies, less technologically advanced companies and those with fewer resources may be particularly challenged.
Considering the need of hour, know how of eCTD, how to prepare it and software for its preparation needs attention of the regulatory professional. This review provides brief overview of these software.
This is integrated suite of different sotware such as integrated eCTD / NeeS / VNeeS software products that can be of great use for the creation, validation, publishing, viewing and manipulation of regulatory documentation for electronic submissions by pharmaceutical companies to regulatory authorities.
This eCTD software includes eCTD Compilers, NeeS Compilers, Vet NeeS Compiler, and e-submission tools.
Master control software provides advantages of automated Document Control / document Management; secure, Web-based location where access to submissions documents can be easily controlled. Master control is Quality Management System (QMS) provider for US FDA.
pharmaREADY bring all parts together, regulatory compliant, web-based suite comprised of Document Management, Training Records Management, Structured Product Labelling, and eCTD Publishing Solutions. pharmaREADY simplifies the complex process of creating, viewing, and managing submissions – electronic, NeeS or paper.
4. Extedo (USA) IABG LSS
eCTD Manager of Extedo has distinct advantages, which include rapid compliance with latest regulatory changes worldwide, ability to validate and publish submissions from a single application, submission quality and consistency improvement, support in publication of eSubmissions and paper-based submissions in structures and formats for all regions of the world, ready for eCTD 4.0 (RPS) (a future standard), support of parallel work locally and worldwide, sophisticated management of hyperlinks and bookmarks, conformance with ICH and regional filenames and 21 CFR Part 11, low hardware requirements, rapid deployment and system validation, and high performance and minimum training.
eCTD Builder from dataform abstracts the complexity of XML backbone and directory structure. It provides a simple and easy-to-use user interface with multiple regions support that includes Canada, EU, Japan and US.
eCTDViewer is a universal review application supporting all types of eCTD applications created based on ICH and regional DTD specifications.
Developed based on the requirements published by multiple agencies and our industry partners, this application provide the capability to receive, validate, review and archive eCTD submissions.
6. Image Solutions
eCTDXPress is ISI’s latest web-based solution for creating, managing eCTD lifecycles, and reviewing eCTD submissions. The application satisfies both regulatory agencies’ and industry sponsors’ requirements for reviewing, compiling, publishing and archiving of multi-region eCTD submissions. eCTDXPress allows users to separate technology from content, which improves productivity and time-to-market.
docuBridge.express from Lorenz is the fast and simple start to publishing eCTDs as well as CTDs. Designed for the small enterprises, it comes pre-packaged with all necessary software licenses to create electronic and paper submissions. This concept also ensures time-to-productivity is kept to a minimum.
docuBridge.Validator is the validation tool available free-of charge as a stand-alone utility via the LORENZ web-site. Any docuBridge.com users will find that the tool is included as part of the docuBridge.com applications & services and will be updated as part of the annual service package.
eCTD Composer of MedXView helps in making a valid eCTD submission within less time and lack of errors. eCTDcomposer ensures competitive edge, helping in making fast and accurate eCTD submissions according to the federally mandated guidelines.
9. TAKE Solutions
PharmaReady eCTD software is a web-based eCTD solution specifically designed for regulatory affairs areas in Health Science organizations where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers.
10. Thomson Liquent
Submissio Accelerator is a complimentary module for CoreDossier® automates the assembly and publishing of compliant eCTD dossiers, including the XML backbones for regional content. Currently Liquent is part of Parexel’s regulatory services.
Need of Training
Many of the times, these service providers do provide training of preparation of eCTD using their software suite. However, some amount of training of drafting eCTD is needed and can be obtained from training courses such as Post Graduate Diploma in Regulatory Affairs (PGDRA). This can provide you knowledge of drafting both DMF and CTD.
eCTD is ultimate need to get approval of your product in regulatory markets. Although, currently many semi-regulated markets do not demnad for eCTD, but sooner they will follow the trend. Knowledge of these software is therefore ultimate need. For small companies, currently use of software based on price comparision and features is needed before making decision of purchase. Training in this area is therefore necessary.
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