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Archive for the ‘Swissmedic’ Category

News Roundup Part 1: Agency News

posted by mr.erhabi511 @ 8:32 PM
Thursday, August 12, 2010

Today’s post is a round-up of recent eSubmission-related news from the agencies, based on posts from my twitter account,  Next time, a roundup of articles and conferences.

The regulatory authorities haven’t put out much in the way of major updates recently, but there have been some updates worth noting:

The individual agencies in Europe have also issued some updates:

As promised, here is an expanded list of posts published recently on my twitter account, this time related to agency news:

EMEA and SwissMedic News

posted by mr.erhabi511 @ 5:58 PM
Monday, September 21, 2009
EMEA has released new versions of their electronic Application Forms (eAF) as part of Volume 2B – Presentation and content of the dossier.  All three forms (for new applications, variations and renewals) have been posted.  Updates are due to changes in the Data Exchange Standard Definitions released July 2009.  Changes are significant, so if you have done any custom development around the eAF, you will need to make a number of updates.  For those waiting for the EMEA to provide a front end for creating the form, you will only have to provide some additional information when filling in the form.
SwissMedic M1 specification v0.93 is available by contacting Stephan Jaermann (   However, before you do so, you should be aware that this does not consist of documentation updates yet, but only updates to the DTDs, style sheets and sample submissions.  If you are not highly interested in the technical aspects, you should hold off until more formal updates are posted.  Version 0.95 will be posted on the website towards the end of September. The final v1.0 version will be posted mid to end of October.

New EMEA M1 Spec (V1.4) in August; Other Agency News

posted by mr.erhabi511 @ 9:36 PM
Thursday, July 16, 2009

EMEA has announced that they will be releasing a new M1 eCTD specification in early August.  EMEA will be releasing version 1.4, including a new DTD, implementation guide, transition guide, and validation guide.  According to Claire Holmes of EMEA, this new version will accommodate recent updates to guidance on variations.

The new version will be recommended from January 2010, and mandatory from February 2010.

Gary Gensinger of the FDA has also confirmed that a new US module 1 specification is in the works, with no target date announced yet.

As I reported earlier in the week, SwissMedic has released their draft eCTD M1 specification and validation criteria.  Stephan Jaermann of SwissMedic has stated that additional documentation – Guidance for Industry and Q&A – will follow soon.  The SwissMedic pilot program will continue through October, with implementation to follow.  Initially, only MAAs will be accepted, with Variations accepted in a future phase.  SwissMedic will still accept paper submissions for the foreseeable future, but all electronic submissions must be in eCTD format (no NeeS).

Addendum: SwissMedic has as of July 17 published Guidance for Industry on Providing Regulatory Information in eCTD Format and Questions and Answers of Swissmedic eCTD Implementation.

SwissMedic has issued a package of eCTD related specifications 

·        Swiss M1 Specification for eCTD

·         Other Documents (DTD/MOD)

·         Swiss eCTD Validation Criteria  

I have only done a cursory analysis as my day job is a bit overwhelming at the moment.  The specification differs notably from the EMEA spec in several areas:

·         SwissMedic has issued their own file and folder naming conventions for M1 as of course their M1 contents differ from EMEA

·         Module 1 metadata is different, and includes a SwissMedic number and the galenic (dosage) form in both English and other languages, and does not include ATC or procedure type

·         The DTD appears to allow M1 to be repeated per galenic form

·         The concept of regulatory activity, as implemented in related sequence, is present.  However, the concept of first and second level activities is not present as it is in EU/US.  For example, a sequence of type na-nas can relate to another sequence of type na-nas.

·         The leaf element includes some new attributes such as actuate-list and show-list, and gives a list of values.  However, these are not explained or even mentioned in the guidance document.

In other news, EMEA issued their guideline for e-submission for a veterinary medicinal product  The guideline specifies the basic parameters required for an acceptable electronic submission, and includes a specification for the folder structure (the granularity) to be used in a basic electronic submission to be known as VNeeS.  It does not mention eCTD.

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