EU eCTD:
Implementation of the EU M1 specification v1.4 .
The Specifications and DTD of the eCTD EU Module 1 v1.4 include several changes to v1.3
based on change requests (see Release Notes for EU M1 v1.4), but the principal change is
support for the Commission Regulation (EC) No. 1234/2008 on variations, specifically the
support of grouped variations and worksharing.
Swiss eCTD:
Electronic-only submissions for a defined number of application types will be accepted from 1 January 2010.
The Swiss Module 1 Specification follows closely the EU Module 1 Specification. However, due to the regional requirements, there are a few differences.
eCTD Office is a suite of integrated NeeS / eCTD software products for the creation, validation, viewing, manipulation, life-cycle management and archiving of NeeS / eCTD submissions by pharmaceutical companies to the regulatory authorities.
NeeS Compiler is a next generation off-the-shelf Windows application for building
error-free non-eCTD electronic submissions for Europe. NeeS Compiler provides tools
for quick and intuitive construction of complex, valid non-eCTD electronic submissions.
(Automatic pdf 1.4
conversion / linearization)
eCTD Compiler is an off-the-shelf eCTD (Electronic Common Technical Document)
validation, creation, viewing, manipulation and archiving system for EU/CH electronic
submissions. eCTD Compiler extends NeeS Compiler by adding eCTD specific features like
Envelope creation and lifecycle management.
(Building eCTD , Importing eCTD, Converting: NeeS > eCTD, Converting eCTD > NeeS)
eCTD Lifecycle tool features history view of submission sequences, allowing the user
to approve documents, search, preview, etc.