Swissmedic has released the new version 1.2 of the Swiss
Module 1 eCTD specification. The full set of documents released in this context
comprises
Guidance for Industry on Providing Regulatory Information in eCTD Format
v1.4 ("clean" version and "track change" version)
Q&A v1.6 ("clean" version and "track change" version)
Validation criteria v1.2
Release notes for the new validation criteria v1.2
Implementation schedule:
The eCTD specification 1.2
will be implemented on July 01, 2013 and can be used by applicants from that
point onwards. The current version 1.1 will still be valid during a transition
period until December 31, 2013 . From January 01, 2014 the usage of the new
CH Module 1 specification 1.2 will be mandatory for eCTD submissions to
Swissmedic. Note that eCTDs that have switched to the new version 1.2
during the transition period cannot be switched back to version 1.1.
Guidance for Industry:
The Guidance version 1.4
contains only very limited modifications compared to the last version. The
change introduced considers the alignment of the new eCTD validation criteria
for Switzerland with the existing EU eCTD validation criteria (see below).
Details are obtainable from the "track change" version.
Q&A:
Also the Q&A have been modified in a
rather moderate fashion. Some Q&A have been updated due to the alignment of
the Swiss eCTD validation criteria with the current EU eCTD validation criteria
(3-3-2, 5-4 updated, 5-12 deleted). New dedicated eCTD subsections for some
forms have been introduced in section 1.2.2. Corresponding Q&As 3-3-5,
3-3-6, and 6-9 have been updated accordingly.
A major update of the eCTD Module 1 specification 1.2 concerns
the Swiss Administrative Metadata in Module 1 ("envelope"). Among the changes,
the envelope element "application" is now repeatable. The corresponding Q&A
5-5 has been updated. See "track change" version of the Q&A for details.
eCTD Validation Criteria:
The new
Swiss eCTD Module 1 validation criteria have been aligned with the current EU
eCTD Module 1 validation criteria. As a major consequence the previous
classification of "A", "B", and "C" validation errors has been changed to
"Pass/Fail" criteria (P/F) and "Best Practice Guidance" (BPG) criteria. Details
can be obtained from the release notes.
Swiss eCTD Module 1 specification 1.2:
Numerous changes have been introduced, the key changes
are:
- File formats: .docx Word 2007 file formats are allowed now; the requirement
for additional MS Word formatted files for Module 2 documents have been removed.
- Table 1 detailing the possible switch to a subfolder "common" for a Module 1
with a 2nd galenic form branch for certain documents and the
corresponding allowed life cycle operation attributes have been updated
completely.
- Clarification regarding country codes for United Kingdom ("uk" allowed),
Greece ("el" allowed) and EU Centralized ("ema" or "emea" allowed) has been
introduced
- An additional row including the "Directory" name has been introduced on file
level in Table 4 detailing the directory / file structure for a Swiss Module 1.
Previously this information was covered by the "File" information.
- Additional directory / file names have been specified for some forms. This
resulted in new subsections 1.2.2.21 - 1.2.2.24.
- Appendix 2 with the "Envelope Element Description" has been largely
updated
For More information
http://www.swissmedic.ch/zulassungen/00933/00937/index.html?lang=en
