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Swiss Drug Regulatory Agency Swissmedic has released an updated version 1.2 of their national "Questions & Answers of Swissmedic eCTD Implementation".
Many changes introduced in the new version of the Q&A document reflect the further progress of Swissmedic`s eCTD implementation project SIMES and the fact that since July 2010 the scope of eCTD applications has been widened (e.g. variations and applications acc. to §13 TPA have been included in the list of applications that are accepted in eCTD format, however some application types will not be accepted in eCTD format until January 2011.)
Addition of new Q&A:
3 Questions about the submission: - Q&A 3-45, addressing the date that should appear on corrected version of forms that needed to be updated ("replace") - in this case the forms should bear the new date.
- Q&A 3-46, dealing with collective applications that refer to products that have different existing formats (paper and eCTD) - in this case the collective application must be done once in eCTD and once in paper (unless the format of the referred product that was submitted in paper was switched to eCTD format). In this case, conversion to eCTD of dossiers from referred products is recommended by Swissmedic.
- Q&A 3-47 clarifies that leaf titles should be as meaningful and descriptive as possible
5 Questions about eCTD specification: - Q&A 5-3 explains the changes introduced in Swiss M1 specification 1.1 with regard to the number of occurrence of "galenic-name". Since 1.1 only one galenic-name is permitted
8 Questions about the submission of variations, DMFs, PMFs
and VAMFs in eCTD format: - Q&A 8-8 details how a Plasma Master File (PMF) should be submitted. In principle the scope is equal to the paper submission format but without the paper TOC. For details please see the Q&A document
- Q&A 8-9 recommends that variations requiring notification or applications requiring authorisation should be described in the cover letter
- Q&A 8-10 explains how the annual update of an influenza vaccine should be submitted. These annual updates are carried out in three steps: 1) Package material submitted in March; 2) Quality documentation submitted in June/July and 3) Clinical documentation submitted in July/August. With regard to the eCTD format for annual updates the submission of a baseline is highly recommended. This baseline should be provided in January the latest.
The eCTD sequence order would then be:
0000 baseline
0001 Packaging Material
0002 Quality
0003 Clinical
Further details on the requirements for annual vaccine updates and corresponding eCTD baseline submissions are included in the Q&A document.
Some changes to already existing Q&As have been introduced as well. The most significant one changes Q&A 4-1 and includes now temporary marketing authorisations, the notification procedure for sample packages and the Pharmacovigilance plan (PVP) in the list of applications that can be submitted in eCTD format starting January 2011.
The new version of the Q&A document is available for download from the Swissmedic website in clean and track-change format.
[Source: Swissmedic website]
- Related News:
 CH: Swissmedic releases Swiss M1 eCTD specification v1.1 and associated documents - 25.05.2010 16:45- CH: Swissmedic releases final regional eCTD M1 specification - 30.10.2009 09:40
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