NeeS / VNeeS / eCTD N E W S
Release Announcement: eCTD Office - Full Support for Swiss eCTD Version 1.1
Mono Software and PRS today announced the major new release of the eCTD Office Suite, widely used NeeS / VNeeS / eCTD publishing system for EU and Swiss eCTD / NeeS electronic submissions.
eCTD Office in its latest version includes the following new features:
- Full support for Swiss Module 1 Specification for eCTD, Version 1.1.
- eCTD Envelope Explorer.
- Templated Compiler
- Various enhancements and new features to make your esubmission publishing more user friendly, easier and faster.
Release Announcement: eChecker - FREE VNeeS Validation Tool
Mono Software and PRS today announced the release of the first VNeeS (veterinary e-submission) validation tool: eChecker.
eCTD Office eChecker (VNeeS Validator) is a super fast and accurate, off-the-shelf veterinary electronic submissions (VNeeS) validation system. eCTD Office eChecker allows for import of the VNeeS folder / file structure to report whether the structure conforms to the VNeeS format (immunological or pharmaceutical).
eChecker was built on top of the specifications published in the "Guideline on the specifications for provision of an electronic submission (e submission) for a veterinary medicinal product" - published and maintained by the TIGes-Vet.
eCTD Office is a suite of integrated NeeS / VNeeS / eCTD software products for the creation, validation, viewing, manipulation and archiving of NeeS / VNeeS / eCTD submissions of regulatory documentation by pharmaceutical companies to the regulatory authorities.
VNeeS (Veterinary eSubmission) Compiler Released!
VNeeS Compiler, a part of eCTD Office, is a next generation off-the-shelf Windows software application for building error-free eSubmission for Veterinary Applications.
VNeeS Compiler follows guideline on the specifications for provision of an electronic submission (e submission) for a veterinary medicinal product published by EMEA (TIGes-Vet).
Swiss / CH eCTD Compiler Released!
Swiss / CH eCTD Compiler, a apart of eCTD Office, is a next generation off-the-shelf eCTD (Electronic Common Technical Document) validation, creation, viewing, manipulation and archiving system for Swiss electronic submissions. The main functionality of the Swiss eCTD Compiler is the creation of the eCTD XML backbone (+ envelope data) along with the lifecycle management.
CMD(h) Best Practice Guide on the use of eCTD in the MRP/DCP
Further to experience gained both by Industry and National Competent Authorities, the CMD(h) has reviewed the Best Practice Guide on the use of eCTD in the MRP and DCP.
According to the document, there should always be a structured so called Tracking table included as an annex to the Cover Letter placed within the ‘common’ directory with the filename common-cover-tracking.pdf or common-cover-tracking.xml.
MRP/DCP Tracking Table Builder, a part of eCTD Office, is a visual Tracking Table XML builder to be used in the context of Mutual Recognition and Decentralised Procedures.
Belgian Checker New Release version 2.8
The Checker is widened by restrictions in accordance with the latest NeeS and eCTD specifications. NeeS Compiler meets all Belgian Checker criteria.
Announcement: Swiss Module 1 Specification in eCTD Office
During the coming months eCTD Office will be extended to support the creation of eCTD submissions for the Swiss Agency for Therapeutic
Products (Swissmedic).
MRP/DCP Tracking Table Builder added to eCTD Office
MRP/DCP Tracking Table Builder, a part of eCTD Office, is a visual Tracking Table XML builder to be used in the context of Mutual Recognition and Decentralised Procedures, under the Module 1 of the electronic Common Technical Document (eCTD) for the European Union (EU).
eCTD EU Module 1 version 1.4 Implemented in eCTD Office
eCTD Compiler EU M1 envelope creation has been updated to support the new Variation Regulation coming into force 1st January 2010. New elements include: additional submission type, submission mode, tracking number, IG number, 180 characters max path, ...
eCTD EU Module 1 version 1.4
The EU M1 1.4 Specification has been released. The EU M1 has been updated to support the new Variation Regulation coming into force 1st January 2010. EU M1 v1.4 is mandatory from 1st January 2010 for all grouped variation submissions and submissions subject to a worksharing agreement, and from 1st July 2010 v1.4 will be mandatory for all eCTD submissions for all procedures.
The TIGes has agreed on a final draft of a harmonised guidance document (1.4) for the submission of non-eCTD electronic submissions ('NeeS') until the end of 2009.
eCTD Office - eCTD Submission example
Here's an example of an eCTD XML submission: the EU CTD Guidance stored as an eCTD submission (points to the index XML of an arbitrary eCTD submission).
Note: this submission was completed in only 35 minutes:
- 30 minutes were needed to create the NeeS folder structure using NeeS Compiler (creating links to pdf documents and splitting),
- less than 1 minute to check the structure
eCTD Specs Version 3.2.2
The eCTD Specification document was updated to incorporate numerous approved Change Requests. The new version is 3.2.2. Only the narrative portion of the document was changed. The DTD and stylesheet have remained unchanged.